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

• Status: Unknown status
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this trial is to determine whether oral continuous (metronomic) therapy with trofosfamide results in a similar rate of progression-free time after 6 months as intravenous treatment with adriamycin. In addition, the study is intended to investigate the level of toxicity associated with the two treatment regimens (safety profile).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Schleswig-Holstein; University of Schleswig-Holstein
• Collaborators: Arbeitsgemeinschaft fur Internistische Onkologie; French Sarcoma Group; German Sarcoma Group
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Trofosfamide

Criteria

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