A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC)
Recruitment status was Not yet recruiting
Patients who have been treated successfully for bowel cancer (colorectal cancer) sometimes go on to develop nodules of disease in another part of the body. If this disease is found to be related to the original cancer it is called a metastasis. Some patients develop one or more metastases particularly in the lungs or the liver.
There is a growing trend to remove lung metastases with an operation, in the belief that this will help patients live longer, however there have not been any scientific studies to prove this. There is also very little published information about the side effects of this surgery and how it affects subsequent daily living. This is a feasibility study to determine whether it will be possible to conduct a large randomised controlled trial investigating the value of pulmonary metastasectomy (surgery to remove lung metastases) in patients who have been successfully treated for colorectal cancer. There is a two stage consent and randomisation process. Firstly, patients will be invited to consent to having a full range of investigations to assess their suitability for surgery. If found to be suitable, they will then be invited to consent to randomisation between active monitoring of their disease or active monitoring with pulmonary metastasectomy. Patients will be followed up regularly for 5 years to assess their disease status and to measure their quality of life and lung function.
Procedure: Active monitoring
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer|
- Feasibility of recruitment [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- Survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Overall survival, Relapse free survival, Lung function (measured by FEV1), Patient reported quality of life (STAI, FACT-An-L and EQ-5D questionnaires), Health economic assessment
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: Pulmonary metastasectomy
Active Comparator: Active monitoring
Procedure: Active monitoring
|Contact: Tom Treasure, MD MS FRCS||07957 email@example.com|
|Clinical Trials and Evaluation Unit||Not yet recruiting|
|London, United Kingdom, SW3 6NP|
|Contact: Belinda Lees, PhD 0207 351 8827 firstname.lastname@example.org|
|Principal Investigator:||Tom Treasure, MD, MS, FRCS||UCL|