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GIST

ACOSOG Z9001: A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor (GIST)

Unique Dataset IDGIST_Allianc_2002_157
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderThe Alliance for Clinical Trials in OncologyTotal Study Enrolled Patients733Comparator (Control) Arm Enrolled Patients411Experimental (Active) Arm Enrolled Patients362RandomizationYesClinicalTrial.gov IDNCT00041197ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00041197
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataBoth comparator and experimental arm dataIntervention TypePlacebo, ChemotherapyDataset TypeADS

Clinical Trial Title

ACOSOG Z9001: A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor (GIST)

Trial Summary and Conditions

This randomized phase III trial is studying imatinib mesylate to see how well it works compared to placebo in treating patients with primary gastrointestinal stromal tumor that has been completely removed by surgery. Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for patients with primary gastrointestinal stromal tumor that has been completely removed by surgery. Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment Study arms: I. STI571 Arm: Adjuvant treatment with STI571 at 400mg/day for 1 year. II. Placebo Arm: Adjuvant treatment with a matching placebo for 1 year.

Data Summary

Control and experimental arm data files include data on safety, efficacy, demographics, etc. See the data dictionary provided for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To determine whether patients with resected primary gastrointestinal stromal tumor (GIST) who are randomized to the STI571 (imatinib mesylate) Arm have longer recurrence-free survival as compared to the patients randomized to the placebo Arm. SECONDARY OBJECTIVES: I. To ascertain whether patients with resected primary GIST who are randomized to the STI571 Arm have longer survival as compared to the patients randomized to the placebo Arm. II. To obtain from patients with GIST: tumor tissue (before therapy with STI571 and if the patient develops recurrence), blood specimens (before therapy with STI571), and serum specimens (before therapy with STI571, after completing therapy with STI571, and if the patient develops recurrence) for scientific correlative analyses. III. To assess the safety/efficacy of oral STI571 therapy in the adjuvant setting.

Outcome Measures

Primary Outcome Measures: I. Recurrence-free survival (RFS) [ Time Frame: From date of resection to the date of first observation of recurrence, assessed up to 10 years ] [ Designated as safety issue: No ] An O'Brien-Fleming bound will be used to stop the trial early for superiority of the STI571 arm. Secondary Outcome Measures: I. Safety as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ] Safety analysis will consist of routine tabulations, detailed documentation concerning all adverse events, detailed documentation of any unusual events, and any special reports, analyses, or tabulations requested by the DSMC. II. Relationship between genetic and phenotypic characteristics of GIST and clinical outcomes [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Available Downloads:

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

PROTOCOL: Z9001-07.pdf

CRF: z9001_crf.pdf

DATA DICTIONARY: z9001_datadictionary.pdf

DATA (BOTH COMPARATOR AND ACTIVE ARMS): a_adeers.csv

DATA (BOTH COMPARATOR AND ACTIVE ARMS): a_drgexp.csv

DATA (BOTH COMPARATOR AND ACTIVE ARMS): a_effsbj.csv

DATA (BOTH COMPARATOR AND ACTIVE ARMS): a_ident.csv

DATA (BOTH COMPARATOR AND ACTIVE ARMS): a_effsen.csv

DATA (BOTH COMPARATOR AND ACTIVE ARMS): a_lab.csv

DATA (BOTH COMPARATOR AND ACTIVE ARMS): a_aev.csv