Clinical trial · Interventional
Hypofractionated Radiotherapy With Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas
- 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)
After a screening, which consists of biopsy, physical examination, initial diffusion-weighted magnetic resonance imaging (DWI-MRI) or body computed tomography (CT) scan, blood tests and case analysis on Multidisciplinary Team (MDT) meeting, a patient will receive the hypofractionated radiotherapy 10x 3.25 Gy with regional hyperthermia (twice a week) within two weeks. The response analysis in CT or DWI-MRI and toxicity assessment will be performed after at least 6 weeks. At the second MDT meeting, a final decision about resectability of the tumor will be made. In case of resectability or consent for amputation, if required, a patient will be referred to surgery. In case of unresectability or amputation refusal, the patient will receive the second part of the treatment which consists of 4x 4 Gy with hyperthermia (twice a week).
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alveolar Soft Part Sarcoma | Alveolar Soft Part Sarcoma | ONTOLOGY_EXACT | 0.90 |
| Clear Cell Sarcoma | Clear Cell Sarcoma of Soft Tissue | ALIAS | 0.90 |
| Fibrosarcoma | Fibrosarcoma | ONTOLOGY_EXACT | 0.90 |
| Leiomyosarcoma | Leiomyosarcoma | ONTOLOGY_EXACT | 0.90 |
| Liposarcoma, Dedifferentiated | Dedifferentiated Liposarcoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Peripheral Nerve Sheath Tumors | Malignant Peripheral Nerve Sheath Tumor | ONTOLOGY_EXACT | 0.90 |
| Myxoid Liposarcoma | Myxoid Liposarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermia | Other | — | UNRESOLVED |
| Hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy with hyperthermia
- description
- 10x 3.25 Gy + hyperthermia + surgery or radiotherapy boost (4x 4 Gy + hyperthermia)
- interventionNames
- Radiation: Hypofractionated radiotherapy
- Other: Hyperthermia
Primary outcomes (1)
- measure
- Feasibility of the treatment schedule
- timeFrame
- Up to 3 months
- description
- The exact 95% confidence interval for an estimated feasibility proportion of 80% (23 of 30 patients) does not include (60-80%) a value of 50%. Thus, for a sample size of 30 patients, the feasibility of 80% is above chance level performance (50%).
Secondary outcomes (4)
- measure
- One-year local control rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Able to provide informed consent; age ≥18 years old * Eastern Cooperative Oncology Group performance status 0 - 2 * Histologic diagnosis of locally advanced soft tissue sarcoma * Marginally resectable or unresectable tumor (assessed at Multidisciplinary Tumor Board) * Radioresistant sarcoma subtype (low-grade tumor or radioresistant histology) or contradictions to chemotherapy (assessed at Multidisciplinary Tumor Board) or progression after neoadjuvant chemotherapy Exclusion Criteria: * Radiation-induced sarcoma or previous radiation to the affected volume * Histologic diagnosis of rhabdomyosarcoma (except pleomorphic subtype), osteogenic sarcoma, Ewing's sarcoma/PNET, aggressive fibromatosis * Contraindications to radiotherapy or hyperthermia * Distant metastases
References
Publications (3)
- BACKGROUNDKosela-Paterczyk H, Szacht M, Morysinski T, Lugowska I, Dziewirski W, Falkowski S, Zdzienicki M, Pienkowski A, Szamotulska K, Switaj T, Rutkowski P. Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas. Eur J Surg Oncol. 2014 Dec;40(12):1641-7. doi: 10.1016/j.ejso.2014.05.016. Epub 2014 Sep 20. PMID 25282099
- BACKGROUNDLindner LH, Issels RD. Hyperthermia in soft tissue sarcoma. Curr Treat Options Oncol. 2011 Mar;12(1):12-20. doi: 10.1007/s11864-011-0144-6. PMID 21360087
- BACKGROUNDPennacchioli E, Fiore M, Gronchi A. Hyperthermia as an adjunctive treatment for soft-tissue sarcoma. Expert Rev Anticancer Ther. 2009 Feb;9(2):199-210. doi: 10.1586/14737140.9.2.199. PMID 19192958