Radiotherapy With Hyperthermia in Recurrent and Radiation-Induced Sarcomas

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Maria Sklodowska-Curie Institute - Oncology Center
Updated on 16 February 2024
cancer
ct scan
fever
sarcoma
MRI
blood test
soft tissue sarcoma
hyperthermia
hypofractionated radiation therapy
recurrent sarcoma
recurrent soft tissue sarcoma
radiation-induced cancer

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.

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.

Details
Condition Cancer, Neoplasms, Radiation-Induced, Recurrent Soft Tissue Sarcoma, Recurrent Sarcoma
Age 18years - 100years
Treatment hypofractionated radiotherapy, Hyperthermia
Clinical Study IdentifierNCT04398095
SponsorMaria Sklodowska-Curie Institute - Oncology Center
Last Modified on16 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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