A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer | Not Recruiting
A Randomised Trial of Pulmonary Met... | Not Recruiting
A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer
PulMiCC

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Medical Conditions
  • Colorectal Cancer
  • Pulmonary Metastases
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT01106261
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
  • Colorectal cancer is one of the three commonest solid tumours. Approximately 100 cases are diagnosed each day in the UK. In 2006, 37,514 cases of colorectal cancer were diagnosed.

    The increasing use of CT scans in routine follow up of patients has led to earlier diagnosis of isolated and/or subclinical lung nodules and there has been widespread adoption of pulmonary metastasectomy in selected cases. A survey of practice in Europe showed that pulmonary metastasectomy is very commonly performed but criteria vary widely. About 300 such operations were being carried out annually in the UK when PulMiCC opened as a 'feasibility' study.

    Although well-established in clinical practice there have been no previous randomised controlled trials of the effect of lung metastasectomy on survival and there is doubt as to its clinical effectiveness. The most recent systematic review and meta-analysis concludes that pulmonary metastasectomy is associated with a high likelihood of recurrence, with doubling of the recurrence rate with each of three adverse prognostic factors: (i) more than one metastasis, (ii) an interoperative interval (primary resection to lung metastasectomy) less than three years, (iii) elevated CEA.

    In a prospective registry capturing more than 60% of Spanish practice for a two year period these limits were commonly exceeded.

    In an RCT it has been shown that recurrence can be detected earlier with CT and/or CEA surveillance and as a result more liver and lung metastasectomy operations were performed. However, these operations did not provide any survival benefit, within the RCT. The uncertainty about the practice has been set out in the British Medical Journal in 2014.

    Pulmonary metastasectomy is thus part of a bigger question about effectiveness of surgery for metastases from colorectal cancer.

    There are known unfavourable prognostic factors which include the number of metastases and the length of time they take to become evident radiologically: (a) a solitary nodule appearing after a long interval is will be removed in most instances, (b) surgery is rarely advocated when there are multiple metastases present at the time of surgery on the primary colorectal cancer or appearing soon after.

    These scenarios represent opposite ends of the continuum of favourable to adverse factors for survival after resection of pulmonary metastases. Most patients operated on fall between these extremes and it is evident that if there is a "yes" towards one end of the continuum and "no" towards the other that there must be cross over zone where there is clinical uncertainty. PulMiCC aims to investigate the outcome following pulmonary metastasectomy in patients where there is accepted clinical uncertainty, to provide evidence to guide practice in the future.

    It has also been shown previously that trials requiring patients to consider randomisation between treatments that appear very different, as in this instance between surgery or no surgery, can experience recruitment difficulties. This is because potential participants may have acquired a strong preference for one of the treatments over the other and they are not willing to accept the possibility of being allocated to the less non-preferred option alternative.

    There can also be problems of bias if one treatment is mentioned to the patient before the option of a trial is introduced; the first mentioned treatment may be perceived to be preferred between doctor and patient. This trial has been designed to overcome these potential difficulties and maximise recruitment as follows.

    Colorectal cancer patients presenting with pulmonary metastases will first be consented for registration into the study. This consent is to undergo evaluation according to the trial protocol as part of the work up for consideration by the MDT. Following evaluation, the MDT will consider how they would normally treat each patient according to their standard local practice. Patients eligible for randomisation will be those for whom clinical uncertainty exists as to whether surgery would be of benefit. This trial design was successful in a study of the feasibility of randomising patients in a trial of mesothelioma surgery.

    The time taken for patients to undergo the full range of tests for evaluation gives them time to think carefully about the possible treatment options and discuss them with their doctor. In addition to the patient information leaflet, patients will be invited to take home a DVD explaining the trial in detail, which can be watched as often as the patient likes. It is hoped that those who are ultimately identified as eligible for randomisation will have fewer anxieties because of their extended opportunity to consider the trial.

    Local site research staff involved in recruiting patients will attend a training session to learn the best method of informing patients about the trial before recruitment commences.
Phase
N/A
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Procedure : Metastasectomy, Procedure : Active monitoring

Study Arm Groups : Pulmonary metastasectomy, Active monitoring

Intervention Type
See Interventions above
Primary Outcome Measures
    Feasibility of recruitment; 2 years
Secondary Outcome Measures
    Survival; 5 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
16 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
Bordesley Green
B9 5SS
GSK Investigational Site
London
NW3 2QG
Manchester
M20 4BX
London
SE1 7EH
St. George's Hospital
London
England
SW17 0QT
Velindre Cancer Center at Velindre Hospital
Cardiff
Wales
CF14 2TL
Plymouth
PL6 8DH
Musculoskeletal Department; Freeman Hospital
Newcastle upon Tyne
NE7 7DN
Royal Brompton Hospital
London
SW3 6NP
Nottingham
Nottinghamshire
NG5 1PB
Novartis Investigative Site
Wolverhampton
WV10 0QP
Basildon University Hospital
Basildon
England
SS16 5NL
Sheffield Kidney Institute
Sheffield
S5 7AU
Cardiothoracic Centre - Liverpool
Liverpool
L14 3PE
Bristol
BS2 8HW
Middlesbrough
TS4 3BW
Study Site - 24010
Leicester
Leicestershire
LE3 9QP
Papworth Hospital NHS Foundation Trust
Papworth Everard
CB23 3RE
Whittington Hospital
London
England
N19 5NF
Queens Hospital
Burton-on-Trent
DE13 0RB
Clydebank
West Dunbartonshire
G81 4DY
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
China, Italy, Serbia, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer
EudraCT Number
Not available for this trial
Funder(s)
  • Royal Brompton & Harefield NHS Foundation Trust
  • University of Cambridge
  • University of Sussex
Other Study ID Numbers
Reference No: 08/0390
Sponsor(s)
University College, London
Key Dates

Recruitment Start Date

Apr 2010

Recruitment End Date

Jun 2020

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

13 Apr 2010

Date updated in source

23 May 2017