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Type(s) of Cancer
Esophageal, Stomach
Study Phase
Phase 3
Study Completion Date
June 2012
NCT00052910Uploaded 02-12-2020
Access via NCI by Request
PDS UID: nci-data-401
Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma
Provider Information
Provider Data DescriptionNCT00052910-D2-Dataset.csv (efficacy) is one of 2 datasets associated with PubMed ID 28976791. This dataset contains information that will allow you to reproduce the baseline characteristics table and primary analysis.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset546
# of Patients Control0
# of Patients ExperimentalNA
DOIN/A
CDISC StandardNCI standard
Study ArmsUndefined
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)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Age RangeMinimum Age: 18 Years
Maximum Age: NA
Files: NCT00052910-D2
Data DictionaryNCT00052910-D2-Data-Dictionary_3.pdf
DATANCT00052910-D2-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00052910-D1
Data DictionaryNCT00052910-D1-Data-Dictionary_2.pdf
DATANCT00052910-D1-Dataset_2.csv
OTHERREADME.pdf
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