Protocol Title: Intermediate and high-risk localised, completely resected, gastro-intestinal stromal tumours (GIST) expressing c-kit receptor: A controlled randomised trial on adjuvant imatinib mesylate (Glivec ®) versus no further therapy after completing surgery.
Study Chair: Doctor Dusan Kotasek (Adelaide Cancer Centre, SA)
Associate Oncology Program Manager: Ms Christine Aiken
Trial Coordinator: Ms Christine Aiken
Contact Email: adjGIST@ctc.usyd.edu.au
Detailed information available on: Australian and New Zealand Clinical Trials Registry — EORTC 62024
Grants Awarded: Novartis Pharmaceuticals Australia P/L, Cancer Council of South Australia, Cancer Council of Victoria, Cancer Council of New South Wales, Queensland Cancer Fund and European Organisation for Research and Treatment of Cancer (Belgium)
Aims: While imatinib had been shown to be highly effective in prolonging survival in patients with metastatic GIST, its efficacy in the adjuvant setting was unknown. The overall aim of the adjuvant GIST trial was to assess whether imatinib, as an adjunct to complete surgery, was able to improve the prognosis of patients with intermediate and high-risk, localised GIST. The primary objective of the trial was to compare overall survival between the treatment and observation groups. The secondary objectives were to compare relapse-free survival and relapse free interval between the treatment and observation groups and to assess the safety of imatinib given as an adjuvant to complete surgery. Imatinib mesylate is highly effective in advanced, unresectable GIST. However, the long-term effect of this agent on survival outcomes remains unclear. This study will compare the effect of adjuvant imatinib mesylate versus observation only on the prognosis of patients with completely resected localised gastrointestinal stromal tumours at intermediate- or high-risk of relapse.
Study Design: The adjuvant GIST trial is an open label, randomised phase III trial comparing adjuvant imatinib mesylate (400mg/day) for two years to no further anti-tumour therapy in patients with fully resected GIST at intermediate to high risk of relapse.
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