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Randomized trial of Open vs VATS for pulmonary metastases

Originating Group

CALGB 39804

P.I.: Dr. Joshua Sonett

Participating Groups

Objectives

  1. To compare the overall survival between a minimally-invasive and open approach to the treatment of isolated pulmonary metastases.
  2. To compare the failure-free survival between a minimally-invasive and open appraoch to the treatment of isolated pulmonary metastases
  3. To compare patterns of recurrence with minimally invasive and open approaches to the treatment of isolated pulmonary metastases, and to determine what factors are predictive of recurrence
  4. To describe and compare the complications and morbidity associated with minimally-invasive and open approaches to metastasectomy.
  5. To test whether patients undergoing VATS will have a significantly better quality of life over a six month period than those undergoing an open resectin for the treatment of isolated pulmonary metastases, in terms of their physical symptoms,physical, vocational and social functioning,psychological state and body image.

Eligibility

  1. Pulmonary metastases identified by spiral CT scan
  2. Documented previous cancer with no history of previous metastasectomy.
  3. The primary tumor must be definitively controlled. No evidence of primary tumor recurrence either locally or systemically with the patient having evidence of pulmonary metastasis only.
  4. No extra-pulmonary metastatic disease or evidence of mediastinal lymph node involvement. Lymph nodes >1.0cm on CT scan must be proven to be benign by tissue biopsy (mediastinoscopy).
  5. The pulmonary metastases must be judged all amenable to minimally-invasive resection by the credentialled thoracic surgeon. There may be multiple lesions (4 or less), unilateral or bilateral, as long as they can all be resected by VATS with curative intent (complete removal of all documented lesions).
  6. <=4 lesions.
  7. Performance status 0-2.
  8. Age > 18 years.

Schema

Comments

activated 2/15/99
closed 9/29/2000 due to poor accrual
accrual 9/530 as of 5/2000



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