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

Phase 2

• Conditions: Sarcoma, Soft Tissue
• Interventions: Drug: Adriamycin; Drug: Trofosfamide

• Registration Number: NCT00204568
• Lead Sponsor: University Hospital Schleswig-Holstein

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 adriamycin. In addition, the study is intended to investigate the level of toxicity associated with the two treatment regimens (safety profile).

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, 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)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-07
• Last Update Posted: 2013-01-08
• Primary Completion: 2013-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 117

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Adriamycin	Adriamycin mono
2	Trofosfamide	Trofosfamide

Primary Outcome Measures

Name	Time	Method
Progression-free survival after 6 months	after 6 months	Progression-free survival after 6 months

Secondary Outcome Measures

Name	Time	Method
Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival • Quality of life according to EORTC QLQ-30		Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival Quality of life according to EORTC QLQ-30

Trial Locations

Locations (1)

University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University; 🇩🇪 Kiel, Germany