Sarcoma, Soft Tissue
Conditions
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)
Interventions
DRUGAdriamycin
60 mg/m2, d1, W d22
DRUGTrofosfamide
300 mg absolute d1-7, followed by 150 mg absolute continuously
Sponsors
Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group
French Sarcoma Group
University Hospital Schleswig-Holstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival after 6 months | after 6 months | Progression-free survival after 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed