A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer
PulMiCC
2 other identifiers
interventional
93
4 countries
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Dec 2010
Longer than P75 for not_applicable colorectal-cancer
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2010
CompletedFirst Posted
Study publicly available on registry
April 19, 2010
CompletedStudy Start
First participant enrolled
December 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2020
CompletedMay 11, 2023
May 1, 2023
6 years
April 13, 2010
May 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility of recruitment
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.
2 years
Secondary Outcomes (1)
Survival
5 years
Study Arms (2)
Pulmonary metastasectomy
EXPERIMENTALPulmonary metastasectomy
Active monitoring
ACTIVE COMPARATORActive monitoring
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- Royal Brompton & Harefield NHS Foundation Trustcollaborator
- University of Cambridgecollaborator
- University of Sussexcollaborator
Study Sites (24)
Henan Cancer Hospital/The affiliated Cancer Hospital
Zhengzhou, 450000, China
Policlinico Hospital
Catania, 95124, Italy
Institute for Lung diseases of Vojvodina
Kamenitz, 21204, Serbia
Basildon University Hospital
Basildon, SS16 5NL, United Kingdom
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Bristol Royal Infirmary
Bristol, BS2 8HW, United Kingdom
Queen's Hospital
Burton-on-Trent, DE13 0RB, United Kingdom
Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
Golden Jubilee National Hospital
Glasgow, G81 4DY, United Kingdom
Glenfield Hospital
Leicester, LE3 9QP, United Kingdom
Liverpool Heart & Chest Hospital
Liverpool, L14 3PE, United Kingdom
The Whittington Hospital
London, N19 5NF, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Guy's and St Thomas' NHS Trust
London, SE1 7EH, United Kingdom
St George's Hospital
London, SW17 0QT, United Kingdom
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Papworth Hospital NHS Trust
Papworth Everard, CB23 3RE, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Sheffield Teaching Hospitals
Sheffield, S5 7AU, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (3)
Milosevic M, Edwards J, Tsang D, Dunning J, Shackcloth M, Batchelor T, Coonar A, Hasan J, Davidson B, Marchbank A, Grumett S, Williams NR, Macbeth F, Farewell V, Treasure T. Pulmonary Metastasectomy in Colorectal Cancer: updated analysis of 93 randomized patients - control survival is much better than previously assumed. Colorectal Dis. 2020 Oct;22(10):1314-1324. doi: 10.1111/codi.15113. Epub 2020 Jun 14.
PMID: 32388895RESULTTreasure T, Farewell V, Macbeth F, Batchelor T, Milosevic M, King J, Zheng Y, Leonard P, Williams NR, Brew-Graves C, Morris E, Fallowfield L; PulMiCC investigators. 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. Colorectal Dis. 2021 Nov;23(11):2911-2922. doi: 10.1111/codi.15833. Epub 2021 Aug 2.
PMID: 34310835DERIVEDTreasure T, Farewell V, Macbeth F, Monson K, Williams NR, Brew-Graves C, Lees B, Grigg O, Fallowfield L; PulMiCC Trial Group. Pulmonary Metastasectomy versus Continued Active Monitoring in Colorectal Cancer (PulMiCC): a multicentre randomised clinical trial. Trials. 2019 Dec 12;20(1):718. doi: 10.1186/s13063-019-3837-y.
PMID: 31831062DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tom Treasure, MD, MS, FRCS
UCL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2010
First Posted
April 19, 2010
Study Start
December 2, 2010
Primary Completion
November 24, 2016
Study Completion
February 29, 2020
Last Updated
May 11, 2023
Record last verified: 2023-05