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Preoperative Hypofractionated Radiotherapy With Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas (SINDIR)

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ClinicalTrials.gov Identifier: NCT03989596
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Sklodowska-Curie Institute - Oncology Center

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 deep hyperthermia (twice a week) within two weeks. The response analysis in CT or DWI-MRI and toxicity assessment will be performed after 6 weeks. On the second MDT meeting, a final decision about resectability of the tumor will be made. In case of resectability, a patient will be referred to surgery. In case of unresectability the patient will receive a boost which consists of 4x 4 Gy with deep hyperthermia (twice a week).

Condition or disease Intervention/treatment Phase
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 Radiation: Hypofractionated radiotherapy Other: Hyperthermia Phase 2

Detailed Description:

There is a lack of standard treatment of unresectable and marginally resectable sarcomas. Results of commonly used approaches are unsatisfactory, especially in patients who are not candidates for neoadjuvant chemotherapy due to poor performance status, comorbidities, radioresistant pathology or disease progression on the commonly used chemotherapy regimens. The addition of deep hyperthermia to irradiation and in the prolonged gap between the end of hypofractionated 10x 3.25 Gy radiotherapy and surgery may allow obtaining the long-term local control with the maintenance of a good treatment tolerance.

Hypofractionation represents a variation of radiotherapy fractionation in which the total dose is divided into fewer fractions with an increased fraction dose. Such treatment may lead to additional biological effects when compared to conventionally fractionated radiotherapy (eg. vascular damage, increased immunogenicity, and antigenicity). The main advantages of hypofractionation are those related to the decreased overall treatment time which is more convenient for both patients and physicians, increased compliance and makes the treatment more cost-effective. Intriguing, such an approach may provide an additional benefit when treating non-radiosensitive tumors with a low alpha/beta ratio (eg. sarcomas).

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. The treatment tolerance is usually very good.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Hypofractionated Radiotherapy With Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2021


Arm Intervention/treatment
Experimental: Radiotherapy with hyperthermia
10x 3.25 Gy + hyperthermia + surgery or radiotherapy boost (4x 4 Gy + hyperthermia)
Radiation: Hypofractionated radiotherapy

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.


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




Primary Outcome Measures :
  1. Rate of grade 3 or higher early toxicity of planned schedule of therapy according to RTOG/EORTC scale [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. One-year local control rate [ Time Frame: 24 months ]
  2. One-year progression-free survival [ Time Frame: 24 months ]
  3. One-year cancer-specific survival [ Time Frame: 24 months ]
  4. Rate of late treatment toxicity, at 6 and 12 months, according to RTOG/EORTC scale [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to provide informed consent; age ≥18 years old
  • Eastern Cooperative Oncology Group performance status 0 - 2
  • Histologic diagnosis of soft tissue sarcoma
  • Age > 70 years, or ten-year survival <40% as predicted in Charlson Comorbidity Index, or non-operability from other reasons, or chemoresistant tumor (histology or progression after neoadjuvant chemotherapy)

Exclusion Criteria:

  • 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
  • Unresectable metastases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989596


Contacts
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Contact: Mateusz J Spałek, MD +48225462455 mateusz.spalek@coi.pl
Contact: Aneta Borkowska, MD +48225462455 aneta.borkowska@coi.pl

Locations
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Poland
Maria Sklodowska-Curie Institute - Oncology Center Recruiting
Warsaw, Mazovian, Poland, 02-781
Contact: Piotr Rutkowski, MD PhD Professor    +48226439375    piotr.rutkowski@coi.pl   
Principal Investigator: Mateusz J Spałek, MD         
Sub-Investigator: Aneta Borkowska, MD         
Sub-Investigator: Tadeusz Morysiński, MD PhD         
Sub-Investigator: Konrad Pawlewicz, MD         
Sub-Investigator: Dorota Kiprian, MD PhD         
Sub-Investigator: Klaudia Lewcio-Szczęsna, MSc         
Sub-Investigator: Daria Niebyłowska, MSc         
Sub-Investigator: Maria Telejko, MSc         
Sub-Investigator: Maciej Kawecki, MD         
Sub-Investigator: Piotr Rutkowski, MD PhD Professor         
Sponsors and Collaborators
Maria Sklodowska-Curie Institute - Oncology Center

Publications:
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Responsible Party: Maria Sklodowska-Curie Institute - Oncology Center
ClinicalTrials.gov Identifier: NCT03989596     History of Changes
Other Study ID Numbers: SINDIR1
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maria Sklodowska-Curie Institute - Oncology Center:
Dose Hypofractionation
Neoadjuvant Therapy
Sarcoma
Hyperthermia
Dose Fractionation

Additional relevant MeSH terms:
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Sarcoma
Rhabdomyosarcoma
Leiomyosarcoma
Fever
Liposarcoma
Sarcoma, Synovial
Nerve Sheath Neoplasms
Sarcoma, Alveolar Soft Part
Fibrosarcoma
Neurofibrosarcoma
Sarcoma, Clear Cell
Histiocytoma, Malignant Fibrous
Liposarcoma, Myxoid
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue
Body Temperature Changes
Signs and Symptoms
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue
Neoplasms, Nerve Tissue
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neoplasms, Fibrous Tissue
Neurofibroma