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| ID | Type | Description | Link |
|---|---|---|---|
| NCCTG-N08CB | |||
| CDR0000669660 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-2011-02036 | Registry Identifier | CTRP (Clinical Trials Reporting System) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Chemoprotective drugs, such as calcium gluconate and magnesium sulfate, may prevent neurotoxicity caused by oxaliplatin. It is not yet known which administration schedule of calcium gluconate and magnesium sulfate is more effective in preventing neurotoxicity.
PURPOSE: This randomized phase III trial is studying different administration schedules of calcium gluconate and magnesium sulfate and comparing how well they work in neurotoxicity in patients with colon cancer or rectal cancer receiving oxaliplatin-based combination chemotherapy.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study. Patients are stratified according to age (< 65 years vs ≥ 65 years), gender, regimen (FOLFOX4 vs modified FOLFOX6 vs other), and stage of disease (II vs III vs IV). Patients are randomized to 1 of 3 treatment arms.
In all arms, courses repeat every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.
Blood samples are collected before the second course of treatment for translational research.
Patients complete questionnaires on side effects, quality of life, and chemotherapy-induced peripheral neuropathy periodically.
After completion of study treatment, patients are followed up at 3, 6, 12, and 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin). |
|
| Arm II | Placebo Comparator | Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy). |
|
| Arm III | Experimental | Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcium gluconate | Drug | Given IV |
| |
| magnesium sulfate |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory Area Under the Curve(AUC) Score. Oxaliplatin-induced Sensory Neuropathy as Repeatedly Measured by the EORTC QLQ-CIPN20 Sensory Subscale During Chemotherapy | The oxaliplatin-induced sensory neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) sensory subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 sensory subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 sensory subscale as the primary endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received. | Up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Autonomic Neuropathy Subscale Scores | The oxaliplatin-induced autonomic neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) autonomic subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN autonomic subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 autonomic subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 autonomic subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received. |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon or rectum
Has undergone curative resection and is considered to have stage II or III disease or completely resected stage IV disease with no evidence of residual tumor
Scheduled to receive 6 months of oxaliplatin-based adjuvant chemotherapy with 85 mg/m^2 oxaliplatin every 2 weeks (this includes, for instance, FOLFOX4 or modified FOLFOX6)
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
WBC ≥ 3,000/mm^3
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10.0 g/dL
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
Serum creatinine ≤ 1.5 times ULN
Serum calcium ≤ 1.2 times ULN
Serum magnesium ≤ 1.2 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to complete questionnaires (alone or with assistance)
Able to comply with study treatment
Willing to return to enrolling institution for follow-up
Willing to provide blood sample for research purposes
No pre-existing peripheral neuropathy of any grade
No family history of a genetic/familial neuropathy
No second or third degree AV heart block or a history of second or third degree heart block
No other medical conditions that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Charles L. Loprinzi, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital | Fairbanks | Alaska | 99701 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34176021 | Derived | Hertz DL, Dockter TJ, Satele DV, Loprinzi CL, Le-Rademacher J. Neuropathy severity at the time of oxaliplatin treatment alteration in patients with colon cancer (Alliance A151912). Support Care Cancer. 2021 Dec;29(12):7855-7863. doi: 10.1007/s00520-021-06371-x. Epub 2021 Jun 27. | |
| 24297951 | Derived | Loprinzi CL, Qin R, Dakhil SR, Fehrenbacher L, Flynn KA, Atherton P, Seisler D, Qamar R, Lewis GC, Grothey A. Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance). J Clin Oncol. 2014 Apr 1;32(10):997-1005. doi: 10.1200/JCO.2013.52.0536. Epub 2013 Dec 2. |
| Label | URL |
|---|---|
| Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcium Gluconate + Magnesium Sulfate (Pre and Post) | Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin). |
| FG001 | Placebo (Pre and Post) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Given IV |
|
| placebo | Other | Given IV |
|
| oxaliplatin | Drug |
|
| Up to 18 months |
| Area Under the Curve (AUC) of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Motor Neuropathy Subscale Scores | The oxaliplatin-induced motor neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) motor neuropathy subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN motor neuropathy subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 motor neuropathy subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 motor neuropathy subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received. | Up to 18 Months |
| Percentage of Patients Experiencing Grade 2+ and Grade 3+ Chronic Cumulative Neurotoxicity. | Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event. | Up to 18 months |
