Principal Investigator - Prof Dame Lesley Fallowfield
Data Manager - Shirley May
Funder: Cancer Research UK
The increasing use of CT scans in routine follow up of colorectal cancer patients has led to earlier diagnosis of cancer deposits in the lungs (pulmonary metastases). These deposits can be removed by surgery (pulmonary metastasectomy) but this procedure carries risks as well as potential benefits. According to the location of the lung deposits, it may be necessary to remove a significant amount of normal lung tissue during the operation. Following surgery, some patients may be left with reduced lung function, which could affect their ability to conduct normal daily activities and negatively affect their quality of life (QoL).
A recent survey showed that surgeos' opinions vary widely in the types of patients they consider for pulmonary metastasectomy due to a lack of evidence regarding which types of patients benefit from it. The PulMiCC trial aimed to investigate the risks and benefits of pulmonary metastasectomy to provide reliable evidence to guide surgeons in the future.
PulMiCC was a two stage randomised controlled trial.
Stage - registrationEligible patients gave consent for tests and evaluation according to the protocol and local practice guidelines. Following evaluation by the local multi-disciplinary team, patients for whom uncertainty existed whether surgery would be of benefit were eligible for stage 2.
Stage 2 randomisationEligible patients were randomised equally between:
- Arm 1, active monitoring according to local practice guidelines (control)
- Arm 2, active monitoring according to local practice guidelines with pulmonary metastasectomy
Quality of life data were collected directly from patients using three questionnaires (FACT An - L, EQ-5D-3L, 6 item short form STAI). It is hoped that analysis of the QoL and clinical data collected in the trial will provide robust evidence on the risks and benefits of pulmonary metastasectomy to guide surgeons and patients in the future.
Current Stage:
Archived
Publication
Pulmonary metastasectomy in colorectal cancer: Time for a trial https://doi.org/10.1016/j.ejso.2008.12.005Publication
Pulmonary Metastasectomy in Colorectal Cancer: The PulMiCC Trial https://doi.org/10.1097/JTO.0b013e3181dca239Publication
Current concepts: pulmonary metastasectomy for colorectal cancerPublication
Pulmonary metastasectomy in colorectal cancer: the PulMiCC trial http://dx.doi.org/10.1136/thoraxjnl-2011-200015Publication
Randomized Controlled Trial of Pulmonary Metastasectomy in Colorectal Cancer: PulMiCC International Is Open in Italy https://doi.org/10.1634/theoncologist.2012-0476Publication
Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC): a phase III, multi-centre clinical trial https://doi.org/10.1186/s13063-019-3837-yPublication
Rapid Response: Re: Colorectal cancer: summary of NICE guidance https://www.bmj.com/content/368/bmj.m461/rr-2Publication
The myth of pulmonary metastasectomy https://www.nature.com/articles/s41416-020-0927-2Publication
Reply to 'Comment on "The myth of pulmonary metastasectomy"' https://www.nature.com/articles/s41416-020-01062-6.Publication
Pulmonary Metastasectomy in Colorectal Cancer: Health Utility scores by EQ-3D-3L in a randomised controlled trial show no benefit from lung metastasectomy https://onlinelibrary.wiley.com/doi/epdf/10.1111/codi.15833Publication
The fallacy of large survival gains from lung metastasectomy in colorectal cancer https://doi.org/10.1016/S0140-6736(20)32760-4Publication
The Pulmonary Metastasectomy in Colorectal Cancer cohort study: Analysis of case selection, risk factors and survival in a prospective observational study of 512 patients https://doi.org/10.1111/codi.15651Publication
The Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC) burden of care study: Analysis of local treatments for lung metastases and systemic chemotherapy in 220 patients in the PulMiCC cohort https://doi.org/10.1111/codi.15833Publication
The Prospective Observational Cohort and the Nested Randomized Controlled Trial in the Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC Study) Question the Reliance on Existing Evidence for the Magnitude of Benefit From Lung Metastasectomy https://doi.org/10.1097/COC.0000000000000847Publication
Removal or ablation of asymptomatic lung metastases should be reconsidered https://doi.org/10.1136/bmj-2022-073042Publication
A prospective multicentre cohort study of colorectal lung metastasectomy with a nested randomized controlled trial: the key points from the pulmonary metastasectomy in colorectal cancer study https://doi.org/10.1093/ejcts/ezae216Poster
Patients' views on the PulMiCC trial information: Results from a survey posters/Accept decline CTM conference May 2017 final.pdf