Not Yet RecruitingPhase 3ACTRN12609000681257

A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to imatinib mesylate


Sponsor

European Organisation for Research and Treatment of Cancer (EORTC)

Enrollment

350 participants

Start Date

Jan 10, 2010

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study evaluates whether surgery to remove remaining tumor tissue helps patients with a type of stomach/intestinal cancer called GIST that has spread, after the cancer has been controlled with the drug imatinib for 6 to 12 months. Participants must be 18 or older.

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.

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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

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)

Christchurch, New Zealand

Auckland, New Zealand

Not known, Belgium

Not known, France

Not known, Italy

Belgium

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ACTRN12609000681257