| Time to Onset of Grade 2+ and Grade 3+ Chronic Cumulative Neurotoxicity and the Duration of the Chronic Cumulative Neurotoxicity During and After Chemotherapy | Time to onset of grade 2+ and grade 3+ chronic cumulative neurotoxicity, the duration of the chronic cumulative neurotoxicity during and after the adjuvant oxaliplatin-based chemotherapy. Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event. | Up to 18 months |
| Cumulative Oxaliplatin Doses That Can be Administered Without Dose-limiting Chronic Neurotoxicity | A patient has a dose-limiting chronic neurotoxicity when they discontinue oxaliplatin-based chemotherapy because of neurotoxicity. | Up to 18 months |
| Percentage of Patients Discontinuing Oxaliplatin-based Chemotherapy Because of Neurotoxicity | Up to 18 months |
| Percentage of Patients With Acute Neuropathy Associated With Oxaliplatin | This is the percent of patients who scored >=50 in all sequences of all cycles by arm for side effect Q1: Sensitivity to touching cold. This is a> repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN subscale will be calculated by standard scoring algorithm and converted to 0-100 scale. Where 0 is no sensitivity and 100 is as bad as it can be. | Up to 18 months |
| Incidence of Calcium Gluconate and Magnesium Sulfate-induced Adverse Events as Measured by CTCAE Version 4.0 | Up to 18 months |
| Area Under the Curve (AUC) of Patient-reported Quality of Life (QOL) as Measured by the Supplemental QOL Questionnaire | This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The supplemental quality of life (QOL) subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) . This AUC will be prorated by the number of chemotherapy cycles patients received. | Up to 18 months |
| Kaiser Permanente - Deer Valley |
| Antioch |
| California |
| 94531 |
| United States |
| North Bay Cancer Center | Fairfield | California | 94533 | United States |
| Kaiser Permanente - Fremont | Fremont | California | 94538 | United States |
| Kaiser Permanente Fresno Medical Center | Fresno | California | 93720 | United States |
| Kaiser Permanente Medical Center - Hayward | Hayward | California | 94545 | United States |
| Kaiser Permanente Medical Center - Oakland | Oakland | California | 94611 | United States |
| Pismo Beach | California | 93449 | United States |
| Kaiser Permanente Medical Center - Redwood City | Redwood City | California | 94063 | United States |
| Kaiser Permanente Medical Center - Richmond | Richmond | California | 94801 | United States |
| Kaiser Permanente Medical Center - Roseville | Roseville | California | 95661 | United States |
| South Sacramento Kaiser-Permanente Medical Center | Sacramento | California | 95823 | United States |
| Kaiser Permanente Medical Center - Sacramento | Sacramento | California | 95825 | United States |
| Kaiser Permanente Medical Center - San Francisco Geary Campus | San Francisco | California | 94115 | United States |
| Kaiser Permanente Medical Center - Santa Teresa | San Jose | California | 95119 | United States |
| Kaiser Foundation Hospital - San Rafael | San Rafael | California | 94903 | United States |
| Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara | California | 95051 | United States |
| Kaiser Permanente Medical Center - Santa Rosa | Santa Rosa | California | 95403 | United States |
| Kaiser Permanente Medical Center - South San Francisco | South San Francisco | California | 94080 | United States |
| Kaiser Permanente Medical Facility - Stockton | Stockton | California | 95210 | United States |
| Kaiser Permanente Medical Center - Vacaville | Vacaville | California | 95688 | United States |
| Kaiser Permanente Medical Center - Vallejo | Vallejo | California | 94589 | United States |
| Kaiser Permanente Medical Center - Walnut Creek | Walnut Creek | California | 94596 | United States |
| Aurora Presbyterian Hospital | Aurora | Colorado | 80012 | United States |
| Boulder Community Hospital | Boulder | Colorado | 80301-9019 | United States |
| Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado | 80933 | United States |
| St. Anthony Central Hospital | Denver | Colorado | 80204 | United States |
| Kaiser Permanente - Denver | Denver | Colorado | 80205 | United States |
| Porter Adventist Hospital | Denver | Colorado | 80210 | United States |
| Presbyterian - St. Luke's Medical Center | Denver | Colorado | 80218 | United States |
| St. Joseph Hospital | Denver | Colorado | 80218 | United States |
| Rose Medical Center | Denver | Colorado | 80220 | United States |
| CCOP - Colorado Cancer Research Program | Denver | Colorado | 80224-2522 | United States |
| Swedish Medical Center | Englewood | Colorado | 80110 | United States |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado | 81502 | United States |
| North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| Kaiser Permanente - Lafayette | Lafayette | Colorado | 80026 | United States |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | United States |
| Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado | 80501 | United States |
| McKee Medical Center | Loveland | Colorado | 80539 | United States |
| St. Mary - Corwin Regional Medical Center | Pueblo | Colorado | 81004 | United States |
| North Suburban Medical Center | Thornton | Colorado | 80229 | United States |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | United States |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | 19958 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| North Broward Medical Center | Deerfield Beach | Florida | 33064-3596 | United States |
| Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Broward General Medical Center Cancer Center | Fort Lauderdale | Florida | 33316 | United States |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida | 33458 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | 32803-1273 | United States |
| Phoebe Cancer Center at Phoebe Putney Memorial Hospital | Albany | Georgia | 31701 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Northside Hospital Cancer Center | Atlanta | Georgia | 30342-1611 | United States |
| Saint Joseph's Hospital of Atlanta | Atlanta | Georgia | 30342-1701 | United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342 | United States |
| WellStar Cobb Hospital | Austell | Georgia | 30106 | United States |
| John B. Amos Cancer Center | Columbus | Georgia | 31904 | United States |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur | Georgia | 30033 | United States |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia | 30033 | United States |
| Piedmont Fayette Hospital | Fayetteville | Georgia | 30214 | United States |
| Gwinnett Medical Center | Lawrenceville | Georgia | 30045 | United States |
| Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta | Georgia | 30060 | United States |
| Southern Regional Medical Center | Riverdale | Georgia | 30274-2600 | United States |
| Harbin Clinic Cancer Center - Medical Oncology | Rome | Georgia | 30165 | United States |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | 31403-3089 | United States |
| Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah | Georgia | 31405 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | United States |
| OnCare Hawaii, Incorporated - Lusitana | Honolulu | Hawaii | 96813 | United States |
| Queen's Cancer Institute at Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| Straub Clinic and Hospital, Incorporated | Honolulu | Hawaii | 96813 | United States |
| Hawaii Medical Center - East | Honolulu | Hawaii | 96817 | United States |
| OnCare Hawaii, Incorporated - Kuakini | Honolulu | Hawaii | 96817 | United States |
| Kaiser Permanente - Moanalua Medical Center and Clinic | Honolulu | Hawaii | 96819 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Tripler Army Medical Center | Honolulu | Hawaii | 96859 | United States |
| Maui Memorial Medical Center | Wailuku | Hawaii | 96793 | United States |
| Pacific Cancer Institute - Maui | Wailuku | Hawaii | 96793 | United States |
| Kapiolani Medical Center at Pali Momi | ‘Aiea | Hawaii | 96701 | United States |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | United States |
| St. Joseph Regional Medical Center | Lewiston | Idaho | 83501 | United States |
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60504 | United States |
| Illinois CancerCare - Bloomington | Bloomington | Illinois | 61701 | United States |
| Graham Hospital | Canton | Illinois | 61520 | United States |
| Illinois CancerCare - Canton | Canton | Illinois | 61520 | United States |
| Illinois CancerCare - Carthage | Carthage | Illinois | 62321 | United States |
| Memorial Hospital | Carthage | Illinois | 62321 | United States |
| University of Illinois Cancer Center | Chicago | Illinois | 60612-7243 | United States |
| Louis A. Weiss Memorial Hospital | Chicago | Illinois | 60640 | United States |
| Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois | 62526 | United States |
| Eureka Community Hospital | Eureka | Illinois | 61530 | United States |
| Illinois CancerCare - Eureka | Eureka | Illinois | 61530 | United States |
| Galesburg Clinic, PC | Galesburg | Illinois | 61401 | United States |
| Illinois CancerCare - Galesburg | Galesburg | Illinois | 61401 | United States |
| Illinois CancerCare - Havana | Havana | Illinois | 62644 | United States |
| Mason District Hospital | Havana | Illinois | 62644 | United States |
| Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois | 61443 | United States |
| Illinois CancerCare - Macomb | Macomb | Illinois | 61455 | United States |
| McDonough District Hospital | Macomb | Illinois | 61455 | United States |
| Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline | Illinois | 61265 | United States |
| Moline | Illinois | 61265 | United States |
| Illinois CancerCare - Monmouth | Monmouth | Illinois | 61462 | United States |
| BroMenn Regional Medical Center | Normal | Illinois | 61761 | United States |
| Community Cancer Center | Normal | Illinois | 61761 | United States |
| Illinois CancerCare - Community Cancer Center | Normal | Illinois | 61761 | United States |
| Community Hospital of Ottawa | Ottawa | Illinois | 61350 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | 61350 | United States |
| Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | 61554 | United States |
| Illinois CancerCare - Pekin | Pekin | Illinois | 61603 | United States |
| Proctor Hospital | Peoria | Illinois | 61614 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| Illinois CancerCare - Peru | Peru | Illinois | 61354 | United States |
| Illinois Valley Community Hospital | Peru | Illinois | 61354 | United States |
| Illinois CancerCare - Princeton | Princeton | Illinois | 61356 | United States |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | United States |
| West Suburban Center for Cancer Care | River Forest | Illinois | 60305 | United States |
| Illinois CancerCare - Spring Valley | Spring Valley | Illinois | 61362 | United States |
| Regional Cancer Center at Memorial Medical Center | Springfield | Illinois | 62781-0001 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| Elkhart Clinic, LLC | Elkhart | Indiana | 46514-2098 | United States |
| Michiana Hematology-Oncology, PC - Elkhart | Elkhart | Indiana | 46514 | United States |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | United States |
| Howard Community Hospital | Kokomo | Indiana | 46904 | United States |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | United States |
