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| ID | Type | Description | Link |
|---|---|---|---|
| E7296 | Other Identifier | Eastern Cooperative Oncology Group | |
| U10CA023318 | U.S. NIH Grant/Contract | View source | |
| NCT00003298 | Registry Identifier | National Cancer Institute |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy use 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. Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells. E7296 was conducted to study neoadjuvant chemotherapy and postoperative chemoradiation therapy in patients diagnosed with high-risk gastric cancer using a new neoadjuvant regimen: paclitaxel plus cisplatin. It was hypothesized that this new neoadjuvant chemotherapy followed by surgery and chemoradiation therapy would be well tolerated and would have a high curative resection rate.
OBJECTIVES:
Primary objective: To evaluate the tolerability and toxicity of neoadjuvant cisplatin plus paclitaxel and postoperative chemoradiation therapy with fluorouracil plus leucovorin calcium in patients with high-risk gastric cancer.
Secondary objectives: To assess the pathologic response of gastric tumors to neoadjuvant cisplatin plus paclitaxel chemotherapy, and preliminarily assess the patterns of failure and disease free and overall survival.
OUTLINE: Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment. Patients are followed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter.
PROJECTED ACCRUAL: Approximately 30-42 patients will be accrued over 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | Cisplatin was administered as part of the neoadjuvant regimen. It was given at a dose of 75 mg/m² via IV over approximately one hour, on day 1 of each cycle. Three cycles were given. |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3 or Higher Toxicity Incidence on Step 1 | Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients. | assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total) |
| Measure | Description | Time Frame |
|---|---|---|
| Best Confirmed Response to Neoadjuvant Therapy | Response was based on pathology at surgery. A patient achieved complete response if no gross or microscopic tumor were identified with the surgical specimen and nodal tissue. Stable response was defined as a response that did not qualify as complete response or progressive disease (PD), where PD indicated metastatic spread. Best confirmed response rate was defined as the proportion of patients with complete response (CR). A patient was considered unevaluable if the patient did not have surgery, the pathologist did not examine at least 15 lymph nodes, or the pathology report was unavailable. |
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Inclusion Criteria:
Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
Localized cancer that is potentially curable by surgery (T2, N1-2, M0 or T3-4, any N, M0)
No metastatic cancer to the ovaries
Age: 18 and over
Easter Cooperative Oncology Group (ECOG) performance status 0-2
White blood cell (WBC) count at least 4,000 cells/mm3
Platelet count at least 150,000/mm3
Bilirubin less than 2 mg/dL
Creatinine no greater than 1.5 mg/dL
Creatinine clearance greater than 50 mL/min
Caloric intake must be at least 1500 kcal/day
No prior history of cancer within the past 5 years except for basal cell carcinoma of the skin or in situ carcinoma of the cervix
No prior radiation therapy, except for skin cancer
Fertile patients must use adequate contraception
Met criteria for re-registration after surgery
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David I. Rosenthal, MD | Abramson Cancer Center at Penn Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Colorado Cancer Research Program, Inc. | Denver | Colorado | 80209-5031 | United States | ||
| Emory University Hospital - Atlanta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23293700 | Result | Chakravarthy AB, Catalano PJ, Mondschein JK, Rosenthal DI, Haller DG, Whittington R, Spitz FR, Wagner H, Sigurdson ER, Tschetter LK, Bayer GK, Mulcahy MF, Benson AB. Phase II Trial of Paclitaxel/Cisplatin Followed by Surgery and Adjuvant Radiation Therapy and 5-Fluorouracil/Leucovorin for Gastric Cancer (ECOG E7296). Gastrointest Cancer Res. 2012 Nov;5(6):191-7. |
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E7296 was activated on February 25, 1999, accrued its first patient on June 1, 1999, and terminated on March 18, 2002 with a final accrual of 39 patients (accrual goal: 42 patients) enrolled by 13 ECOG affiliated institutions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Arm | Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Step 1 (Neoadjuvant Therapy) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
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|
| fluorouracil | Drug | Postoperative regimen 5-FU, along with Leucovorin, was given by IV bolus, with 5-FU given immediately after the Leucovorin |
|
|
| leucovorin calcium | Drug | Both 5-FU and Leucovorin will be given via IV bolus, with Leucovorin given immediately before 5-FU. |
|
|
| paclitaxel | Drug | Paclitaxel was administered as part of the neoadjuvant regimen. It was given at a dose of 175 mg/m² as a 3 hour continuous intravenous infusion on day 1. Three cycles were given. |
|
|
| surgery | Procedure | The surgical procedure performed involved a radical subtotal or total gastrectomy. A complete surgical resection was required |
|
| radiation therapy | Radiation | Concomitant chemotherapy and radiation therapy course: 5-FU 400 mg/m²/day + Leucovorin 20 mg/m²/day on days 1-4 of week one and days 1-3 of week 5 of XRT. Combined chemotherapy and radiation therapy were to begin 4 weeks after day 1 of the initial course of chemotherapy |
|
| Assessed at surgery time (surgery performed during week 8-10 after registration to the study) |
| Overall Survival | Overall survival was defined as the time from registration to death, where a subject was censored on date of last record alive. | assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10 |
| Progression Free Survival | Progression-free survival (PFS) was defined as time from registration until progression, recurrence, or death, whichever occurred first. If date of death occurred beyond three months from the date of last disease assessment, then PFS was censored at date of last disease assessment. Patients who were alive and progression-free were censored at the date of last disease evaluation. | assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10 |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| Veterans Affairs Medical Center - Lakeside Chicago | Chicago | Illinois | 60611 | United States |
