Radiotherapy With Hyperthermia in Recurrent and Radiation-Induced Sarcomas
NCT ID: NCT04398095
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2019-10-23
2023-06-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiotherapy with hyperthermia in resectable sarcomas
12x 3 Gy (4 fractions per week) + hyperthermia (6x) + surgery
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.
Hyperthermia
Deep hyperthermia (Celsius TCS or BSD-2000) according to local protocol combined with radiotherapy, twice a week.
Radiotherapy with hyperthermia in non-resectable sarcomas
12x 3 Gy with simultaneous integrated boost 3.5 Gy (4 fractions per week) + hyperthermia (6x)
Hyperthermia
Deep hyperthermia (Celsius TCS or BSD-2000) according to local protocol combined with radiotherapy, twice a week.
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.
Interventions
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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.
Hyperthermia
Deep hyperthermia (Celsius TCS or BSD-2000) according to local protocol combined with radiotherapy, twice a week.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Contraindications to radiotherapy or hyperthermia
* Predicted unacceptable high risk of reirradiation-related toxicity, in the Investigator's judgment
* Unresectable metastases
18 Years
ALL
No
Sponsors
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Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Mateusz J Spałek, MD PhD
Role: PRINCIPAL_INVESTIGATOR
The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
Locations
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The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
Warsaw, Mazovian, Poland
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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HOT1
Identifier Type: -
Identifier Source: org_study_id
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