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A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01106261
Recruitment Status : Active, not recruiting
First Posted : April 19, 2010
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
Royal Brompton & Harefield NHS Foundation Trust
University of Cambridge
University of Sussex
Information provided by (Responsible Party):
University College, London

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Pulmonary Metastases Procedure: Metastasectomy Procedure: Active monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pulmonary metastasectomy
Pulmonary metastasectomy
Procedure: Metastasectomy
Pulmonary Metastasectomy

Active Comparator: Active monitoring
Active monitoring
Procedure: Active monitoring
Active monitoring




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Show Show 24 study locations
Sponsors and Collaborators
University College, London
Royal Brompton & Harefield NHS Foundation Trust
University of Cambridge
University of Sussex
Investigators
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Principal Investigator: Tom Treasure, MD, MS, FRCS UCL
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01106261    
Other Study ID Numbers: Reference No: 08/0390
CRUK/09/022 ( Other Grant/Funding Number: Cancer Research UK )
First Posted: April 19, 2010    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases