Plain English Summary
http://www.cancerhelp.org.uk/trials/a-trial-surgery-imatinib-gastrointestinal-stromal-tumours
Trial website
Additional identifiers
EudraCT number
2007-002257-23
ClinicalTrials.gov number
NCT00956072
Protocol/serial number
7150
Study information
Scientific title
A phase III randomised study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to Imatinib mesylate
Acronym
EORTC 62063
Study hypothesis
The two principle objectives for this study are as follows:
1. To evaluate if surgery of residual disease in patients with advanced gastro-intestinal stromal tumour (GIST) responding to imatinib improves the progression free survival
2. To correlate the pharmacokinetics of imatinib and its metabolites in both arms with the pharmacokinetics of imatinib and its metabolites before randomisation
Ethics approval
Central Manchester REC on 04/082009 (ref: 09/H1008/90)
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Sarcoma; Disease: Soft Tissue
Intervention
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.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
Progression free survival (PFS), measured from the date of randomisation for surgery
Secondary outcome measures
Overall survival (OS) from the time of randomisation to death
Overall trial start date
28/10/2009
Overall trial end date
01/05/2015
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 350
Participant exclusion criteria
No prior treatment with imatinib or other tyrosine kinase inhibitors (for any reason) in the adjuvant or neoadjuvant setting
Recruitment start date
28/10/2009
Recruitment end date
01/05/2015
Locations
Countries of recruitment
Australia, France, Germany, Italy, Netherlands, New Zealand, Spain, United Kingdom
Trial participating centre
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
Sponsor information
Organisation
European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Sponsor details
Avenue Mounierlaan
83/11
Brussels
1200
Belgium
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
European Organisation for Research and Treatment of Cancer
Alternative name(s)
EORTC
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Belgium
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list