NCT04398095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

April 30, 2025

Status Verified

May 1, 2020

Enrollment Period

3.7 years

First QC Date

May 18, 2020

Last Update Submit

April 27, 2025

Conditions

Radiation Induced NeoplasmsRadiation-Induced CancerRecurrent SarcomaRecurrent Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

  • Ratio of late adverse events

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

    18 months

Secondary Outcomes (3)

  • Local control rate

    18 months

  • Progression-free survival

    18 months

  • Cancer-specific survival

    18 months

Study Arms (2)

Radiotherapy with hyperthermia in resectable sarcomas

EXPERIMENTAL

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

Radiation: Hypofractionated radiotherapyOther: Hyperthermia

Radiotherapy with hyperthermia in non-resectable sarcomas

EXPERIMENTAL

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

Other: HyperthermiaRadiation: Hypofractionated radiotherapy with boost

Interventions

Hypofractionated radiotherapyRADIATION

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.

Radiotherapy with hyperthermia in resectable sarcomas
HyperthermiaOTHER

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

Radiotherapy with hyperthermia in non-resectable sarcomasRadiotherapy with hyperthermia in resectable sarcomas
Hypofractionated radiotherapy with boostRADIATION

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.

Radiotherapy with hyperthermia in non-resectable sarcomas

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Warsaw, Mazovian, 02-781, Poland

Location

Related Publications (5)

  • de Jong MA, Oldenborg S, Bing Oei S, Griesdoorn V, Kolff MW, Koning CC, van Tienhoven G. Reirradiation and hyperthermia for radiation-associated sarcoma. Cancer. 2012 Jan 1;118(1):180-7. doi: 10.1002/cncr.26252. Epub 2011 Jun 28.

    PMID: 21713762BACKGROUND

  • Haas RL, Miah AB, LePechoux C, DeLaney TF, Baldini EH, Alektiar K, O'Sullivan B. Preoperative radiotherapy for extremity soft tissue sarcoma; past, present and future perspectives on dose fractionation regimens and combined modality strategies. Radiother Oncol. 2016 Apr;119(1):14-21. doi: 10.1016/j.radonc.2015.12.002. Epub 2015 Dec 21.

    PMID: 26718153BACKGROUND

  • Kosela-Paterczyk H, Szacht M, Morysinski T, Lugowska I, Dziewirski W, Falkowski S, Zdzienicki M, Pienkowski A, Szamotulska K, Switaj T, Rutkowski P. Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas. Eur J Surg Oncol. 2014 Dec;40(12):1641-7. doi: 10.1016/j.ejso.2014.05.016. Epub 2014 Sep 20.

    PMID: 25282099BACKGROUND

  • Lindner LH, Issels RD. Hyperthermia in soft tissue sarcoma. Curr Treat Options Oncol. 2011 Mar;12(1):12-20. doi: 10.1007/s11864-011-0144-6.

    PMID: 21360087BACKGROUND

  • Borghede G, Hedelin H. Radiotherapy of localised prostate cancer. Analysis of late treatment complications. A prospective study. Radiother Oncol. 1997 May;43(2):139-46. doi: 10.1016/s0167-8140(96)01871-3.

    PMID: 9192958BACKGROUND

MeSH Terms

Conditions

Neoplasms, Radiation-InducedSarcoma

Interventions

Radiation Dose HypofractionationDiathermy

Condition Hierarchy (Ancestors)

NeoplasmsRadiation InjuriesWounds and InjuriesNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Dose Fractionation, RadiationRadiotherapy DosageRadiotherapyTherapeuticsHyperthermia, Induced

Study Officials

  • Mateusz J Spałek, MD PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 21, 2020

Study Start

October 23, 2019

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

April 30, 2025

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations

PL(1)