Status:
COMPLETED
Radiotherapy With Hyperthermia in Recurrent and Radiation-Induced Sarcomas
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Conditions:
Radiation Induced Neoplasms
Radiation-Induced Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Due to the rarity of radiation-induced (RIS) or previously irradiated recurrent (PIRS) sarcomas, no guidelines nor randomized prospective clinical trials on this topic exist. Thus the management of RI...
Eligibility Criteria
Inclusion
- Able to provide informed consent
- Eastern Cooperative Oncology Group performance status 0 - 2
- Age ≥18 years old
- Histologically-proven diagnosis of radiation-induced or recurrent soft tissue sarcoma
- Previous radiotherapy within the planned target volume
Exclusion
- Histologic diagnosis of rhabdomyosarcoma (except spindle cell and pleomorphic subtype), osteogenic sarcoma, Ewing's sarcoma/PNET, aggressive fibromatosis
- Contraindications to radiotherapy or hyperthermia
- Predicted unacceptable high risk of reirradiation-related toxicity, in the Investigator's judgment
- Unresectable metastases
Key Trial Info
Start Date :
October 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04398095
Start Date
October 23 2019
End Date
June 20 2023
Last Update
April 30 2025
Active Locations (1)
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1
The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
Warsaw, Mazovian, Poland, 02-781