Surgery versus no surgery of residual disease in patients with metastatic gastro-intestinal stromal tumour
| ISRCTN | ISRCTN63599281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63599281 |
| EudraCT/CTIS number | 2007-002257-23 |
| ClinicalTrials.gov number | NCT00956072 |
| Secondary identifying numbers | 7150 |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 04/08/2017
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
http://www.cancerhelp.org.uk/trials/a-trial-surgery-imatinib-gastrointestinal-stromal-tumours
Contact information
Ms Holly White
Scientific
Scientific
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
Study information
| Study design | Randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A phase III randomised study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to Imatinib mesylate |
| Study acronym | EORTC 62063 |
| Study objectives | 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(s) | Central Manchester REC on 04/082009 (ref: 09/H1008/90) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 28/10/2009 |
| Completion date | 01/05/2015 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 350 |
| Key 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 |
| Key exclusion criteria | No prior treatment with imatinib or other tyrosine kinase inhibitors (for any reason) in the adjuvant or neoadjuvant setting |
| Date of first enrolment | 28/10/2009 |
| Date of final enrolment | 01/05/2015 |
Locations
Countries of recruitment
- Australia
- England
- France
- Germany
- Italy
- Netherlands
- New Zealand
- Spain
- United Kingdom
Study participating centre
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
M20 4BX
United Kingdom
Sponsor information
European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Research organisation
Research organisation
Avenue Mounierlaan, 83/11
Brussels
1200
Belgium
| Website | http://www.eortc.be/ |
|---|---|
"ROR" |
https://ror.org/034wxcc35 |
Funders
Funder type
Research organisation
European Organisation for Research and Treatment of Cancer
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- EORTC
- Location
- Belgium
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
04/08/2017: The trial was stopped on 11/03/2011 due to participant recruitment issues.
