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Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00052910
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : July 17, 2018
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Esophageal Cancer
Gastric Cancer
Interventions Drug: cisplatin
Drug: epirubicin hydrochloride
Drug: fluorouracil
Drug: leucovorin calcium
Radiation: radiation therapy
Enrollment 546
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (5-FU/LV) Arm II (ECF)
Hide Arm/Group Description Patients receive leucovorin calcium (LV) IV (20 mg/m^2 per day) and fluorouracil (5-FU) IV (425 mg/m^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3. Patients receive epirubicin IV (50 mg/m^2) over 3-15 minutes and cisplatin IV (60 mg/m^2) over 1 hour on day 1 and 5-FU IV (200 mg/m^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
Period Title: Overall Study
Started 280 266
Completed 280 266
Not Completed 0 0
Arm/Group Title Arm I (5-FU/LV) Arm II (ECF) Total
Hide Arm/Group Description Patients receive leucovorin calcium (LV) IV (20 mg/m^2 per day) and fluorouracil (5-FU) IV (425 mg/m^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3. Patients receive epirubicin IV (50 mg/m^2) over 3-15 minutes and cisplatin IV (60 mg/m^2) over 1 hour on day 1 and 5-FU IV (200 mg/m^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses. Total of all reporting groups
Overall Number of Baseline Participants 280 266 546
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 280 participants 266 participants 546 participants
59
(23 to 81)
58
(29 to 83)
58.6
(23 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 266 participants 546 participants
Female
87
  31.1%
88
  33.1%
175
  32.1%
Male
193
  68.9%
178
  66.9%
371
  67.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 280 participants 266 participants 546 participants
Canada 21 17 38
United States 259 249 508
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time Frame From study enrollment until death from any cause; up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (5-FU/LV) Arm II (ECF)
Hide Arm/Group Description:
Patients receive leucovorin calcium (LV) IV (20 mg/m^2 per day) and fluorouracil (5-FU) IV (425 mg/m^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
Patients receive epirubicin IV (50 mg/m^2) over 3-15 minutes and cisplatin IV (60 mg/m^2) over 1 hour on day 1 and 5-FU IV (200 mg/m^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
Overall Number of Participants Analyzed 280 266
Median (95% Confidence Interval)
Unit of Measure: years
3.6
(2.8 to 4.9)
3.5
(2.5 to 5.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (5-FU/LV), Arm II (ECF)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.79 to 1.24
Estimation Comments Adjusted Hazard Ratio, ECF vs 5-FU/LV
2.Secondary Outcome
Title Disease Free Survival
Hide Description Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier.
Time Frame From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (5-FU/LV) Arm II (ECF)
Hide Arm/Group Description:
Patients receive leucovorin calcium (LV) IV (20 mg/m^2 per day) and fluorouracil (5-FU) IV (425 mg/m^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
Patients receive epirubicin IV (50 mg/m^2) over 3-15 minutes and cisplatin IV (60 mg/m^2) over 1 hour on day 1 and 5-FU IV (200 mg/m^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
Overall Number of Participants Analyzed 280 266
Median (95% Confidence Interval)
Unit of Measure: years
2.7
(1.9 to 3.8)
2.3
(1.5 to 3.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (5-FU/LV), Arm II (ECF)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.83 to 1.28
Estimation Comments Adjusted Hazard Ratio, ECF vs 5-FU/LV
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (5-FU/LV) Arm II (ECF)
