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Gastric, and Esophageal

Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma

Unique Dataset IDMultiple_Allianc_2002_213ClinicalTrial.gov IDNCT00052910
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderThe Alliance for Clinical Trials in OncologyTotal Study Enrolled Patients546Comparator (Control) Arm Enrolled Patients280Experimental (Active) Arm Enrolled Patients266RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeRadiation, ChemotherapyDataset TypeADS

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.

Data Summary

Control and experimental arms are included in the data files. See the data dictionary provided for more details.

Study Objectives

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.

Outcome Measures

Primary Outcome Measures: Overall survival [ Time Frame: 3 years ] Secondary Outcome Measures: Disease free survival [ Time Frame: 4 years ]

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: protocol.pdf

CRF: CRFs.pdf

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