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Radiotherapy With Hyperthermia in Recurrent and Radiation-Induced Sarcomas

NCT04398095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-30

No results posted yet for this study

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.

Conditions

  • Radiation Induced Neoplasms
  • Radiation-Induced Cancer
  • Recurrent Sarcoma
  • Recurrent Soft Tissue Sarcoma

Interventions

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.

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.

Sponsors & Collaborators

  • Maria Sklodowska-Curie National Research Institute of Oncology

    lead OTHER

Principal Investigators

  • Mateusz J Spałek, MD PhD · The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-23
Primary Completion
2023-06-20
Completion
2023-06-20

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04398095 on ClinicalTrials.gov