Radiotherapy With Hyperthermia in Recurrent and Radiation-Induced Sarcomas

Recurrent Soft Tissue Sarcoma Clinical Trial

— HOT  

Official title:

Hyperthermia and Radiotherapy in the Treatment for In-field Recurrent and Radiation-induced Soft Tissue and Bone Sarcomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04398095
• Other study ID #: HOT1
• Status: Recruiting
• Phase: Phase 2
• Start date: October 23, 2019
• Est. completion date: April 2023

Study information

• Verified date: May 2020
• Source: Maria Sklodowska-Curie Institute - Oncology Center
• Contact: Mateusz J Spalek, MD PhD
• Phone: +48225462455
• Email: mateusz.spalek[@]pib-nio.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2023
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Poland	The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw	Warsaw	Mazovian

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Institute - Oncology Center

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Local control rate		18 months
Secondary	Progression-free survival		18 months
Secondary	Cancer-specific survival		18 months