Trofosfamide Versus Adriamycin in Elderly Patients With Soft Tissue Sarcoma (STS)
This trial is active, not recruiting.
|Condition||sarcoma, soft tissue|
|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).
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Progression-free survival after 6 months
time frame: after 6 months
Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival • Quality of life according to EORTC QLQ-30
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
|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)|
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