Surgery versus no surgery of residual disease in patients with metastatic gastro-intestinal stromal tumour

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Sarcoma; Disease: Soft Tissue; Cancer; Gastro-intestinal stromal tumour

• Registration Number: ISRCTN63599281
• Lead Sponsor: European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-29
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Histologically confirmed GIST expressing CD117+, or with documented mutation of the KIT or PDGFRA gene
2. Metastatic disease (liver and/or abdominal cavity); no extra-abdominal metastases
3. Treatment with imatinib administered for 6 - 12 months, resulting in complete remission (CR), partial remission (PR) or stable disease (SD), without progressive disease (PD) since the start of imatinib therapy (Response Evaluation Criteria in Solid Tumours [RECIST])
4. Measurable disease (RECIST) before start of imatinib
5. Surgically resectable residual disease (assessed on computed tomography [CT] scan/magnetic resonance imaging [MRI])
6. Aged greater than or equal to 18 years (either sex)
7. World Health Organization (WHO) performance status 0 to 1
8. Adequate haematological and organ function

Exclusion Criteria

No prior treatment with imatinib or other tyrosine kinase inhibitors (for any reason) in the adjuvant or neoadjuvant setting

Study & Design

• Study Type: Interventional
• Study Design: Not specified