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| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | United States |
| Michiana Hematology-Oncology, PC - South Bend | Mishawaka | Indiana | 46545-1470 | United States |
| Saint Joseph Regional Medical Center | Mishawaka | Indiana | 46545-1470 | United States |
| Michiana Hematology Oncology PC - Plymouth | Plymouth | Indiana | 46563 | United States |
| Reid Hospital & Health Care Services | Richmond | Indiana | 47374 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Michiana Hematology Oncology PC - La Porte | Westville | Indiana | 46391 | United States |
| Bettendorf | Iowa | 52722 | United States |
| Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | 52403 | United States |
| Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | United States |
| Medical Oncology and Hematology Associates - West Des Moines | Clive | Iowa | 50325 | United States |
| Mercy Cancer Center - West Lakes | Clive | Iowa | 50325 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | 50314 | United States |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | United States |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51102 | United States |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | United States |
| Covenant Cancer Treatment Center | Waterloo | Iowa | 50702 | United States |
| Methodist West Hospital | West Des Moines | Iowa | 50266-7700 | United States |
| Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | 66701 | United States |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | United States |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| Cancer Center of Kansas, PA - Liberal | Liberal | Kansas | 67901 | United States |
| Cancer Center of Kansas, PA - McPherson | McPherson | Kansas | 67460 | United States |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | United States |
| Menorah Medical Center | Overland Park | Kansas | 66209 | United States |
| Saint Luke's Hospital - South | Overland Park | Kansas | 66213 | United States |
| Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | 67357 | United States |
| CCOP - Kansas City | Prairie Village | Kansas | 66208 | United States |
| Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas, PA - Salina | Salina | Kansas | 67401 | United States |
| Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health, PA - North Review | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | 67214 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214 | United States |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | 67156 | United States |
| MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Medical Center of Louisiana - New Orleans | New Orleans | Louisiana | 70112 | United States |
| York Hospital's Oncology Treatment Center | York Village | Maine | 03909 | United States |
| Shore Regional Cancer Center at Memorial Hospital - Easton | Easton | Maryland | 21601 | United States |
| Union Hospital of Cecil County | Elkton | Maryland | 21921 | United States |
| Sturdy Memorial Hospital | Attleboro | Massachusetts | 02703 | United States |
| Boston University Cancer Research Center | Boston | Massachusetts | 02118 | United States |
| Caritas St. Elizabeth's Medical Center | Brighton | Massachusetts | 02135-2997 | United States |
| Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | 49221 | United States |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | 48123-2500 | United States |
| Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan | 49431 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Dickinson County Healthcare System | Iron Mountain | Michigan | 49801 | United States |
| Foote Memorial Hospital | Jackson | Michigan | 49201 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48912-1811 | United States |
| St. Mary Mercy Hospital | Livonia | Michigan | 48154 | United States |
| Community Cancer Center of Monroe | Monroe | Michigan | 48162 | United States |
| Mercy Memorial Hospital - Monroe | Monroe | Michigan | 48162 | United States |
| Michiana Hematology Oncology PC - Niles | Niles | Michigan | 49120 | United States |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48341-2985 | United States |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan | 48060 | United States |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | 48073 | United States |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | 48601 | United States |
| Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | 49085 | United States |
| Lakeside Cancer Specialists, PLLC | Saint Joseph | Michigan | 49085 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48093 | United States |
| Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | 55805-1983 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805 | United States |
| Miller - Dwan Medical Center | Duluth | Minnesota | 55805 | United States |
| Immanuel St. Joseph's | Mankato | Minnesota | 56002 | United States |
| Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | 55415 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi | 39581 | United States |
| Southeast Cancer Center | Cape Girardeau | Missouri | 63703 | United States |
| Saint Luke's Hospital | Chesterfield | Missouri | 63017 | United States |
| Goldschmidt Cancer Center | Jefferson City | Missouri | 65109 | United States |
| Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| North Kansas City Hospital | Kansas City | Missouri | 64116 | United States |
| Parvin Radiation Oncology | Kansas City | Missouri | 64116 | United States |
| Heartland Hematology Oncology Associates, Incorporated | Kansas City | Missouri | 64118 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Saint Luke's East - Lee's Summit | Lee's Summit | Missouri | 64086 | United States |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | United States |
