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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

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Esophageal, and Stomach

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

Unique Dataset IDnci-data-401ClinicalTrial.gov IDNCT00052910
DownloadableNo
SponsorAlliance for Clinical Trials in OncologyData ProviderNational Cancer InstituteTotal Study Enrolled Patients546RandomizationYesPubMed (PMID)28976791.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeRadiation, DrugDataset TypeOther

Clinical Trial Title

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

Trial Summary and Conditions

RATIONALE: 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.

Data Summary

Refer to Data Dictionary.

Study 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. Correlate the expression of putative prognostic markers (including TS, ERCC-1, MSI, E-cadherin, EGFR, p27, COX-2, and c-erbB-2) with overall survival of patients treated with these regimens. Correlate specific germline polymorphisms related to chemotherapy metabolism and resistance (including UGT2B7 [epirubicin], GST [cisplatin], ERCCI [cisplatin], XRCC1 [cisplatin], TS [5-FU], DPD [5-FU], and EGFR polymorphisms) with treatment-related toxicity and overall survival of these patients. Correlate serum levels of insulin-like growth factor-1 (IGF-1), IGF-2, and IGF-binding protein 3 with overall survival of patients treated with these regimens.

Outcome Measures

Overall Survival , Disease Free Survival

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

NCT00052910-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.

Available Downloads: NCT00052910-D2

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

Data Dictionary: NCT00052910-D2-Data-Dictionary_3.pdf

DATA: NCT00052910-D2-Dataset_1.csv

OTHER: README.pdf

Available Downloads: NCT00052910-D1

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

Data Dictionary: NCT00052910-D1-Data-Dictionary_2.pdf

DATA: NCT00052910-D1-Dataset_2.csv

OTHER: README.pdf