Radiotherapy With Hyperthermia in Recurrent and Radiation-Induced Sarcomas
- Conditions
- Radiation-Induced CancerRecurrent SarcomaRecurrent Soft Tissue SarcomaRadiation Induced Neoplasms
- Interventions
- Other: HyperthermiaRadiation: Hypofractionated radiotherapyRadiation: Hypofractionated radiotherapy with boost
- Registration Number
- NCT04398095
- 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 on Multidisciplinary Team (MDT) meeting, a patient with radiation-induced or in-field recurrent sarcoma will receive the hypofractionated radiotherapy with deep hyperthermia (twice a week) within three weeks. The response analysis in CT or DWI-MRI and toxicity assessment will be performed after 6 weeks. In resectable tumors, a patient will be referred to surgery. In the case of unresectability, the patient will followed-up.
- 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 RIS and PIR is challenging. The only curable modality in non-metastatic RIS/PIRS is radical resection with wide negative margins. The role of secondary radiotherapy in locally advanced RIS/PIRS is unclear, mostly due to the concerns about possible severe side effects after re-irradiation.
The addition of deep hyperthermia to irradiation and in the prolonged gap between the end of moderately hypofractionated radiotherapy (with or without integrated boost) and surgery may allow obtaining the long-term local control with the maintenance of a good treatment tolerance Hyperthermia is a method of increasing the temperature in the tumor to damage cancer cells with minimum injury to the normal cells. It should be combined with another treatment modality (radio- or chemotherapy) rather than used alone. Its efficacy was proven in clinical trials. Treatment tolerance is usually very good.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radiotherapy with hyperthermia in non-resectable sarcomas Hyperthermia 12x 3 Gy with simultaneous integrated boost 3.5 Gy (4 fractions per week) + hyperthermia (6x) Radiotherapy with hyperthermia in resectable sarcomas Hypofractionated radiotherapy 12x 3 Gy (4 fractions per week) + hyperthermia (6x) + surgery Radiotherapy with hyperthermia in resectable sarcomas Hyperthermia 12x 3 Gy (4 fractions per week) + hyperthermia (6x) + surgery Radiotherapy with hyperthermia in non-resectable sarcomas Hypofractionated radiotherapy with boost 12x 3 Gy with simultaneous integrated boost 3.5 Gy (4 fractions per week) + hyperthermia (6x)
- Primary Outcome Measures
Name Time Method Ratio of late adverse events 18 months Ratio of grade 3 or higher late adverse events related to reirradiation, according to CTCAE 5.0
- Secondary Outcome Measures
Name Time Method Local control rate 18 months Cancer-specific survival 18 months Progression-free survival 18 months
Trial Locations
- Locations (1)
The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
🇵🇱Warsaw, Mazovian, Poland