Status:
UNKNOWN
Trofosfamide Versus Adriamycin in Elderly Patients With Soft Tissue Sarcoma (STS)
Lead Sponsor:
University Hospital Schleswig-Holstein
Collaborating Sponsors:
Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group
Conditions:
Sarcoma, Soft Tissue
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief 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 ad...
Detailed 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, th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2013
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00204568
Start Date
August 1 2004
End Date
October 1 2013
Last Update
January 8 2013
Active Locations (1)
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1
University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University
Kiel, Germany, 24105