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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA032102 | U.S. NIH Grant/Contract | View source | |
| S0356 | Other Identifier | SWOG |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and fluorouracil may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving oxaliplatin together with fluorouracil and radiation therapy works in treating patients who are undergoing surgery for stage II or stage III cancer of the esophagus or gastroesophageal junction.
OBJECTIVES:
Primary
Secondary
Exploratory Analyses (subject to funding availability)
OUTLINE: This is a multicenter study.
Treatment continues in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 45-85 patients will be accrued for this study within 17-21 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemo Plus RT, Surgery, Chemo | Experimental | neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorouracil | Drug | Before surgery: 180 mg/m2/day by 24-hour infusion days 8 through 43. After surgery:180 mg/m2/day by 24-hour infusion days 1 through 36. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response | Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded. | 10-16 weeks after beginning study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Only adverse events that are possibly, probably or definitely related to study drug are reported. | Up to 3 years |
| Overall Survival |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed primary adenocarcinoma of the thoracic esophagus or gastroesophageal junction
Clinical stage II or III disease by CT scan or MRI
Measurable or non-measurable disease by x-ray, scanning, or physical examination
No celiac axis nodes ≥ 1.5 cm
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence P. Leichman, MD | Desert Regional Medical Center Comprehensive Cancer Center | Study Chair |
| Charles R. Thomas, MD | OHSU Knight Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36652-2144 | United States | ||
| Providence Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Leichman L, Goldman BH, Benedetti JK, et al.: Oxaliplatin (OXP) plus protracted infusion 5-fluorouracil (PIFU) and external beam radiation (EBRT) prior to surgery (S) for potentially curable esophageal adenocarcinoma (EA): A Southwest Oncology Group (SWOG) phase II trial with molecular correlates (S0356). [Abstract] J Clin Oncol 27 (Suppl 15): A-4513, 2009. | ||
| 22025151 | Derived | Leichman LP, Goldman BH, Bohanes PO, Lenz HJ, Thomas CR, Billingsley KG, Corless CL, Iqbal S, Gold PJ, Benedetti JK, Danenberg KD, Blanke CD. S0356: a phase II clinical and prospective molecular trial with oxaliplatin, fluorouracil, and external-beam radiation therapy before surgery for patients with esophageal adenocarcinoma. J Clin Oncol. 2011 Dec 1;29(34):4555-60. doi: 10.1200/JCO.2011.36.7490. Epub 2011 Oct 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemo Plus RT, Surgery, Chemo |
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| oxaliplatin | Drug | Before surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29. After surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29. |
|
|
| conventional surgery | Procedure | The surgical technique will depend upon the location and extent of tumor and individual surgeon preference. |
|
| radiation therapy | Radiation | Starting Day 8, patients will be treated 5 days/week at 180 centigray (cGy)/day times 25 fractions to a total dose of 4,500 cGy. |
|
Measured from time of registration to death, or last contact date
| 0-5 years |
| Progression-free Survival | measured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date. | 0-3 years |
| Anchorage |
| Alaska |
| 99508 |
| United States |
| Highlands Oncology Group - Springdale | Bentonville | Arkansas | 72712 | United States |
| East Bay Radiation Oncology Center | Castro Valley | California | 94546 | United States |
| Eden Medical Center | Castro Valley | California | 94546 | United States |
| Valley Medical Oncology Consultants - Castro Valley | Castro Valley | California | 94546 | United States |
| Valley Medical Oncology | Fremont | California | 94538 | United States |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90089-9181 | United States |
| Highland General Hospital | Oakland | California | 94602 | United States |
| Alta Bates Summit Medical Center - Summit Campus | Oakland | California | 94609 | United States |
| Bay Area Breast Surgeons, Incorporated | Oakland | California | 94609 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609 | United States |
| Larry G Strieff MD Medical Corporation | Oakland | California | 94609 | United States |
| Tom K Lee, Incorporated | Oakland | California | 94609 | United States |
| Desert Regional Medical Center Comprehensive Cancer Center | Palm Springs | California | 92262 | United States |
| Valley Care Medical Center | Pleasanton | California | 94588 | United States |
| Valley Medical Oncology Consultants - Pleasanton | Pleasanton | California | 94588 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| Doctors Medical Center - San Pablo Campus | San Pablo | California | 94806 | United States |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | 31403-3089 | United States |
| Saint Anthony's Hospital at Saint Anthony's Health Center | Alton | Illinois | 62002 | United States |
| Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois | 62526 | United States |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Good Samaritan Regional Health Center | Mount Vernon | Illinois | 62864 | United States |
| Regional Cancer Center at Memorial Medical Center | Springfield | Illinois | 62781-0001 | United States |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| Reid Hospital & Health Care Services | Richmond | Indiana | 47374 | 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 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | United States |
| Southwest Medical Center | Liberal | Kansas | 67901 | United States |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | United States |
| Olathe Cancer Center | Olathe | Kansas | 66061 | United States |
| Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas, PA - Salina | Salina | Kansas | 67042 | United States |
| Cotton-O'Neil Cancer Center | Topeka | Kansas | 66606 | United States |
| St. Francis Comprehensive Cancer Center | Topeka | Kansas | 66606 | 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 |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | 67156 | United States |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | United States |
| Boston University Cancer Research Center | Boston | Massachusetts | 02118 | United States |
| Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | 49017 | United States |
| Mecosta County Medical Center | Big Rapids | Michigan | 49307 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | 49503 | United States |
| Metro Health Hospital | Grand Rapids | Michigan | 49506 | United States |
| Holland Community Hospital | Holland | Michigan | 49423 | United States |
| Hackley Hospital | Muskegon | Michigan | 49442 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | United States |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau | Missouri | 63701 | United States |
| St. John's Regional Medical Center | Joplin | Missouri | 64804 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65802 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| CCOP - St. Louis-Cape Girardeau | St Louis | Missouri | 63141 | United States |
| David C. Pratt Cancer Center at St. John's Mercy | St Louis | Missouri | 63141 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59101 | United States |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare Cancer Care Services | Billings | Montana | 59101 | 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 |
| Frontier Cancer Center | Great Falls | Montana | 59405 | 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 |
| 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 |
| Community Medical Center | Missoula | Montana | 59801 | United States |
| Guardian Oncology and Center for Wellness | Missoula | Montana | 59804 | 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 |
| Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney | Nebraska | 68848-1990 | United States |
| Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown | New York | 10940-4199 | United States |
| Randolph Hospital | Asheboro | North Carolina | 27203-5400 | United States |
| Mission Hospitals - Memorial Campus | Asheville | North Carolina | 28801 | United States |
| Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro | North Carolina | 27403-1198 | United States |
| Annie Penn Cancer Center | Reidsville | North Carolina | 27320 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | United States |
| McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267 | 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 |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | United States |
| Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| Clinton Memorial Hospital | Wilmington | Ohio | 45177 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| AnMed Cancer Center | Anderson | South Carolina | 29621 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | 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 |
| Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport | Tennessee | 37662 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| American Fork Hospital | American Fork | Utah | 84003 | United States |
| Sandra L. Maxwell Cancer Center | Cedar City | Utah | 84720 | United States |
| Logan Regional Hospital | Logan | Utah | 84321 | United States |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray | Utah | 84157 | United States |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| LDS Hospital | Salt Lake City | Utah | 84103 | United States |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | United States |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | United States |
| Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton | Virginia | 24273 | United States |
| St. Joseph Cancer Center | Bellingham | Washington | 98225 | United States |
| Olympic Hematology and Oncology | Bremerton | Washington | 98310 | United States |
| Columbia Basin Hematology | Kennewick | Washington | 99336 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98104 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Minor and James Medical, PLLC | Seattle | Washington | 98104 | United States |
| Veterans Affairs Medical Center - Seattle | Seattle | Washington | 98108 | United States |
| Group Health Central Hospital | Seattle | Washington | 98112 | United States |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | 98122-4307 | United States |
| Polyclinic First Hill | Seattle | Washington | 98122 | United States |
| University Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| Cancer Care Northwest - Spokane South | Spokane | Washington | 99202 | United States |
| Rockwood Clinic Cancer Treatment Center | Spokane | Washington | 99204-2967 | United States |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801-2028 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
| Eligible |
|
| Eligible and Began Protocol Therapy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chemo Plus RT, Surgery, Chemo | Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Of eligible patients | Median | Full Range | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Pathological Complete Response | Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded. | Eligible patients | Posted | Number | participants | 10-16 weeks after beginning study treatment |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Only adverse events that are possibly, probably or definitely related to study drug are reported. | Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any Common Terminology Criteria for Adverse Events (CTCAE) v3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. | Posted | Number | Participants | Up to 3 years |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | Measured from time of registration to death, or last contact date | eligible patients | Posted | Median | 95% Confidence Interval | months | 0-5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival | measured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date. | eligible patients | Posted | Median | 95% Confidence Interval | months | 0-3 years |
|
|
Up to 3 years
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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 | Chemo Plus RT, Surgery, Chemo | Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin | 7 | 93 | 93 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac-ischemia/infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pericardial effusion (non-malignant) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| SVT and nodal arrhythmia - Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Typhlitis (cecal inflammation) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Inf (clin/microbio) w/Gr 3-4 neuts - Lung | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Inf w/normal ANC or Gr 1-2 neutrophils - Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac troponin I (cTnI) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Adult respiratory distress syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| SVT and nodal arrhythmia - Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| SVT and nodal arrhythmia - Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Distention/bloating, abdominal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastritis (including bile reflux gastritis) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastrointestinal-Other (Specify) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) - Esophagus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symp) - Esophagus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symp) - Oral cav | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Esophagus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stricture/stenosis (incl anastomotic), Esophagus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever in absence of neutropenia, ANC lt1.0x10e9/L | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Chest/thorax NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-Other (Specify) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Inf w/normal ANC or Gr 1-2 neutrophils - Lung | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Inf w/normal ANC or Gr 1-2 neutrophils - Wound | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Leak (including anastomotic), GI - Esophagus | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Laboratory-Other (Specify) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste alteration (dysgeusia) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory-Other (Specify) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | SWOG Statistical Center | 206-667-4623 |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Title | Denominators | Categories |
|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|