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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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4 September 2017 |
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Main ID: |
ISRCTN63599281 |
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Date of registration:
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29/04/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Surgery versus no surgery of residual disease in patients with metastatic gastro-intestinal stromal tumour
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Scientific title:
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A phase III randomised study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to Imatinib mesylate |
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Date of first enrolment:
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28/10/2009 |
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Target sample size:
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350 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN63599281 |
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Study type:
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Interventional |
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Study design:
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Randomised interventional treatment trial (Treatment)
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Phase:
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Countries of recruitment
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Australia
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France
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Germany
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Italy
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Netherlands
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New Zealand
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Spain
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United Kingdom
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Contacts
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Name:
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Holly
White |
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Address:
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550 Wilmslow Road
M20 4BX
Manchester
United Kingdom |
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Email:
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Topic: National Cancer Research Network; Subtopic: Sarcoma; Disease: Soft Tissue
Cancer
Gastro-intestinal stromal tumour
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Intervention(s)
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Eligible patients will be randomised after 6 to 12 months from starting imatinib for metastatic disease, to surgery of residual disease (investigational arm) or not. Patients allocated to the investigational arm will be operated within the 12th month from imatinib onset. Post-operative imatinib treatment will be restored as soon as possible after surgery. Patients allocated to the standard arm will continue imatinib treatment according to standard practice. In both arms, patients will be followed for disease progression and/or discontinuation of imatinib therapy whenever that may be. Thereafter, patients will be followed for survival.
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Primary Outcome(s)
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Progression free survival (PFS), measured from the date of randomisation for surgery
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Secondary Outcome(s)
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Overall survival (OS) from the time of randomisation to death
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Secondary ID(s)
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NCT00956072
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7150
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2007-002257-23
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Source(s) of Monetary Support
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European Organisation for Research and Treatment of Cancer
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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