Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

NCT01267695 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-02-03

No results posted yet for this study

Summary

Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Perioperative imatinib mesylate may shrink the tumor and may reduce the chance of relapse after surgery. This phase II trial is studying the effectiveness of perioperative imatinib mesylate in treating patients with locally advanced gastrointestinal stromal tumor.

Conditions

  • Gastrointestinal Stromal Tumor

Interventions

DRUG

imatinib mesylate

Patients receive oral imatinib mesylate once daily for 6 months in the absence of disease progression or unacceptable toxicity. Patients with disease progression or unacceptable toxicity are considered for immediate surgical resection. Within 2-6 weeks after completion of imatinib mesylate, patients with responding or stable disease undergo surgical resection. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for one and a half years.

PROCEDURE

conventional surgery

All the patients should receive elective surgery with R0 resection.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01267695 on ClinicalTrials.gov