Hypofractionated Radiotherapy With Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas

NCT03989596 | Unknown Phase 2

• 1 other identifier: SINDIR1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 will receive the hypofractionated radiotherapy 10x 3.25 Gy with regional hyperthermia (twice a week) within two weeks. The response analysis in CT or DWI-MRI and toxicity assessment will be performed after at least 6 weeks. At the second MDT meeting, a final decision about resectability of the tumor will be made. In case of resectability or consent for amputation, if required, a patient will be referred to surgery. In case of unresectability or amputation refusal, the patient will receive the second part of the treatment which consists of 4x 4 Gy with hyperthermia (twice a week).

Conditions

Sarcoma; Alveolar Soft Part Sarcoma; Clear Cell Sarcoma; Malignant Peripheral Nerve Sheath Tumors; Myxoid Liposarcoma; Liposarcoma, Dedifferentiated; Synovial Sarcoma; Leiomyosarcoma; Undifferentiated Pleomorphic Sarcoma; Fibrosarcoma; Pleomorphic Rhabdomyosarcoma

Keywords

Dose Hypofractionation; Neoadjuvant Therapy; Sarcoma; Hyperthermia; Dose Fractionation

Outcome Measures

Primary Outcomes (1)

• Feasibility of the treatment schedule

  The exact 95% confidence interval for an estimated feasibility proportion of 80% (23 of 30 patients) does not include (60-80%) a value of 50%. Thus, for a sample size of 30 patients, the feasibility of 80% is above chance level performance (50%).

  Up to 3 months

Secondary Outcomes (4)

• One-year local control rate

  12 months after treatment completion

• One-year progression-free survival

  12 months after treatment completion

• One-year sarcoma-specific survival

  12 months after treatment completion

• Rate of late toxicities

  Two years after treatment completion

Study Arms (1)

Radiotherapy with hyperthermia

EXPERIMENTAL

10x 3.25 Gy + hyperthermia + surgery or radiotherapy boost (4x 4 Gy + hyperthermia)

Radiation: Hypofractionated radiotherapy; Other: Hyperthermia

Interventions

Hypofractionated radiotherapy RADIATION

Preoperative hypofractionated 10x 3.25 Gy radiotherapy (5 consecutive days in a week, two 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 boost 4x 4 Gy within one week in case of unresectability after 6 weeks.

Radiotherapy with hyperthermia

Hyperthermia OTHER

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

Radiotherapy with hyperthermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent; age ≥18 years old
• Eastern Cooperative Oncology Group performance status 0 - 2
• Histologic diagnosis of locally advanced soft tissue sarcoma
• Marginally resectable or unresectable tumor (assessed at Multidisciplinary Tumor Board)
• Radioresistant sarcoma subtype (low-grade tumor or radioresistant histology) or contradictions to chemotherapy (assessed at Multidisciplinary Tumor Board) or progression after neoadjuvant chemotherapy

You may not qualify if:

• Radiation-induced sarcoma or previous radiation to the affected volume
• Histologic diagnosis of rhabdomyosarcoma (except pleomorphic subtype), osteogenic sarcoma, Ewing's sarcoma/PNET, aggressive fibromatosis
• Contraindications to radiotherapy or hyperthermia
• Distant metastases

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

Maria Sklodowska-Curie Institute - Oncology Center

Warsaw, Mazovian, 02-781, Poland

Location

Related Publications (3)

• 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: 25282099 BACKGROUND

• 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: 21360087 BACKGROUND

• Pennacchioli E, Fiore M, Gronchi A. Hyperthermia as an adjunctive treatment for soft-tissue sarcoma. Expert Rev Anticancer Ther. 2009 Feb;9(2):199-210. doi: 10.1586/14737140.9.2.199.

  PMID: 19192958 BACKGROUND

MeSH Terms

Conditions

Sarcoma; Sarcoma, Alveolar Soft Part; Sarcoma, Clear Cell; Neurofibrosarcoma; Liposarcoma, Myxoid; Liposarcoma; Sarcoma, Synovial; Leiomyosarcoma; Histiocytoma, Malignant Fibrous; Fibrosarcoma; Hyperthermia

Interventions

Radiation Dose Hypofractionation; Diathermy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neoplasms, Adipose Tissue; Histiocytoma; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics; Hyperthermia, Induced

Study Officials

• Mateusz J Spałek, MD PhD

  Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: June 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: February 1, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available since a publication (as a study supplementary material)
• Access Criteria: Based on journal policy, open access is preferred

Locations

PL (1)