Metastasectomy and Chemotherapy for Lung Metastases from Soft Tissue Sarcoma: A Randomized Phase III Study

Pts must have histological evidence of soft tissue sarcoma. Pts must have < or = 5 lung metastases on CT-scan, radical metastasectomy must be feasible and pt. must have no signs of extra pulmonary disease. In pts with primarily metastatic disease, the primary tumor should be treated according to local standards. Pt must have WBC > or = 3 x 10 9/l, PLTS > or = 120 x 10 9/l, Serum creatinine < or = 140 umol/l or creatinine clearance > or = 60 ml/mm and bilirubin < or = 1.25 x NL. If pt has rec'd neoadjuvant chemotherapy for primary tumor, cumulative doxorubicin dose must not exceed 200 mg/m2 and at least 365 days must have elapsed. Pt must be >/= 16 years of age. Pt must have a WHO performance status of > or = 2. Pt must not have other severe medical illness including psychosis and previous history of cardiovascular disease. Pt must not have other distant mets and/or local recurrence. Pt must not have rec'd previous chemo for metastatic disease. Pt must not have second primary cancer except in situ cervical cancer and/or basal cell carcinoma which has been adequately treated.