Clinical trial · Interventional
Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)
Multicenter Phase II Study With Bendamustin for Patients With Refractory Soft Tissue Sarcoma
NCT00204620CI-TRIAL-00000693completedPhase 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 aims of this trial are to evaluate the efficacy of bendamustin in patients with metastatic soft tissue sarcoma who have progressed after or during an anthracycline-baesd chemotherapy and to assess the treatment of toxicity.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustin | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic or non-resectable soft tissue sarcoma * Evidence of progression or relapse after an anthracycline-based and/ or ifosfamide-based chemotherapy * At least 1 bidimensionally measurable tumor lesion according to RECIST criteria * No previous radiation therapy on the only measurable lesion * Willingness to receive regular follow-up * Life expectancy more than 3 months * ECOG status \>= 2 * Patients aged 18 years and beyond * leucocytes \> 2500/µl, thrombocytes \> 75000/µl) * Serum creatine \< 1,5 times the upper limit of normal value, GFR \> 60/ml * Written patient informed consent * Ability to give informed consent Exclusion Criteria: * Previous or concurrent radiation of the index lesion (radiation of single lesion is allowed if not the index lesion) * Insufficient liver function (bilirubin \> 1.5 the upper limit of normal, prolongation of PT and aPTT \> 1.5 the upper limit of normal; ASAT and ALAT \> 3 the upper limit of normal (patients with liver metastases ASAT and ALAT \> 5 the upper limit of normal) * Active infection * Prior therapy with Bendamustin hydrochloride * Prior malignancies (other than adequately treated carcinoma in situ (CIS) of the cervix, bladder urothelium, basal cell carcinoma or adenoma of the colon including pTIS,pTIN), unless treated with curative intent and without evidence of disease \> 5 years * Symptomatic cardio- and/or cerebrovascular disease (NYHA-Scale III°) * Interval since last chemotherapy \< 4 weeks * Evidence of CNS-metastases * Evidence of pregnancy or lactation * Woman of child-bearing potential without reliable methods of birth control
References
Publications (0)
Data not yet available
No reference posted for this study.