| Saint Joseph Oncology, Incorporated | Saint Joseph | Missouri | 64507 | United States |
| Saint Louis University Cancer Center | St Louis | Missouri | 63110 | United States |
| St. Anthony's Cancer Center | St Louis | Missouri | 63128 | United States |
| Missouri Baptist Cancer Center | St Louis | Missouri | 63131 | United States |
| Comprehensive Cancer Care, PC | St Louis | Missouri | 63141 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare Cancer Care Services | Billings | Montana | 59101 | United States |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59102 | United States |
| Billings Clinic - Downtown | Billings | Montana | 59107-7000 | United States |
| Bozeman Deaconess Cancer Center | Bozeman | Montana | 59715 | United States |
| St. James Healthcare Cancer Care | Butte | Montana | 59701 | United States |
| Big Sky Oncology | Great Falls | Montana | 59405-5309 | United States |
| Great Falls Clinic - Main Facility | Great Falls | Montana | 59405 | United States |
| Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | 59405 | United States |
| Northern Montana Hospital | Havre | Montana | 59501 | United States |
| St. Peter's Hospital | Helena | Montana | 59601 | United States |
| Glacier Oncology, PLLC | Kalispell | Montana | 59901 | United States |
| Kalispell Medical Oncology at KRMC | Kalispell | Montana | 59901 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | 59807-7877 | United States |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | 59807 | United States |
| Cancer Resource Center - Lincoln | Lincoln | Nebraska | 68510 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Immanuel Medical Center | Omaha | Nebraska | 68122 | United States |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131-2197 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord | New Hampshire | 03301 | United States |
| Center for Cancer Care at Exeter Hospital | Exeter | New Hampshire | 03833 | United States |
| New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett | New Hampshire | 03106 | United States |
| Lakes Region General Hospital | Laconia | New Hampshire | 03246 | United States |
| Oncology Center at St. Joseph Hospital | Nashua | New Hampshire | 03060 | United States |
| Trinitas Comprehensive Cancer Center at Trinitas Hospital | Elizabeth | New Jersey | 07207 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Kings County Hospital Center | Brooklyn | New York | 11203 | United States |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Veterans Affairs Medical Center - Brooklyn | Brooklyn | New York | 11209 | United States |
| Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital | Cooperstown | New York | 13326 | United States |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | 13057 | United States |
| Monter Cancer Center of the North Shore-LIJ Health System | Lake Success | New York | 11042 | United States |
| CCOP - North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center | Plattsburgh | New York | 12901 | United States |
| Randolph Hospital | Asheboro | North Carolina | 27203-5400 | United States |
| CaroMont Cancer Center at Gaston Memorial Hospital | Gastonia | North Carolina | 28053 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro | North Carolina | 27403-1198 | United States |
| Pardee Memorial Hospital | Hendersonville | North Carolina | 28791 | United States |
| FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst | North Carolina | 28374 | United States |
| Annie Penn Cancer Center | Reidsville | North Carolina | 27320 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | United States |
| Iredell Memorial Hospital | Statesville | North Carolina | 28677 | United States |
| Bismarck Cancer Center | Bismarck | North Dakota | 58501 | United States |
| Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota | 58501 | United States |
| Mid Dakota Clinic, PC | Bismarck | North Dakota | 58501 | United States |
| St. Alexius Medical Center Cancer Center | Bismarck | North Dakota | 58502 | United States |
| Altru Cancer Center at Altru Hospital | Grand Forks | North Dakota | 58201 | United States |
| Trinity CancerCare Center | Minot | North Dakota | 58701 | United States |
| McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Wood County Oncology Center | Bowling Green | Ohio | 43402 | United States |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| CCOP - Dayton | Dayton | Ohio | 45420 | United States |
| Community Cancer Center | Elyria | Ohio | 44035 | United States |
| Hematology Oncology Center | Elyria | Ohio | 44035 | United States |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | United States |
| Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Wayne Hospital | Greenville | Ohio | 45331 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| St. Rita's Medical Center | Lima | Ohio | 45801 | United States |
| Lima Memorial Hospital | Lima | Ohio | 45804 | United States |
| Northwest Ohio Oncology Center | Maumee | Ohio | 43537-1839 | United States |
| St. Charles Mercy Hospital | Oregon | Ohio | 43616 | United States |
| Toledo Clinic - Oregon | Oregon | Ohio | 43616 | United States |
| North Coast Cancer Care, Incorporated | Sandusky | Ohio | 44870 | United States |
| Flower Hospital Cancer Center | Sylvania | Ohio | 43560 | United States |
| Mercy Hospital of Tiffin | Tiffin | Ohio | 44883 | United States |
| Toledo Hospital | Toledo | Ohio | 43606 | United States |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | United States |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43617 | United States |
| St. Anne Mercy Hospital | Toledo | Ohio | 43623 | United States |
| Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | 43623 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| Fulton County Health Center | Wauseon | Ohio | 43567 | United States |
| United States Air Force Medical Center - Wright-Patterson | Wright-Patterson Air Force Base | Ohio | 45433-5529 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| LaFortune Cancer Center at St. John Medical Center | Tulsa | Oklahoma | 74104 | United States |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | 74136 | United States |
| Kaiser Permanente Health Care - Portland | Portland | Oregon | 97227 | United States |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | 18105 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | United States |
| Geisinger Hazleton Cancer Center | Hazleton | Pennsylvania | 18201 | United States |
| Cancer Center of Paoli Memorial Hospital | Paoli | Pennsylvania | 19301-1792 | United States |
| Geisinger Medical Group - Scenery Park | State College | Pennsylvania | 16801 | United States |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| CCOP - Main Line Health | Wynnewood | Pennsylvania | 19096 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Kent County Memorial Hospital | Warwick | Rhode Island | 02886 | United States |
| AnMed Cancer Center | Anderson | South Carolina | 29621 | United States |
| Roper St. Francis Cancer Center at Roper Hospital | Charleston | South Carolina | 29401 | United States |
| Cancer Centers of the Carolinas - Easley | Easley | South Carolina | 29640 | United States |
| McLeod Regional Medical Center | Florence | South Carolina | 29501 | United States |
| Bon Secours St. Francis Health System | Greenville | South Carolina | 29601 | United States |
| Cancer Centers of the Carolinas - Faris Road | Greenville | South Carolina | 29605 | United States |
| Cancer Centers of the Carolinas - Grove Commons | Greenville | South Carolina | 29605 | United States |
| Greenville Hospital Cancer Center | Greenville | South Carolina | 29605 | United States |
| Self Regional Cancer Center at Self Regional Medical Center | Greenwood | South Carolina | 29646 | United States |
| Cancer Centers of the Carolinas - Greer Medical Oncology | Greer | South Carolina | 29650 | United States |
| Carolina Blood and Cancer Care Associates, PA | Lancaster | South Carolina | 29720 | United States |
| Carolina Blood and Cancer Care | Rock Hill | South Carolina | 29732 | United States |
| Cancer Centers of the Carolinas - Seneca | Seneca | South Carolina | 29672 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Cancer Centers of the Carolinas - Spartanburg | Spartanburg | South Carolina | 29307 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport | Tennessee | 37662 | United States |
| Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia | 22401 | United States |
| Hematology-Oncology Associates of Fredericksburg, Incorporated | Fredericksburg | Virginia | 22408 | United States |
| Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville | Virginia | 24115 | United States |
| Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton | Virginia | 24273 | United States |
| Overlake Cancer Center at Overlake Hospital Medical Center | Bellevue | Washington | 98004 | United States |
| St. Joseph Cancer Center | Bellingham | Washington | 98225 | United States |
| Providence Centralia Hospital | Centralia | Washington | 98531-9027 | United States |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | United States |
| St. Francis Hospital | Federal Way | Washington | 98003 | United States |
| Cascade Cancer Center at Evergreen Hospital Medical Center | Kirkland | Washington | 98033 | United States |
| Providence St. Peter Hospital Regional Cancer Center | Olympia | Washington | 98506-5166 | United States |
| Good Samaritan Cancer Center | Puyallup | Washington | 98372 | United States |
| CCOP - Virginia Mason Research Center | Seattle | Washington | 98101 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Pacific Medical Center | Seattle | Washington | 98104 | United States |
| Franciscan Cancer Center at St. Joseph Medical Center | Tacoma | Washington | 98405-3004 | United States |
| Allenmore Hospital | Tacoma | Washington | 98405 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405 | United States |
| MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| St. Clare Hospital | Tacoma | Washington | 98499 | United States |
| Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington | West Virginia | 25701 | United States |
| St. Mary's Regional Cancer Center at St. Mary's Medical Center | Huntington | West Virginia | 25702 | United States |
| Langlade Memorial Hospital | Antigo | Wisconsin | 54409 | United States |
| Fox Valley Hematology and Oncology - East Grant Street | Appleton | Wisconsin | 54911-3496 | United States |
| Marshfield Clinic - Chippewa Center | Chippewa Falls | Wisconsin | 54729 | United States |
| Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire | Wisconsin | 54701 | United States |
| Central Wisconsin Cancer Program at Agnesian HealthCare | Fond du Lac | Wisconsin | 54935 | United States |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54301-3526 | United States |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin | 54303 | United States |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin | 54303 | United States |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | United States |
| Mercy Regional Cancer Center | Janesville | Wisconsin | 53547 | United States |
| Franciscan Skemp Healthcare - La Crosse Campus | La Crosse | Wisconsin | 54601 | United States |
| Gundersen Lutheran Center for Cancer and Blood | La Crosse | Wisconsin | 54601 | United States |
