SSG XXII
Research type
Research Study
Full title
Three versus five years of adjuvant imatinib as treatment of patients with operable GIST with a high risk of recurrence: A randomised phase III multi-centre study by the Scandanavian Sarcoma Group
IRAS ID
194284
Contact name
Venkata Ramesh Bulusu
Contact email
Sponsor organisation
Scandinavian Sarcoma Group
Eudract number
2014-000898-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
13 years, 2 months, 30 days
Research summary
Three years is considered the standard length of time to receive imatinib therapy after surgery for patients with operable high risk gastro-intestinal stromal tumour (GIST) based on the findings of the SSGXVIII/AIO trial. However, many patients are still at a high risk of GIST coming back even after 3 years of adjuvant imatinib, and may benefit from receiving treatment for longer than 3 years. This trial will look at the effect of efficacy and safety of 5 years of imatinib treatment compared to 3 years.
Study hypothesis: a further 2 years of adjuvant imatinib may improve recurrence-free survival (RFS) of patients who are at a high risk of GIST recurrence despite completion of 3 years of adjuvant imatinib.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0234
Date of REC Opinion
2 Aug 2016
REC opinion
Further Information Favourable Opinion