Clinical Trials/ACTRN12605000712606

ACTRN12605000712606

Completed

Phase 3

Intermediate and high risk localised, completely resected, gastrointestinal stromal tumours (GIST) expressing KIT recepto: a controlled randomised trial on adjuvant Imatinib mesylate (Glivec) versus no further therapy after complete surgery

AGITG0 sites400 target enrollmentNovember 4, 2005

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: AGITG
Enrollment: 400
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 4, 2005

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

AGITG

Eligibility Criteria

Inclusion Criteria

•Histologically proven diagnosis of GIST (positive for CD117\), intermediate or high risk of relapse documented on surgical specimen, surgery performed between 2 weeks and 3 months before treatment start , non evidence of residual macroscopic disease after surgery (R0 or R1 resection only), no prior treatment for GIST (ie. radiotherapy, chemotherapy, molecular targeted therapy, biological therapy), absence of distant metastases, WHO performance status 0\-2\.

Exclusion Criteria

•No exclusion criteria

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Intermediate and high risk localized, completely resected, gastrointestinal stromal tumors (GIST) expressing KIT receptor: a controlled randomized trial on adjuvant Imatinib mesylate (Glivec) versus no further therapy after complete surgery

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