NCT04398095: HOT

Radiotherapy With Hyperthermia in Recurrent and Radiation-Induced Sarcomas

Completed NA Last updated 30 April 2025

What this trial tests

NA trial testing Hypofractionated radiotherapy in Radiation Induced Neoplasms in 20 participants. Completed in 20 June 2023.

Timeline

23 October 2019

Primary endpoint
20 June 2023

20 June 2023

Quick facts

Lead sponsor	Maria Sklodowska-Curie National Research Institute of Oncology
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	23 October 2019
Primary completion	20 June 2023
Estimated completion	20 June 2023
Sites	1 location across Poland

Drugs / interventions tested

• Hypofractionated radiotherapy
• Hyperthermia
• Hypofractionated radiotherapy with boost

Conditions studied

• Radiation Induced Neoplasms — all drugs for Radiation Induced Neoplasms →
• Radiation-Induced Cancer — all drugs for Radiation-Induced Cancer →
• Recurrent Sarcoma — all drugs for Recurrent Sarcoma →
• Recurrent Soft Tissue Sarcoma — all drugs for Recurrent Soft Tissue Sarcoma →

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Who can join

18 and older, any sex, with Radiation Induced Neoplasms or Radiation-Induced Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neoadjuvant Treatment Options in Soft Tissue Sarcomas.
   Spałek MJ, Kozak K, Czarnecka AM, Bartnik E, et al · · 2020 · cited 28× · PMID 32722580 · DOI 10.3390/cancers12082061
2. The Management of Radiation-Induced Sarcomas: A Cohort Analysis from a Sarcoma Tertiary Center.
   Spałek MJ, Czarnecka AM, Rutkowski P. · · 2021 · cited 16× · PMID 33578934 · DOI 10.3390/jcm10040694
3. Radiotherapy in bone sarcoma: the quest for better treatment option.
   Locquet MA, Brahmi M, Blay JY, Dutour A. · · 2023 · cited 15× · PMID 37563551 · DOI 10.1186/s12885-023-11232-3
4. Evaluating Thresholds to Adopt Hypofractionated Preoperative Radiotherapy as Standard of Care in Sarcoma.
   Valle LF, Bernthal N, Eilber FC, Shabason JE, et al · · 2021 · cited 9× · PMID 34720663 · DOI 10.1155/2021/3735874
5. Hypofractionated radiotherapy with hyperthermia in radiation-associated and in-volume recurrent soft tissue sarcomas of the extremities and trunk wall: results of a proof-of-concept prospective trial.
   Zasadziński K, Borkowska A, Kopeć D, Telejko M, et al · · 2025 · cited 1× · PMID 41310692 · DOI 10.1186/s13014-025-02772-y
6. The role of hyperthermia in modern radiation treatment- state of art.
   Borkowska A, Chmiel P, Rutkowski P, Spałek MJ. · · 2025 · PMID 41390436 · DOI 10.1186/s13014-025-02741-5