Hide Arm/Group Description Patients receive leucovorin calcium (LV) IV (20 mg/m^2 per day) and fluorouracil (5-FU) IV (425 mg/m^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3. Patients receive epirubicin IV (50 mg/m^2) over 3-15 minutes and cisplatin IV (60 mg/m^2) over 1 hour on day 1 and 5-FU IV (200 mg/m^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
All-Cause Mortality
Arm I (5-FU/LV) Arm II (ECF)
Affected / at Risk (%) Affected / at Risk (%)
Total   11/272 (4.04%)      5/251 (1.99%)    
Hide Serious Adverse Events
Arm I (5-FU/LV) Arm II (ECF)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   62/272 (22.79%)      42/251 (16.73%)    
Blood and lymphatic system disorders     
Blood disorder  1  2/272 (0.74%)  2 1/251 (0.40%)  1
Febrile neutropenia  1  7/272 (2.57%)  8 0/251 (0.00%)  0
Hemoglobin decreased  1  7/272 (2.57%)  7 8/251 (3.19%)  10
Hemolysis  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Transfusion: Platelets  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Cardiac disorders     
Arrhythmia supraventricular  1  2/272 (0.74%)  2 2/251 (0.80%)  2
Atrial tachycardia  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Cardiac disorder  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Edema  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Left ventricular failure  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Myocardial ischemia  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Pericardial effusion  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Sinus bradycardia  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Sinus tachycardia  1  2/272 (0.74%)  2 2/251 (0.80%)  2
Ventricular arrhythmia  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Eye disorders     
Diplopia  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Eye disorder  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Vision blurred  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  27/272 (9.93%)  29 9/251 (3.59%)  9
Ascites  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Colitis  1  5/272 (1.84%)  5 0/251 (0.00%)  0
Colonic obstruction  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Constipation  1  2/272 (0.74%)  2 3/251 (1.20%)  3
Diarrhea  1  31/272 (11.40%)  32 10/251 (3.98%)  11
Dyspepsia  1  2/272 (0.74%)  2 4/251 (1.59%)  4
Dysphagia  1  6/272 (2.21%)  6 1/251 (0.40%)  1
Dysphagia-esophageal related to radiation  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Esophagitis  1  5/272 (1.84%)  5 2/251 (0.80%)  2
Flatulence  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Gastrointestinal disorder  1  5/272 (1.84%)  5 2/251 (0.80%)  2
Ileus  1  0/272 (0.00%)  0 3/251 (1.20%)  3
Mucositis oral  1  26/272 (9.56%)  27 5/251 (1.99%)  6
Nausea  1  40/272 (14.71%)  41 19/251 (7.57%)  20
Rectal pain  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Vomiting  1  22/272 (8.09%)  24 15/251 (5.98%)  16
General disorders     
Chest pain  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Chills  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Death NOS  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Esophagus- Late RT Morbidity Scoring  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Fatigue  1  32/272 (11.76%)  35 25/251 (9.96%)  28
Fever  1  2/272 (0.74%)  2 2/251 (0.80%)  3
Heart- Late RT Morbidity Scoring  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Joint- Late RT Morbidity Scoring  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Lung-Late RT Morbidity Scoring  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Mucous membrane-Late RT Morbidity Scoring  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Pain  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Infections and infestations     
Catheter related infection  1  2/272 (0.74%)  2 4/251 (1.59%)  4
