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

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ClinicalTrials.gov Identifier: NCT04398095
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Maria Sklodowska-Curie Institute - Oncology Center

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.

Condition or disease Intervention/treatment Phase
Radiation Induced Neoplasms Radiation-Induced Cancer Recurrent Sarcoma Recurrent Soft Tissue Sarcoma Radiation: Hypofractionated radiotherapy Other: Hyperthermia Radiation: Hypofractionated radiotherapy with boost Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperthermia and Radiotherapy in the Treatment for In-field Recurrent and Radiation-induced Soft Tissue and Bone Sarcomas
Actual Study Start Date : October 23, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2023


Arm Intervention/treatment
Experimental: Radiotherapy with hyperthermia in resectable sarcomas
12x 3 Gy (4 fractions per week) + hyperthermia (6x) + surgery
Radiation: Hypofractionated radiotherapy
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.

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

Experimental: Radiotherapy with hyperthermia in non-resectable sarcomas
12x 3 Gy with simultaneous integrated boost 3.5 Gy (4 fractions per week) + hyperthermia (6x)
Other: Hyperthermia
Deep hyperthermia (Celsius TCS or BSD-2000) according to local protocol combined with radiotherapy, twice a week.

Radiation: Hypofractionated radiotherapy with boost

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 Outcome Measures :
  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 Outcome Measures :
  1. Local control rate [ Time Frame: 18 months ]
  2. Progression-free survival [ Time Frame: 18 months ]
  3. Cancer-specific survival [ Time Frame: 18 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04398095


Contacts
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Contact: Mateusz J Spałek, MD PhD +48225462455 mateusz.spalek@pib-nio.pl
Contact: Aneta Borkowska, MD +48225462455 aneta.borkowska@pib-nio.pl

Locations
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Poland
The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw Recruiting
Warsaw, Mazovian, Poland, 02-781
Contact: Mateusz J Spałek, MD PhD    +48225462455    mateusz.spalek@pib-nio.pl   
Sub-Investigator: Aneta Borkowska, MD         
Principal Investigator: Mateusz J Spałek, MD PhD         
Sub-Investigator: Piotr Ł Rutkowski, MD PhD         
Sponsors and Collaborators
Maria Sklodowska-Curie Institute - Oncology Center
Investigators
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Principal Investigator: Mateusz J Spałek, MD PhD The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
Publications:
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Responsible Party: Maria Sklodowska-Curie Institute - Oncology Center
ClinicalTrials.gov Identifier: NCT04398095    
Other Study ID Numbers: HOT1
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Radiation-Induced
Fever
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Body Temperature Changes
Radiation Injuries
Wounds and Injuries