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

NCT ID: NCT00204568

Last Updated: 2013-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2013-10-31

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)

Conditions

Sarcoma, Soft Tissue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Adriamycin mono

Group Type: ACTIVE_COMPARATOR

Adriamycin

Intervention Type: DRUG

60 mg/m2, d1, W d22

2

Trofosfamide

Group Type: EXPERIMENTAL

Trofosfamide

Intervention Type: DRUG

300 mg absolute d1-7, followed by 150 mg absolute continuously

Interventions

Adriamycin

60 mg/m2, d1, W d22

Intervention Type: DRUG

Trofosfamide

300 mg absolute d1-7, followed by 150 mg absolute continuously

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arbeitsgemeinschaft fur Internistische Onkologie

OTHER

Sponsor Role: collaborator

German Sarcoma Group

OTHER

Sponsor Role: collaborator

French Sarcoma Group

OTHER

Sponsor Role: collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

J. T. Hartmann

Prof. Dr. med. J. T. Hartmann

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joerg T. Hartmann, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University

Locations

University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University

Kiel, , Germany

Countries

Germany

Other Identifiers

jth_001

Identifier Type: -

Identifier Source: org_study_id