Infection  1  2/272 (0.74%)  2 1/251 (0.40%)  1
Infection with grade 3 or 4 neutropenia  1  3/272 (1.10%)  3 1/251 (0.40%)  1
Infection without neutropenia  1  4/272 (1.47%)  4 1/251 (0.40%)  1
Pneumonia  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Sepsis  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Injury, poisoning and procedural complications     
Dermatitis radiation  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Fracture  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Wound dehiscence  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Investigations     
Activated partial thromboplastin time prolonged  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Alanine aminotransferase increased  1  1/272 (0.37%)  1 2/251 (0.80%)  2
Alkaline phosphatase increased  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Amylase increased  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Aspartate aminotransferase increased  1  2/272 (0.74%)  2 2/251 (0.80%)  2
Blood bilirubin increased  1  3/272 (1.10%)  3 1/251 (0.40%)  1
Creatinine increased  1  7/272 (2.57%)  7 3/251 (1.20%)  3
INR increased  1  2/272 (0.74%)  2 1/251 (0.40%)  1
Laboratory test abnormal  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Leukocyte count decreased  1  24/272 (8.82%)  25 19/251 (7.57%)  21
Lymphocyte count decreased  1  5/272 (1.84%)  5 4/251 (1.59%)  5
Neutrophil count decreased  1  25/272 (9.19%)  26 20/251 (7.97%)  22
Platelet count decreased  1  14/272 (5.15%)  15 9/251 (3.59%)  10
Serum cholesterol increased  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Weight gain  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Weight loss  1  6/272 (2.21%)  6 7/251 (2.79%)  7
Metabolism and nutrition disorders     
Acidosis  1  2/272 (0.74%)  2 1/251 (0.40%)  1
Alkalosis  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Anorexia  1  27/272 (9.93%)  29 16/251 (6.37%)  18
Blood glucose increased  1  5/272 (1.84%)  5 3/251 (1.20%)  3
Dehydration  1  16/272 (5.88%)  16 9/251 (3.59%)  10
Serum albumin decreased  1  6/272 (2.21%)  6 2/251 (0.80%)  3
Serum calcium decreased  1  3/272 (1.10%)  3 4/251 (1.59%)  4
Serum glucose decreased  1  1/272 (0.37%)  1 2/251 (0.80%)  2
Serum magnesium decreased  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Serum phosphate decreased  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Serum potassium decreased  1  11/272 (4.04%)  12 3/251 (1.20%)  4
Serum sodium decreased  1  2/272 (0.74%)  2 1/251 (0.40%)  1
Serum sodium increased  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Back pain  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Muscle weakness  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Musculoskeletal disorder  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Nervous system disorders     
Depressed level of consciousness  1  1/272 (0.37%)  1 2/251 (0.80%)  2
Dizziness  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Dysgeusia  1  2/272 (0.74%)  2 1/251 (0.40%)  1
Headache  1  4/272 (1.47%)  4 0/251 (0.00%)  0
Intracranial hemorrhage  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Memory impairment  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Mini mental status examination abnormal  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Neurological disorder NOS  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Peripheral motor neuropathy  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Peripheral sensory neuropathy  1  6/272 (2.21%)  6 4/251 (1.59%)  4
Speech disorder  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Syncope  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Psychiatric disorders     
Confusion  1  2/272 (0.74%)  2 1/251 (0.40%)  1
Depression  1  2/272 (0.74%)  2 2/251 (0.80%)  3
