EORTC 62063 Surgery for residual disease in GIST

• Research type

  Research Study

• Full title

  A phase III randomised study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumour responding to Imatinib mesylate.

• IRAS ID

  16662

• Contact name

  Michael Leahy

• Sponsor organisation

  EORTC

• Eudract number

  2007-002257-23

• Research summary

  The primary objective of this study is to evaluate whether surgery of residual disease in patients with advanced GIST responding to imatinib improves progression-free survival. The standard treatment for this group of patients is imatinib without surgical intervention. Progression-free survival will be measured by radiological assessment as specified on the study visits, and is defined as the amount of time between the date of randomisation and the date of disease progression or death. Safety assessments will be performed on a regular basis including haematology, biochemistry, cardiac assessments and adverse event assessment. Patient visits will be held before randomisation. Once randomised, patients randomised to the experimental/surgery arm will be operated within 4 weeks and then re-evaluated 1 month after surgery. Patients randomised to the control/non-surgery arm will be re-evaluated 2 months after randomisation. Patients on both arms will then be followed up for progression, 5 months after randomisation, and then every 3 months until 5 years after the start of imatinib, and every 6 months thereafter.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/90

• Date of REC Opinion

  4 Aug 2009

• REC opinion

  Further Information Favourable Opinion