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A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer


N/A
16 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Pulmonary Metastases

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Trial Information

A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of recruitment

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Tom Treasure, MD, MS, FRCS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCL

Authority:

United Kingdom: Research Ethics Committee

Study ID:

Reference No: 08/0390

NCT ID:

NCT01106261

Start Date:

April 2010

Completion Date:

October 2012

Related Keywords:

  • Colorectal Cancer
  • Pulmonary Metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Lung Neoplasms

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