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Gastric, and Esophageal
Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal AdenocarcinomaUnique Dataset IDMultiple_Allianc_2002_213ClinicalTrial.gov IDNCT00052910
Clinical Trial Title
Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma
Trial Summary and Conditions
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to depth of tumor penetration (T1 or T2 vs T3 vs T4), lymph node involvement (0 vs 1-3), and extent of lymphadenectomy (D1 or D2 vs D0 or unknown). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive leucovorin calcium IV and fluorouracil (5-FU) IV 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 weeks. Patients rest for 28-35 days between course 2 and 3. Arm II: Patients receive epirubicin IV over 3-15 minutes and cisplatin IV over 1 hour on day 1 and 5-FU IV continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and receive 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. Patients are followed every 3 months for 2 years, every 4 months for 2 years, and then annually for 3 years.
Control and experimental arms are included in the data files. See the data dictionary provided for more details.
OBJECTIVES: Compare overall survival in patients with resected gastric adenocarcinoma treated with epirubicin, cisplatin, and infusional fluorouracil (5-FU) vs 5-FU bolus and leucovorin calcium before and after 5-FU plus radiotherapy. Compare disease-free survival and local and distant recurrence rates in these patients treated with these regimens.
Primary Outcome Measures: Overall survival [ Time Frame: 3 years ] Secondary Outcome Measures: Disease free survival [ Time Frame: 4 years ]
To gain access to the data and analytic tools click here.
DATA DICTIONARY: NCT00052910_COMBINED_Data_Dictionary.pdf
DATA (BOTH COMPARATOR AND ACTIVE ARMS): NCT00052910_D1_(EFFICACY).csv
DATA (BOTH COMPARATOR AND ACTIVE ARMS): NCT00052910_D2_(AE).csv