Clinical trial · Interventional
Trofosfamide Versus Adriamycin in Elderly Patients With Soft Tissue Sarcoma (STS)
Randomized Phase II Trial of Trofosfamide vs. Adriamycin in Elderly Patients With Previously Untreated Metastatic Soft Tissue Sarcoma
NCT00204568CI-TRIAL-00008821unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma, Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriamycin | Drug | — | UNRESOLVED |
| Trofosfamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Adriamycin mono
- interventionNames
- Drug: Adriamycin
- type
- EXPERIMENTAL
- label
- 2
- description
- Trofosfamide
- interventionNames
- Drug: Trofosfamide
Primary outcomes (1)
- measure
- Progression-free survival after 6 months
- timeFrame
- after 6 months
- description
- Progression-free survival after 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.