A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC)
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|ClinicalTrials.gov Identifier: NCT01106261|
Recruitment Status : Active, not recruiting
First Posted : April 19, 2010
Last Update Posted : October 2, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Pulmonary Metastases||Procedure: Metastasectomy Procedure: Active monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer|
|Actual Study Start Date :||April 2010|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Pulmonary metastasectomy
Active Comparator: Active monitoring
Procedure: Active monitoring
- Feasibility of recruitment [ Time Frame: 2 years ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106261
|Principal Investigator:||Tom Treasure, MD, MS, FRCS||UCL|