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NCT Number: NCT04398095

Radiotherapy With Hyperthermia in Recurrent and Radiation-Induced Sarcomas

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.

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Key information

Conditions

Radiation Induced Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Radiation-Induced Radiation Injuries Radiation-Induced Cancer Recurrent Sarcoma Recurrent Soft Tissue Sarcoma Sarcoma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw

Warsaw, Mazovian, 02-781, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypofractionated radiotherapy

Radiation

Resectable or marginally resectable tumors: preoperative hypofractionated 12x 3 Gy radiotherapy (4 days in a week, three weeks) prescribed on planned target volume (tumor volume + elective margins + setup/error margin) with daily image guidance with cone beam-CT or kV-portal position verification.

Hyperthermia

Other

Deep hyperthermia (Celsius TCS or BSD-2000) according to local protocol combined with radiotherapy, twice a week.

Hypofractionated radiotherapy with boost

Radiation

Non-resectable/inoperable tumors: definitive hypofractionated 12x 3 Gy radiotherapy prescribed on planned target volume (tumor volume + elective margins + setup/error margin) with simultaneous integrated boost 3.5 Gy per fraction prescribed on boost planned target volume (tumor volume + setup/error margin), 4 days in a week, three weeks.

Radiotherapy with daily image guidance with cone beam-CT or kV-portal position verification.

Primary outcomes

  1. Ratio of late adverse events

    Time frame: 18 months

    Ratio of grade 3 or higher late adverse events related to reirradiation, according to CTCAE 5.0

Secondary outcomes

  1. Local control rate

    Time frame: 18 months

  2. Progression-free survival

    Time frame: 18 months

  3. Cancer-specific survival

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Registry information

Official study title

Hyperthermia and Radiotherapy in the Treatment for In-field Recurrent and Radiation-induced Soft Tissue and Bone Sarcomas

Acronym: HOT

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 21, 2020
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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