ISRCTN - ISRCTN63599281: Surgery versus no surgery of residual disease in patients with metastatic gastro-intestinal stromal tumour

Plain English Summary

http://www.cancerhelp.org.uk/trials/a-trial-surgery-imatinib-gastrointestinal-stromal-tumours

Trial website

Contact information

Type

Scientific

Primary contact

Ms Holly White

ORCID ID

Contact details

550 Wilmslow Road
Manchester
M20 4BX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

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 below 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

Other

Phase

Phase III

Drug names

Primary outcome measures

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

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