Insomnia  1  1/272 (0.37%)  1 2/251 (0.80%)  2
Renal and urinary disorders     
Renal failure  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Urinary frequency  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Cough  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Dyspnea  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Dyspnea (shortness of breath)  1  2/272 (0.74%)  2 1/251 (0.40%)  1
Hiccups  1  0/272 (0.00%)  0 1/251 (0.40%)  2
Hypoxia  1  2/272 (0.74%)  2 1/251 (0.40%)  1
Pleural effusion  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Pleuritic pain  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Pneumonitis  1  4/272 (1.47%)  4 0/251 (0.00%)  0
Respiratory disorder  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Dry skin  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Hand-and-foot syndrome  1  7/272 (2.57%)  7 2/251 (0.80%)  2
Pruritus  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Rash desquamating  1  3/272 (1.10%)  3 0/251 (0.00%)  0
Sweating  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Vascular disorders     
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Hypotension  1  7/272 (2.57%)  8 4/251 (1.59%)  4
Thrombosis  1  1/272 (0.37%)  1 3/251 (1.20%)  3
1
Term from vocabulary, MedDRA 6
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (5-FU/LV) Arm II (ECF)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   258/272 (94.85%)      234/251 (93.23%)    
Blood and lymphatic system disorders     
Blood disorder  1  2/272 (0.74%)  4 1/251 (0.40%)  2
Febrile neutropenia  1  10/272 (3.68%)  11 8/251 (3.19%)  10
Hemoglobin decreased  1  80/272 (29.41%)  165 81/251 (32.27%)  180
Hemoglobin for leukemia studies  1  0/272 (0.00%)  0 2/251 (0.80%)  2
Hemolysis  1  2/272 (0.74%)  2 1/251 (0.40%)  1
Lymphatic disorder  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Thrombotic microangiopathy  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Transfusion: pRBCs  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Cardiac disorders     
Arrhythmia  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Arrhythmia supraventricular  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Cardiac disorder  1  0/272 (0.00%)  0 6/251 (2.39%)  6
Cardiac pain  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Conduction disorder  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Edema  1  5/272 (1.84%)  5 2/251 (0.80%)  2
Myocardial ischemia  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Palpitations  1  1/272 (0.37%)  2 0/251 (0.00%)  0
Pericarditis  1  1/272 (0.37%)  4 0/251 (0.00%)  0
Sinus bradycardia  1  1/272 (0.37%)  2 1/251 (0.40%)  1
Sinus tachycardia  1  4/272 (1.47%)  4 1/251 (0.40%)  1
Supraventricular tachycardia  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Ventricular tachycardia  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Ear and labyrinth disorders     
Ear disorder  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Ear pain  1  0/272 (0.00%)  0 1/251 (0.40%)  2
Hearing impaired  1  0/272 (0.00%)  0 3/251 (1.20%)  3
Hearing test abnormal  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Middle ear inflammation  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Tinnitus  1  0/272 (0.00%)  0 2/251 (0.80%)  2
Eye disorders     
Dry eye syndrome  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Eye disorder  1  3/272 (1.10%)  6 2/251 (0.80%)  3
Flashing vision  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Vision blurred  1  2/272 (0.74%)  3 1/251 (0.40%)  1
Watering eyes  1  2/272 (0.74%)  3 2/251 (0.80%)  2
Gastrointestinal disorders     
Abdominal distension  1  1/272 (0.37%)  1 2/251 (0.80%)  2
Abdominal pain  1  109/272 (40.07%)  186 94/251 (37.45%)  141
Ascites  1  1/272 (0.37%)  1 2/251 (0.80%)  2
