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Type(s) of Cancer
Esophageal
Study Phase
Phase 3
Study Completion Date
June 2012
NCT00052910Uploaded 10-13-2017
Available for Download
PDS UID: Multiple_Allianc_2002_213
Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma
Provider Information
Provider Data DescriptionOBJECTIVES: 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.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset546
# of Patients Control280
# of Patients Experimental266
DOIhttps://doi.org/10.34949/05b2-5q20
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryRATIONALE: 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 with radiation therapy after surgery may kill any remaining tumor cells following surgery. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating stomach or esophageal cancer. PURPOSE: Randomized phase III trial to compare two different chemotherapy and radiation therapy regimens in treating patients who have undergone surgery for stomach or esophageal cancer.
ConditionsEsophageal Cancer
Gastric Cancer
Intervention TypeDrug: cisplatin
Drug: epirubicin hydrochloride
Drug: fluorouracil
Drug: leucovorin calcium
Radiation: radiation therapy
Drug(s)Drug: fluorouracil
Drug: leucovorin calcium
Drug: cisplatin
Drug: epirubicin hydrochloride
Total Enrolled546
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - Active Comparator
Arm II - Experimental
Secondary IDU10CA031946
PubMed (PMID)34149004
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLprotocol.pdf
CRFCRFs.pdf
DATA DICTIONARYNCT00052910_COMBINED_Data_Dictionary.pdf
DATA (BOTH COMPARATOR AND ACTIVE ARMS)NCT00052910_D1_(EFFICACY).csv
DATA (BOTH COMPARATOR AND ACTIVE ARMS)NCT00052910_D2_(AE).csv
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