CompletedPhase 3ACTRN12605000712606

Adjuvant GIST Trial

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

Sponsor

AGITG

Enrollment

400 participants

Start Date

Oct 20, 2008

Study Type

Interventional

Conditions

Gastrointestinal stromal tumours (GIST)

Eligibility

Sex: Both males and females

Inclusion Criteria1

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.

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Interventions

Imatinib mesylate (400mg/day) for two years

Locations(1)

NSW,QLD,SA,TAS,WA,VIC, Australia

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ACTRN12605000712606