Radiotherapy With Hyperthermia in Recurrent and Radiation-Induced Sarcomas (HOT)

Maria Sklodowska-Curie National Research Institute of Oncology

Status: Completed

Conditions: Radiation Induced Neoplasms; Radiation-Induced Cancer; Recurrent Soft Tissue Sarcoma; Recurrent Sarcoma

Treatments: Other: Hyperthermia; Radiation: Hypofractionated radiotherapy with boost; Radiation: Hypofractionated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04398095

HOT1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Radiotherapy with hyperthermia in resectable sarcomas

Experimental group

Description:

12x 3 Gy (4 fractions per week) + hyperthermia (6x) + surgery

Treatment:

Radiation: Hypofractionated radiotherapy

Other: Hyperthermia

Radiotherapy with hyperthermia in non-resectable sarcomas

Experimental group

Description:

12x 3 Gy with simultaneous integrated boost 3.5 Gy (4 fractions per week) + hyperthermia (6x)

Treatment:

Radiation: Hypofractionated radiotherapy with boost

Other: Hyperthermia