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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000712606

Enrollment

908

Registered

2005-11-04

Start date

2008-10-20

Completion date

2008-10-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Imatinib mesylate (400mg/day) for two years

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

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

Outcome results