Clinical trial NCT00204568: Trofosfamide Versus Adriamycin in Elderly Patients With Soft Tissue Sarcoma (STS)
Official title: Randomized Phase II Trial of Trofosfamide vs. Adriamycin in Elderly Patients With Previously Untreated Metastatic Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sarcoma, Soft Tissue
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Arbeitsgemeinschaft fur Internistische Onkologie
name: German Sarcoma Group
name: French Sarcoma Group
First posted: 2005-09-20
Enrollment: 117
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Progression-free survival after 6 months
timeFrame: after 6 months
Secondary outcomes:
measure: Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival • Quality of life according to EORTC QLQ-30
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University
Study officials:
affiliation: University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University
name: Joerg T. Hartmann, MD
role: PRINCIPAL_INVESTIGATOR
References: