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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

Gastro-intestinal stromal tumour (GIST)

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

Inclusion Criteria5

  • Histologically confirmed gastro-intestinal stromal tumour (GIST).
  • Metastatic disease (liver and/or abdominal cavity)
  • Treatment with imatinib mesylate for 6 - 12 months either as standard care or within other clinical studies.
  • Progression not experienced on imatinib.
  • Surgically resectable disease.

Exclusion Criteria5

  • Previous treatment with imatinib or other tyrosince kinase inhibitor (TKI) other than treatment with imatinib in the past 6 - 12 months.
  • Extra-abdominal matastases
  • Myocardial infarction, unstable or uncontrolled cardiac disease within 6 months prior to study entry
  • Coumarin-type anticoagulant >2mg/day within 7 days prior to study entry
  • Pregnancy/breastfeeding

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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