Trofosfamide Versus Adriamycin in Elderly Patients With Soft Tissue Sarcoma (STS)

Inclusion Criteria: Histologically established metastatic (N+ or M1 = stage IV) or non-resectable soft tissue sarcoma· Grading II/III (Guillou et al. J Clin Oncol 1997) At least 1 measurable tumor parameter according to RECIST criteria Evidence of progression or primary manifestation (except osseous metastases and pleural effusion) No previous radiation therapy of the only measurable lesion No previous chemotherapy for metastatic disease; previous adjuvant chemotherapy is permitted if there was no progression of the disease within a period of 6 months Patients aged 60 years and beyond Written patient informed consent ECOG Status 0-2 Granulocytes >= 2 x 10**9/l and thrombocytes >= 100 x 10**/l Serum creatinine, bilirubin < 1.5 times the upper limit of normal value, albumin > 25 g/l No severe comorbidity including psychosis or any previous history of uncontrolled cardiovascular disease Normal left-ventricular function by echocardiography or MUGA scan No symptomatic CNS metastases Willingness to receive regular follow-up examinations Exclusion Criteria: Histological grading of malignancy: G I Histology of gastrointestinal stromal tumor, chondrosarcoma, uterine stromal sarcoma, mesothelioma, neuroblastoma, osteosarcoma, Ewing´s sarcoma/PNET, desmoplastic round cell tumor, embryonal rhabdomyosarcoma, alveolar soft tissue sarcoma Less than 5 years free of secondary malignancy except adequately treated carcinoma in situ (CIS) of the cervix, the bladder urothelium, basal cell carcinoma, or adenoma of the colon including pTIS, pTIN