| CCOP - Evanston | Evanston | Illinois | 60201 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana | 46202 | United States |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | 52403-1206 | United States |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | United States |
| New England Medical Center Hospital | Boston | Massachusetts | 02111 | United States |
| CCOP - Ann Arbor Regional | Ann Arbor | Michigan | 48106 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68131 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962-1956 | United States |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Raritan Bay Medical Center | Perth Amboy | New Jersey | 08861 | United States |
| Somerset Medical Center | Somerville | New Jersey | 08876 | United States |
| University of Rochester Cancer Center | Rochester | New York | 14642 | United States |
| Albert Einstein Comprehensive Cancer Center | The Bronx | New York | 10461 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio | 43623-3456 | United States |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104-4283 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | Nashville | Tennessee | 37212 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| CCOP - Marshfield Medical Research and Education Foundation | Marshfield | Wisconsin | 54449 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin | 53295 | United States |
| Eligible and Treated |
|
| Complete 3 Cycles of Neoadjuvant Therapy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Surgery |
|
|
| Re-register to Step 2 After Surgery |
|
|
| Step 2 (Adjuvant Therapy) |
|
|
Eligible and treated in step 1
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Arm | Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Best Confirmed Response to Neoadjuvant Therapy | Response was based on pathology at surgery. A patient achieved complete response if no gross or microscopic tumor were identified with the surgical specimen and nodal tissue. Stable response was defined as a response that did not qualify as complete response or progressive disease (PD), where PD indicated metastatic spread. Best confirmed response rate was defined as the proportion of patients with complete response (CR). A patient was considered unevaluable if the patient did not have surgery, the pathologist did not examine at least 15 lymph nodes, or the pathology report was unavailable. | Eligible and treated patients on step 1. Since no patient had a complete response in the study, one-sided 95% confidence interval was provided here. | Posted | Number | 95% Confidence Interval | percentage of participants | Assessed at surgery time (surgery performed during week 8-10 after registration to the study) |
|
|
| |||||||||||||||||||||||||
| Primary | Grade 3 or Higher Toxicity Incidence on Step 1 | Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients. | eligible and treated patients on step 1 | Posted | Number | 95% Confidence Interval | percentage of participants | assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time from registration to death, where a subject was censored on date of last record alive. | eligible and treated patients on step 1 | Posted | Median | 90% Confidence Interval | years | assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10 |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Progression-free survival (PFS) was defined as time from registration until progression, recurrence, or death, whichever occurred first. If date of death occurred beyond three months from the date of last disease assessment, then PFS was censored at date of last disease assessment. Patients who were alive and progression-free were censored at the date of last disease evaluation. | eligible and treated patients on step 1 | Posted | Median | 90% Confidence Interval | years | assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10 |
|
|
Assessed every cycle while on treatment and for 30 days after the end of treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Step 1(Neoadjuvant Therapy) | Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. | 25 | 38 | 38 | 38 | ||
| EG001 | Step 2 (Adjuvant Therapy) | After neoadjuvant therapy, patients undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment. | 6 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylaxis | Immune system disorders | CTCAE 2.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 2.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 2.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE 2.0 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE 2.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE 2.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCAE 2.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Infection with grade 3 or 4 neutropenia | Infections and infestations | CTCAE 2.0 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE 2.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hearing impaired | Ear and labyrinth disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE 2.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 2.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 2.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE 2.0 | Systematic Assessment |
| |
| Cardiac disorders - Other | Cardiac disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE 2.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Nail loss | Skin and subcutaneous tissue disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE 2.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE 2.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE 2.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE 2.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE 2.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Watering eyes | Eye disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE 2.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE 2.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study statistician | ECOG-ACRIN Statistical Office | 617-632-3012 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D010984 | Platinum |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D017239 | Paclitaxel |
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
Not provided
Not provided
| Reason unknown |
|
| Ineligible due to tumor staging |
|
| Excessive complication |
|
| Withdrawal by Subject |
|
|
|
|
|