Colitis  1  4/272 (1.47%)  5 0/251 (0.00%)  0
Constipation  1  37/272 (13.60%)  54 40/251 (15.94%)  59
Diarrhea  1  162/272 (59.56%)  313 120/251 (47.81%)  227
Dry mouth  1  4/272 (1.47%)  6 5/251 (1.99%)  6
Duodenal ulcer  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Dyspepsia  1  18/272 (6.62%)  24 21/251 (8.37%)  35
Dysphagia  1  24/272 (8.82%)  29 23/251 (9.16%)  37
Dysphagia-esophageal related to radiation  1  2/272 (0.74%)  2 1/251 (0.40%)  1
Ear, nose and throat examination abnormal  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Enteritis  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Esophageal pain  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Esophageal stenosis  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Esophagitis  1  11/272 (4.04%)  14 13/251 (5.18%)  15
Fistula of small intestine  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Flatulence  1  10/272 (3.68%)  13 4/251 (1.59%)  9
Gastric hemorrhage  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Gastric stenosis  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Gastric ulcer  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Gastritis  1  7/272 (2.57%)  8 7/251 (2.79%)  9
Gastrointestinal disorder  1  8/272 (2.94%)  9 7/251 (2.79%)  8
Hemorrhoids  1  1/272 (0.37%)  3 1/251 (0.40%)  1
Ileus  1  2/272 (0.74%)  2 2/251 (0.80%)  2
Malabsorption  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Mucositis due to radiation  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Mucositis oral  1  155/272 (56.99%)  248 107/251 (42.63%)  168
Nausea  1  192/272 (70.59%)  390 176/251 (70.12%)  425
Oral pain  1  4/272 (1.47%)  4 1/251 (0.40%)  1
Pancreatitis  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Proctitis  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Rectal bleeding/hematochezia  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Rectal hemorrhage  1  0/272 (0.00%)  0 1/251 (0.40%)  4
Salivary gland disorder  1  0/272 (0.00%)  0 2/251 (0.80%)  2
Small intestinal obstruction  1  0/272 (0.00%)  0 2/251 (0.80%)  2
Stomach pain  1  0/272 (0.00%)  0 3/251 (1.20%)  4
Vomiting  1  123/272 (45.22%)  191 120/251 (47.81%)  209
General disorders     
Bladder- Late RT Morbidity Scoring  1  0/272 (0.00%)  0 3/251 (1.20%)  3
Bone - Late RT Morbidity Scoring  1  0/272 (0.00%)  0 2/251 (0.80%)  2
Brain- Late RT Morbidity Scoring  1  1/272 (0.37%)  1 2/251 (0.80%)  2
Chest pain  1  5/272 (1.84%)  7 8/251 (3.19%)  10
Chills  1  3/272 (1.10%)  5 3/251 (1.20%)  4
Edema limbs  1  3/272 (1.10%)  3 7/251 (2.79%)  10
Esophagus- Late RT Morbidity Scoring  1  19/272 (6.99%)  63 19/251 (7.57%)  32
Facial pain  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Fatigue  1  201/272 (73.90%)  493 190/251 (75.70%)  503
Fever  1  10/272 (3.68%)  11 6/251 (2.39%)  6
Flu-like symptoms  1  1/272 (0.37%)  1 0/251 (0.00%)  0
General symptom  1  2/272 (0.74%)  2 3/251 (1.20%)  4
Heart- Late RT Morbidity Scoring  1  3/272 (1.10%)  4 4/251 (1.59%)  7
Ill-defined disorder  1  2/272 (0.74%)  2 1/251 (0.40%)  1
Joint- Late RT Morbidity Scoring  1  2/272 (0.74%)  2 1/251 (0.40%)  1
Kidney-Late RT Morbidity Scoring  1  3/272 (1.10%)  3 3/251 (1.20%)  6
Larynx-Late RT Morbidity Scoring  1  2/272 (0.74%)  2 1/251 (0.40%)  2
Liver-Late RT Morbidity Scoring  1  6/272 (2.21%)  17 4/251 (1.59%)  7
Localized edema  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Lung-Late RT Morbidity Scoring  1  8/272 (2.94%)  11 6/251 (2.39%)  14
Mucous membrane-Late RT Morbidity Scoring  1  3/272 (1.10%)  3 4/251 (1.59%)  5
Pain  1  19/272 (6.99%)  31 23/251 (9.16%)  32
Pericardial pain  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Radiation-Other(Specify,_____)  1  17/272 (6.25%)  24 11/251 (4.38%)  28
