Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University College, London.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Royal Brompton & Harefield NHS Foundation Trust
University of Cambridge
University of Sussex
Information provided by:
University College, London
ClinicalTrials.gov Identifier:
NCT01106261
First received: April 13, 2010
Last updated: April 16, 2010
Last verified: April 2010
History of Changes
  Purpose

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 Intervention
Colorectal Cancer
Pulmonary Metastases
 Procedure: Metastasectomy
Procedure: Active monitoring

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University College, London:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 80
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)
Arms Assigned Interventions
Experimental: Pulmonary metastasectomy
Pulmonary metastasectomy
 Procedure: Metastasectomy
Pulmonary Metastasectomy
Active Comparator: Active monitoring
Active monitoring
 Procedure: Active monitoring
Active monitoring

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106261

Contacts
Contact: Tom Treasure, MD MS FRCS 07957 168754 tom.treasure@googlemail.com

Locations
United Kingdom
Clinical Trials and Evaluation Unit Not yet recruiting
London, United Kingdom, SW3 6NP
Contact: Belinda Lees, PhD     0207 351 8827     b.lees@rbht.nhs.uk    
Sponsors and Collaborators
University College, London
Royal Brompton & Harefield NHS Foundation Trust
University of Cambridge
University of Sussex
Investigators
Principal Investigator: Tom Treasure, MD, MS, FRCS UCL
  More Information

No publications provided

Responsible Party: Research Governance Manager, University College London
ClinicalTrials.gov Identifier: NCT01106261     History of Changes
Other Study ID Numbers: Reference No: 08/0390, CRUK/09/022
Study First Received: April 13, 2010
Last Updated: April 16, 2010
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Lung Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013