Clinical trial · Interventional
Hyper-Thermia Enhanced Anti-tumor Efficacy of Trabectedin
Trabectedin Combined With Regional Hyperthermia as Second Line Treatment for Adult Patients With Advanced Soft-tissue Sarcoma
NCT02359474CI-TRIAL-00064317HyperTETunknownPhase 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)
This trial compares trabectedin alone to trabectedin in combination with regional hyperthermia in patients with high-risk soft tissue sarcoma. The study is designed to demonstrate a significant benefit for sarcoma-therapy by adding regional hyperthermia.
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 | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA double-strand breaks | Genetic | — | UNRESOLVED |
| Trabectedin | Drug | Trabectedin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Trabectedin with regional hyperthermia
- description
- Trabectedin 1.5 mg/m², 24 hrs continuous i.v. infusion, repetition after 21 days, until progress of disease. Additional treatment with regional hyperthermia (RHT): RHT treatment of the tumor area and the surrounding tissue (41-44°C for 60 min treatment time) is applied at the end of Trabectedin infusion (+/- 4 hrs).
- interventionNames
- Drug: Trabectedin
- Genetic: DNA double-strand breaks
- type
- ACTIVE_COMPARATOR
- label
- Trabectedin
- description
- Trabectedin 1.5 mg/m², 24 hrs continuous i.v. infusion, repetition after 21 days, until progress of disease.
- interventionNames
- Drug: Trabectedin
- Genetic: DNA double-strand breaks
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Histologically confirmed STS (primary or recurrent), except: Ewing sarcoma, osteosarcoma, skeletal chondrosarcoma (extraskeletal chondrosacomas are included), GIST, dermatofibrosarcoma protuberans, malignant mesothelioma, rhabdomyosarcoma * Patients after failure of first-line chemotherapy (anthracyclines with/without ifosfamide) with or without RHT * Progressive or recurrent tumor which is unresectable or only resectable with adverse functional outcome * After macroscopic incomplete resection or marginal resection (tumor-free margins \< 1 cm) * Prior chemotherapy, including anthracyclines with/without ifosfamide (with or without RHT) or patients who cannot be given these medicines * At least one tumor manifestation which is eligible for hyperthermia * Performance status (ECOG) 0,1 or 2 * More than 3 weeks from last treatment * Neutrophil count ≥ 1,5 G/l, hemoglobin ≥ 9 g/dl, platelets ≥ 100 G/l * Albumin ≥ 25 g/l, total bilirubin ≤ 1 x ULN, ALT/AST ≤ 2.5 x ULN, AP ≤ 2.5 x ULN, Cockroft and Gault's calculated creatinine clearance ≥ 30 ml/min, CPK ≤ 2.5 x ULN * Patients with the ability to follow study instructions and likely to attend and complete all required visits * Written informed consent of the subject Exclusion Criteria: * Uncontrolled infection (e.g. active viral hepatitis) * Unstable cardiac status * Peripheral neuropathy \> grade 2 * Known or persistent abuse of medications, drugs or alcohol * Other malignancy during the last 5 years (exclusion of basal cell carcinoma or adequately treated cervical carcinoma in situ) * Prior therapy with Tr or known history of hypersensitivity to drugs with a similar chemical structure * Pregnancy or breast-feeding * Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration * Uncontrolled CNS-metastases * Medical or technical impossibility for hyperthermia to heat the major target lesion
References
Publications (0)
Data not yet available
No reference posted for this study.