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A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer

NCT01106261 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2023-05-11

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Metastasectomy

Pulmonary Metastasectomy

PROCEDURE

Active monitoring

Active monitoring

Sponsors & Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

    collaborator OTHER

  • University of Cambridge

    collaborator OTHER

  • University of Sussex

    collaborator OTHER

  • University College, London

    lead OTHER

Principal Investigators

  • Tom Treasure, MD, MS, FRCS · UCL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-02
Primary Completion
2016-11-24
Completion
2020-02-29

Countries

  • China
  • Italy
  • Serbia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01106261 on ClinicalTrials.gov