A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to imatinib mesylate
European Organisation for Research and Treatment of Cancer (EORTC)
350 participants
Jan 10, 2010
Interventional
Conditions
Summary
This study evaluates the effectiveness of surgery in treating residual disease in patients with metastatic gastrointestinal stromal cell tumours who are responding to treatment with imatinib mesylate. Patients will be randomly divided into two groups. One group will receive surgery to remove residual disease and continue imatinib therapy. The other group will receive continued imatinib therapy only. Participants will be monitored twice in first 6 months, then every 3 months for the first 5 years, and then every 6 months until any progression of disease. Who is it for? -Patients with metastatic GIST. -Patients who have taken 6-12 months of imatinib mesylate. -Patients with either stable disease or tumour regression since the start of imatinib mesylate.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Surgery to remove residual disease and continued treatment with imatinib mesylate. Patients allocated to the intervention arm will have surgery within 4 weeks of randomisation. The preferred surgery will be a midline laparotomy, but all abdominal incisions will be allowed. All patients will be taking imatinib according to standard clinical practice for the duration of the trial.
Locations(6)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12609000681257