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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Royal Brompton & Harefield NHS Foundation Trust
University of Cambridge
University of Sussex
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01106261
First received: April 13, 2010
Last updated: May 23, 2017
Last verified: May 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 93
Actual Study Start Date: April 2010
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106261

Locations
China
Henan Cancer Hospital/The affiliated Cancer Hospital
Zhengzhou, China, 450000
Italy
Policlinico Hospital
Catania, Italy, 95124
Serbia
Institute for Lung diseases of Vojvodina
Sremska Kamenica, Serbia, 21204
United Kingdom
Basildon University Hospital
Basildon, United Kingdom, SS16 5NL
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
Queen's Hospital
Burton upon Trent, United Kingdom, DE13 0RB
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Golden Jubilee National Hospital
Glasgow, United Kingdom, G81 4DY
Glenfield Hospital
Leicester, United Kingdom, LE3 9QP
Liverpool Heart & Chest Hospital
Liverpool, United Kingdom, L14 3PE
The Whittington Hospital
London, United Kingdom, N19 5NF
Royal Free Hospital
London, United Kingdom, NW3 2QG
Guy's and St Thomas' NHS Trust
London, United Kingdom, SE1 7EH
St George's Hospital
London, United Kingdom, SW17 0QT
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Papworth Hospital NHS Trust
Papworth Everard, United Kingdom, CB23 3RE
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Sheffield Teaching Hospitals
Sheffield, United Kingdom, S5 7AU
New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
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

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01106261     History of Changes
Other Study ID Numbers: Reference No: 08/0390
CRUK/09/022 ( Other Grant/Funding Number: Cancer Research UK )
Study First Received: April 13, 2010
Last Updated: May 23, 2017

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on June 23, 2017