This trial is active, not recruiting.

Condition sarcoma, soft tissue
Treatments adriamycin, trofosfamide
Phase phase 2
Sponsor University of Schleswig-Holstein
Collaborator Arbeitsgemeinschaft fur Internistische Onkologie
Start date August 2004
End date October 2013
Trial size 117 participants
Trial identifier NCT00204568, jth_001


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Adriamycin mono
60 mg/m2, d1, W d22
300 mg absolute d1-7, followed by 150 mg absolute continuously

Primary Outcomes

Progression-free survival after 6 months
time frame: after 6 months

Secondary Outcomes

Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival • Quality of life according to EORTC QLQ-30
time frame:

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Randomized Phase II Trial of Trofosfamide vs. Adriamycin in Elderly Patients With Previously Untreated Metastatic Soft Tissue Sarcoma
Principal investigator Joerg T. Hartmann, MD
Description Group A:Adriamycin (60 mg/m2, d1, qd22) 75 mg/m2 may be applied instead of 60 mg/m2 for patients between 60 and 70 years of age (optional) Group B:Trofosfamide (300 mg absolute p.o. qd over 7 days, then 150 mg p.o. absolute qd continuously) In case of absence of any toxicity during treatment with trofosfamide 150 mg absolute a dose escalation to 200 mg absolute is allowed (optional)
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by University of Schleswig-Holstein.