| Holy Family Memorial Medical Center Cancer Care Center | Manitowoc | Wisconsin | 54221-1450 | United States |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | United States |
| Columbia Saint Mary's Hospital - Ozaukee | Mequon | Wisconsin | 53097 | United States |
| Columbia-Saint Mary's Cancer Care Center | Milwaukee | Wisconsin | 53211 | United States |
| Marshfield Clinic - Lakeland Center | Minocqua | Wisconsin | 54548 | United States |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin | 54154 | United States |
| All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine | Wisconsin | 53405 | United States |
| Ministry Medical Group at Saint Mary's Hospital | Rhinelander | Wisconsin | 54501 | United States |
| St. Nicholas Hospital | Sheboygan | Wisconsin | 53081 | United States |
| Marshfield Clinic at Saint Michael's Hospital | Stevens Point | Wisconsin | 54481 | United States |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | United States |
| University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau | Wisconsin | 54401 | United States |
| Oncology Alliance, SC - Milwaukee - West | Wauwatosa | Wisconsin | 53226 | United States |
| Marshfield Clinic - Weston Center | Weston | Wisconsin | 54476 | United States |
| Riverview UW Cancer Center at Riverview Hospital | Wisconsin Rapids | Wisconsin | 54494 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
| San Juan City Hospital | San Juan | 00936 | Puerto Rico |
Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy). |
| FG002 | Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post) | Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy). |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Calcium Gluconate + Magnesium Sulfate (Pre and Post) | Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).>> >> calcium gluconate: Given IV>> >> magnesium sulfate: Given IV>> >> oxaliplatin |
| BG001 | Placebo (Pre and Post) | Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> placebo: Given IV>> >> oxaliplatin |
| BG002 | Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post) | Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> calcium gluconate: Given IV>> >> magnesium sulfate: Given IV>> >> placebo: Given IV>> >> >> >>> oxaliplatin |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensory Area Under the Curve(AUC) Score. Oxaliplatin-induced Sensory Neuropathy as Repeatedly Measured by the EORTC QLQ-CIPN20 Sensory Subscale During Chemotherapy | The oxaliplatin-induced sensory neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) sensory subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 sensory subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 sensory subscale as the primary endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received. | All enrolled patients with Baseline and more than 1 cycle of Sensory data. | Posted | Mean | Standard Deviation | score on a scale | Up to 18 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve (AUC) of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Autonomic Neuropathy Subscale Scores | The oxaliplatin-induced autonomic neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) autonomic subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN autonomic subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 autonomic subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 autonomic subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received. | All patients with Baseline and more than one cycle of EORTC CIPN-20 Autonomic data. | Posted | Mean | Standard Deviation | score on a scale | Up to 18 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve (AUC) of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Motor Neuropathy Subscale Scores | The oxaliplatin-induced motor neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) motor neuropathy subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN motor neuropathy subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 motor neuropathy subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 motor neuropathy subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received. | All patients with at least baseline and more than 1 cycle of Motor Neuropathy data. | Posted | Mean | Standard Deviation | AUC QLQ-CIPN20 Motor Neuropathy Score | Up to 18 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Experiencing Grade 2+ and Grade 3+ Chronic Cumulative Neurotoxicity. | Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event. | All patients that under went at least one cycle of treatment and were analyzed for chronic cumulative neurotoxicity (NCI CTCAE version 4.0 and oxaliplatin-specific neurotoxicity scale) during and after chemotherapy | Posted | Number | percentage of patients | Up to 18 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Onset of Grade 2+ and Grade 3+ Chronic Cumulative Neurotoxicity and the Duration of the Chronic Cumulative Neurotoxicity During and After Chemotherapy | Time to onset of grade 2+ and grade 3+ chronic cumulative neurotoxicity, the duration of the chronic cumulative neurotoxicity during and after the adjuvant oxaliplatin-based chemotherapy. Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event. | Posted | Median | Inter-Quartile Range | Days | Up to 18 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Oxaliplatin Doses That Can be Administered Without Dose-limiting Chronic Neurotoxicity | A patient has a dose-limiting chronic neurotoxicity when they discontinue oxaliplatin-based chemotherapy because of neurotoxicity. | All patients that discontinued treatment. | Posted | Mean | Standard Deviation | Doses | Up to 18 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Discontinuing Oxaliplatin-based Chemotherapy Because of Neurotoxicity | All patients that received treatment. | Posted | Number | percentage of patients | Up to 18 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Acute Neuropathy Associated With Oxaliplatin | This is the percent of patients who scored >=50 in all sequences of all cycles by arm for side effect Q1: Sensitivity to touching cold. This is a> repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN subscale will be calculated by standard scoring algorithm and converted to 0-100 scale. Where 0 is no sensitivity and 100 is as bad as it can be. | Posted | Number | percentage of patients | Up to 18 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Calcium Gluconate and Magnesium Sulfate-induced Adverse Events as Measured by CTCAE Version 4.0 | Posted | Number | Number of reported Adverse Events | Up to 18 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve (AUC) of Patient-reported Quality of Life (QOL) as Measured by the Supplemental QOL Questionnaire | This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The supplemental quality of life (QOL) subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) . This AUC will be prorated by the number of chemotherapy cycles patients received. | All patients that had at least one cycle of treatment and submitted a patient-reported quality of life (QOL) as measured by the supplemental QOL questionnaire | Posted | Mean | Standard Deviation | score on a scale | Up to 18 months |
|
3 years
This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for adverse event monitoring and reporting. The CTCAE version 4.0 can be accessed from the CTEP home page (http://ctep.cancer.gov).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcium Gluconate + Magnesium Sulfate (Pre and Post) | oxaliplatin | 13 | 117 | 107 | 117 | ||
| EG001 | Placebo (Pre and Post) | oxaliplatin | 9 | 119 | 108 | 119 | ||
| EG002 | Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post) | oxaliplatin | 8 | 116 | 105 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Transient ischemic attacks | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 12 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Gastrointestinal disorders - Oth spec | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Ileal obstruction | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Rectal mucositis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Typhlitis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | MedDRA 12 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Anorectal infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Bladder infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Bronchitis(unknown ANC) | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Infections and infestations - Oth spec | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Hemoglobin increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| INR increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Weight gain | Investigations | MedDRA 12 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Dysesthesia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Stroke | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Renal and urinary disorders - Oth spec | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Bronchial stricture | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Laryngopharyngeal dysesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrm | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Skin and subcut tissue disord - Oth spec | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Surgical and medical proced - Oth spec | Surgical and medical procedures | MedDRA 12 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Superficial thrombophlebitis | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Vascular disorders - Other, specify | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Loprinzi, M.D. | Mayo Clinic | (507) 284-3731 | cloprinzi@mayo.edu |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D020258 | Neurotoxicity Syndromes |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002125 | Calcium Gluconate |
| D008278 | Magnesium Sulfate |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D005942 | Gluconates |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Male |
|
| United States |
|
| Two-sample t-tests or Wilcoxon rank-sum tests will be used>> to compare the AUC of CIPN sensory subscale between each of the two schedules of>> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory>> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory>> subscale scores from the AUC or incorporate them as a covariate in generalized linear>> regression model. | Wilcoxon (Mann-Whitney) | .29 | Non-Inferiority or Equivalence (legacy) | Two-sample t-tests or Wilcoxon rank-sum tests will be used as in>> primary analysis. |
| OG001 |
| Placebo (Pre and Post) |
Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).> >> > >> placebo: Given IV> >> > >> oxaliplatin |
| OG002 | Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post) | Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).> >> > >> calcium gluconate: Given IV> >> > >> magnesium sulfate: Given IV> >> > >> placebo: Given IV> >> > >> oxaliplatin |
|
|
|
| OG001 |
| Placebo (Pre and Post) |
Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> placebo: Given IV>> >> oxaliplatin |
| OG002 | Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post) | Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> calcium gluconate: Given IV>> >> magnesium sulfate: Given IV>> >> placebo: Given IV>> >> oxaliplatin |
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| OG002 | Arm III | Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).> >> > >> calcium gluconate: Given IV> >> > >> magnesium sulfate: Given IV> >> > >> placebo: Given IV> >> > >> oxaliplatin |
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