Salivary glands-Late RT Morbidity Scoring  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Skin-Late RT Morbidity Scoring  1  6/272 (2.21%)  6 3/251 (1.20%)  3
Small/Large intestine-Late RT Morbidity Scoring  1  12/272 (4.41%)  16 12/251 (4.78%)  23
Subcutaneous tissue-Late RT Morbidity Scoring  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Hepatobiliary disorders     
Hepatobiliary disease  1  3/272 (1.10%)  6 1/251 (0.40%)  1
Portal hypertension  1  1/272 (0.37%)  2 0/251 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Infections and infestations     
Abdominal infection  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Bladder infection  1  2/272 (0.74%)  4 0/251 (0.00%)  0
Bronchitis  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Catheter related infection  1  1/272 (0.37%)  2 5/251 (1.99%)  6
Device related infection  1  1/272 (0.37%)  2 2/251 (0.80%)  2
Esophageal infection  1  1/272 (0.37%)  1 2/251 (0.80%)  2
Infection  1  10/272 (3.68%)  13 1/251 (0.40%)  1
Infection with grade 3 or 4 neutropenia  1  4/272 (1.47%)  4 2/251 (0.80%)  3
Infection with unknown ANC  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Infection without neutropenia  1  6/272 (2.21%)  6 7/251 (2.79%)  7
Infectious colitis  1  3/272 (1.10%)  3 0/251 (0.00%)  0
Opportunistic infection  1  0/272 (0.00%)  0 2/251 (0.80%)  3
Paranasal sinus infection  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Penile infection  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Peripheral nerve infection  1  0/272 (0.00%)  0 2/251 (0.80%)  3
Pneumonia  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Sepsis  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Sinusitis  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Skin infection  1  1/272 (0.37%)  1 2/251 (0.80%)  3
Stoma site infection  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Tooth infection  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Ureteritis  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Urinary tract infection  1  0/272 (0.00%)  0 2/251 (0.80%)  2
Wound infection  1  2/272 (0.74%)  2 2/251 (0.80%)  3
Wound-infectious  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Injury, poisoning and procedural complications     
Dermatitis radiation  1  23/272 (8.46%)  26 16/251 (6.37%)  21
Fracture  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Intraoperative gastrointestinal injury - Appendix  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Thermal burn  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Vascular access complication  1  3/272 (1.10%)  3 1/251 (0.40%)  1
Wound dehiscence  1  0/272 (0.00%)  0 1/251 (0.40%)  2
Investigations     
Activated partial thromboplastin time prolonged  1  4/272 (1.47%)  4 1/251 (0.40%)  1
Alanine aminotransferase increased  1  21/272 (7.72%)  34 22/251 (8.76%)  36
Alkaline phosphatase  1  4/272 (1.47%)  8 5/251 (1.99%)  7
Alkaline phosphatase increased  1  22/272 (8.09%)  32 17/251 (6.77%)  23
Amylase increased  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Aspartate aminotransferase increased  1  36/272 (13.24%)  54 28/251 (11.16%)  36
Blood bilirubin increased  1  16/272 (5.88%)  22 7/251 (2.79%)  8
Coagulopathy  1  5/272 (1.84%)  6 0/251 (0.00%)  0
Creatine phosphokinase increased  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Creatinine increased  1  22/272 (8.09%)  29 17/251 (6.77%)  34
Gamma-glutamyltransferase increased  1  2/272 (0.74%)  4 2/251 (0.80%)  4
Haptoglobin decreased  1  1/272 (0.37%)  1 0/251 (0.00%)  0
INR increased  1  4/272 (1.47%)  5 2/251 (0.80%)  2
Laboratory test abnormal  1  3/272 (1.10%)  5 4/251 (1.59%)  4
Leukocyte count decreased  1  177/272 (65.07%)  409 177/251 (70.52%)  458
Lipase increased  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Lymphocyte count decreased  1  39/272 (14.34%)  75 32/251 (12.75%)  67
