Trial Information
A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer
Inclusion Criteria:
- Patients with primary colorectal cancer who have undergone resection of the primary
cancer with intent to cure, local control has been confirmed and no clinical
indications of other active colorectal cancer other than the known lung metastases.
Exclusion Criteria:
- Previous malignancy likely to interfere with protocol treatment or measurement of
endpoints, any concurrent illness which could interfere with the treatment protocol
or confound survival, unavailable for follow up and assessment according to protocol,
psychiatric or mental incapacity that precludes fully informed consent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility of recruitment
Outcome Description:
We wish to measure the monthly recruitment rate from approximately 11-12 centres over 2 years. This feasibility study aims to determine whether it will be possible to recruit sufficient patients to conduct a larger randomised trial which would be powered to measure survival as the primary outcome.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Tom Treasure, MD, MS, FRCS
Investigator Role:
Principal Investigator
Investigator Affiliation:
UCL
Authority:
United Kingdom: Research Ethics Committee
Study ID:
Reference No: 08/0390
NCT ID:
NCT01106261
Start Date:
April 2010
Completion Date:
October 2012
Related Keywords:
- Colorectal Cancer
- Pulmonary Metastases
- Colorectal Neoplasms
- Neoplasm Metastasis
- Lung Neoplasms