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Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

NCT ID: NCT00171977

Last Updated: 2012-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Brief Summary

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This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative resection of newly diagnosed GIST.Patients will be evaluated for relapse -free survival as measured by the confirmation of tumor recurrence and survival for 3 years after surgery for their primary tumors.

Detailed Description

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Conditions

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Gastrointestinal Stromal Tumors

Keywords

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GIST Imatinib Postoperative Adjuvant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imatinib Mesylate

400 mg once per day

Group Type EXPERIMENTAL

Imatinib Mesylate

Intervention Type DRUG

Interventions

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Imatinib Mesylate

Intervention Type DRUG

Other Intervention Names

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Gleevec/Glivec STI571

Eligibility Criteria

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Inclusion Criteria

* underwent macroscopically curative resection;
* immunohistochemically confirmed KIT (CD117)-positive tumors;
* judged as being high-risk according to the criteria for risk classification

Exclusion Criteria

* synchronous double cancer or metachronous double cancer with a disease-free period of ≤5 years;
* received therapy with Imatinib Mesylate prior to study entry;
* cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria)
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Kanda T, Nishida T, Wada N, Kobayashi O, Yamamoto M, Sawaki A, Boku N, Koseki M, Doi T, Toh Y, Kakeji Y, Sugiyama T, Komatsu Y, Kikuchi S, Ogoshi K, Katai H, Miyachi K, Hirota S, Ohtsu A. Adjuvant therapy with imatinib mesylate after resection of primary high-risk gastrointestinal stromal tumors in Japanese patients. Int J Clin Oncol. 2013 Feb;18(1):38-45. doi: 10.1007/s10147-011-0339-7. Epub 2011 Nov 23.

Reference Type DERIVED
PMID: 22105894 (View on PubMed)

Essat M, Cooper K. Imatinib as adjuvant therapy for gastrointestinal stromal tumors: a systematic review. Int J Cancer. 2011 May 1;128(9):2202-14. doi: 10.1002/ijc.25827.

Reference Type DERIVED
PMID: 21387287 (View on PubMed)

Other Identifiers

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CSTI571BJP07

Identifier Type: -

Identifier Source: org_study_id