Neutrophil count decreased  1  178/272 (65.44%)  333 166/251 (66.14%)  361
Platelet count decreased  1  92/272 (33.82%)  167 74/251 (29.48%)  145
Weight gain  1  0/272 (0.00%)  0 3/251 (1.20%)  3
Weight loss  1  59/272 (21.69%)  96 51/251 (20.32%)  90
Metabolism and nutrition disorders     
Acidosis  1  0/272 (0.00%)  0 1/251 (0.40%)  2
Alkalosis  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Anorexia  1  148/272 (54.41%)  279 140/251 (55.78%)  294
Blood bicarbonate decreased  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Blood glucose increased  1  41/272 (15.07%)  66 47/251 (18.73%)  77
Dehydration  1  33/272 (12.13%)  45 31/251 (12.35%)  45
Serum albumin decreased  1  32/272 (11.76%)  40 28/251 (11.16%)  44
Serum calcium decreased  1  28/272 (10.29%)  38 23/251 (9.16%)  28
Serum glucose decreased  1  5/272 (1.84%)  8 10/251 (3.98%)  13
Serum magnesium decreased  1  5/272 (1.84%)  7 10/251 (3.98%)  17
Serum magnesium increased  1  2/272 (0.74%)  2 3/251 (1.20%)  4
Serum phosphate decreased  1  2/272 (0.74%)  2 1/251 (0.40%)  2
Serum potassium decreased  1  31/272 (11.40%)  44 26/251 (10.36%)  43
Serum potassium increased  1  7/272 (2.57%)  8 4/251 (1.59%)  4
Serum sodium decreased  1  24/272 (8.82%)  32 14/251 (5.58%)  24
Serum sodium increased  1  2/272 (0.74%)  2 1/251 (0.40%)  1
Serum triglycerides increased  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  8/272 (2.94%)  14 6/251 (2.39%)  7
Arthritis  1  1/272 (0.37%)  1 2/251 (0.80%)  5
Back pain  1  7/272 (2.57%)  12 11/251 (4.38%)  14
Bone pain  1  4/272 (1.47%)  5 0/251 (0.00%)  0
Chest wall pain  1  1/272 (0.37%)  1 3/251 (1.20%)  3
Muscle weakness  1  4/272 (1.47%)  5 2/251 (0.80%)  5
Muscle weakness lower limb  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Musculoskeletal disorder  1  1/272 (0.37%)  2 2/251 (0.80%)  3
Myalgia  1  7/272 (2.57%)  8 4/251 (1.59%)  7
Neck pain  1  1/272 (0.37%)  3 0/251 (0.00%)  0
Pain in extremity  1  1/272 (0.37%)  1 5/251 (1.99%)  7
Nervous system disorders     
Ataxia  1  2/272 (0.74%)  2 2/251 (0.80%)  2
Depressed level of consciousness  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Dizziness  1  15/272 (5.51%)  18 22/251 (8.76%)  33
Dysgeusia  1  27/272 (9.93%)  41 20/251 (7.97%)  39
Extrapyramidal disorder  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Headache  1  13/272 (4.78%)  17 17/251 (6.77%)  23
Memory impairment  1  0/272 (0.00%)  0 1/251 (0.40%)  2
Neuralgia  1  0/272 (0.00%)  0 2/251 (0.80%)  4
Neurological disorder NOS  1  2/272 (0.74%)  4 0/251 (0.00%)  0
Neuropathy - cranial  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Peripheral motor neuropathy  1  2/272 (0.74%)  2 5/251 (1.99%)  6
Peripheral sensory neuropathy  1  34/272 (12.50%)  55 38/251 (15.14%)  62
Syncope  1  3/272 (1.10%)  3 4/251 (1.59%)  4
Syncope vasovagal  1  0/272 (0.00%)  0 3/251 (1.20%)  3
Tremor  1  2/272 (0.74%)  3 3/251 (1.20%)  4
Psychiatric disorders     
Anxiety  1  5/272 (1.84%)  7 12/251 (4.78%)  27
Depression  1  9/272 (3.31%)  13 18/251 (7.17%)  29
Euphoria  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Insomnia  1  17/272 (6.25%)  22 16/251 (6.37%)  23
Libido decreased  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Renal and urinary disorders     
Bladder pain  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Hematuria (in the absence of vaginal bleeding)  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Hemoglobin urine positive  1  1/272 (0.37%)  1 1/251 (0.40%)  2
Incontinence  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Proteinuria  1  0/272 (0.00%)  0 2/251 (0.80%)  2
Ureteric obstruction  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Urinary frequency  1  3/272 (1.10%)  3 4/251 (1.59%)  5
Urinary retention  1  0/272 (0.00%)  0 1/251 (0.40%)  3
