Phase III Randomized Prospective Trial of Open Versus Minimally Invasive, Video-Assisted Resection of Pulmonary Metastases

Trial Information

Phase III Randomized Prospective Trial of Open Versus Minimally Invasive, Video-Assisted Resection of Pulmonary Metastases

OBJECTIVES: I. Compare the overall survival and failure free survival of patients with
isolated pulmonary metastases treated with minimally invasive (video assisted) resection or
open resection. II. Compare patterns of recurrence in these patients after these treatments,
and determine what factors are predictive of recurrence. III. Describe and compare the
complications and morbidity associated with minimally-invasive and open approaches to
metastasectomy in these patients. IV. Test whether the patients undergoing video-assisted
thoracic surgery will have a significantly better quality of life over a six month period
than those undergoing an open resection.

OUTLINE: This is a randomized study. Patients are stratified according to histology (sarcoma
vs epithelial vs germ cell vs melanoma) and disease laterality. After spiral CT showing
pulmonary nodules are amenable to video-assisted thoracic surgery (VATS) resection with
curative intent, patients are randomized to undergo either open resection (thoracotomy,
median sternotomy, or bilateral sternothoracotomy) (arm I) or minimally-invasive
video-assisted resection (arm II). Patients with isolated recurrence in the chest should
have the recurrence(s) resected if feasible. The original resection approach (open versus
VATS) should be the preferred method for the second resection, but is not required. Quality
of life is assessed prior to randomization and then at 30 days, 3 months, and 6 months.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: There will be 530 patients accrued into this study in approximately 3
years.