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

550 Wilmslow Road
Manchester
M20 4BX
United Kingdom

Study information

Study designRandomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA phase III randomised study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to Imatinib mesylate
Study acronymEORTC 62063
Study objectivesThe 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) studiedTopic: National Cancer Research Network; Subtopic: Sarcoma; Disease: Soft Tissue
InterventionEligible 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 typeMixed
Primary outcome measureProgression free survival (PFS), measured from the date of randomisation for surgery
Secondary outcome measuresOverall survival (OS) from the time of randomisation to death
Overall study start date28/10/2009
Completion date01/05/2015
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 350
Key inclusion criteria1. 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 criteriaNo prior treatment with imatinib or other tyrosine kinase inhibitors (for any reason) in the adjuvant or neoadjuvant setting
Date of first enrolment28/10/2009
Date of final enrolment01/05/2015

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

Sponsor information

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Research organisation

Avenue Mounierlaan, 83/11
Brussels
1200
Belgium

Website http://www.eortc.be/
ROR logo "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
Alternative name(s)
EORTC
Location
Belgium

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.