Urine discoloration  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Urogenital disorder  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Reproductive system and breast disorders     
Irregular menstruation  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Vaginal inflammation  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  4/272 (1.47%)  7 2/251 (0.80%)  3
Aspiration  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Bronchospasm  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Cough  1  25/272 (9.19%)  35 18/251 (7.17%)  25
Dyspnea  1  9/272 (3.31%)  13 7/251 (2.79%)  12
Dyspnea (shortness of breath)  1  6/272 (2.21%)  8 5/251 (1.99%)  7
Epistaxis  1  8/272 (2.94%)  9 7/251 (2.79%)  7
Hiccups  1  1/272 (0.37%)  1 7/251 (2.79%)  7
Hypoxia  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Nasal congestion  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Pharyngolaryngeal pain  1  3/272 (1.10%)  3 4/251 (1.59%)  4
Pleural effusion  1  1/272 (0.37%)  1 5/251 (1.99%)  6
Pleuritic pain  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Pneumonitis  1  2/272 (0.74%)  4 1/251 (0.40%)  1
Respiratory disorder  1  4/272 (1.47%)  4 3/251 (1.20%)  3
Respiratory tract hemorrhage  1  2/272 (0.74%)  3 0/251 (0.00%)  0
Voice alteration  1  3/272 (1.10%)  6 2/251 (0.80%)  2
Skin and subcutaneous tissue disorders     
Alopecia  1  21/272 (7.72%)  37 49/251 (19.52%)  104
Decubitus ulcer  1  1/272 (0.37%)  3 0/251 (0.00%)  0
Dermatology  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Dry skin  1  9/272 (3.31%)  12 6/251 (2.39%)  8
Erythema multiforme  1  1/272 (0.37%)  3 1/251 (0.40%)  1
Hand-and-foot syndrome  1  36/272 (13.24%)  52 46/251 (18.33%)  75
Nail disorder  1  4/272 (1.47%)  4 14/251 (5.58%)  21
Photosensitivity  1  0/272 (0.00%)  0 1/251 (0.40%)  1
Pigmentation changes (e.g., vitiligo)  1  0/272 (0.00%)  0 2/251 (0.80%)  6
Pruritus  1  6/272 (2.21%)  11 4/251 (1.59%)  7
Rash acneiform  1  1/272 (0.37%)  2 1/251 (0.40%)  1
Rash desquamating  1  30/272 (11.03%)  39 13/251 (5.18%)  16
Rash/dermatitis associated with high-dose chemotherapy or BMT studies.  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Skin disorder  1  7/272 (2.57%)  10 3/251 (1.20%)  3
Skin hyperpigmentation  1  5/272 (1.84%)  8 7/251 (2.79%)  9
Sweating  1  2/272 (0.74%)  2 6/251 (2.39%)  7
Vascular disorders     
Flushing  1  4/272 (1.47%)  7 2/251 (0.80%)  3
Hemorrhage  1  2/272 (0.74%)  2 0/251 (0.00%)  0
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia  1  1/272 (0.37%)  1 1/251 (0.40%)  1
Hot flashes  1  1/272 (0.37%)  1 2/251 (0.80%)  2
Hypertension  1  0/272 (0.00%)  0 4/251 (1.59%)  5
Hypotension  1  7/272 (2.57%)  10 11/251 (4.38%)  14
Phlebitis  1  1/272 (0.37%)  1 0/251 (0.00%)  0
Thrombosis  1  6/272 (2.21%)  7 10/251 (3.98%)  10
1
Term from vocabulary, MedDRA 6
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charles S. Fuchs, MD, MPH
Organization: Yale Cancer Center
Phone: (203) 785-4095
EMail: charles.fuchs@yale.edu
Publications of Results:
Fuchs C, Tepper JE, Niedwiecki D, et al.: Postoperative adjuvant chemoradiation for gastric or gastroesophageal adenocarcinoma using epirubicin, cisplatin, and infusional (CI) 5-FU (ECF) before and after CI 5-FU and radiotherapy (RT): interim toxicity results from Intergroup trial CALGB 80101. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-61, 2006.
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00052910    
Other Study ID Numbers: CALGB-80101
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000258787 ( Registry Identifier: NCI Physician Data Query )
First Submitted: January 24, 2003
First Posted: January 27, 2003
Results First Submitted: January 23, 2017
Results First Posted: July 17, 2018
Last Update Posted: May 7, 2020