Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03989596
Recruitment Status : Active, not recruiting
First Posted : June 18, 2019
Last Update Posted : February 1, 2021
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 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).

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 regional 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Radiotherapy With Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022


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. Feasibility of the treatment schedule [ Time Frame: Up to 3 months ]
    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%).


Secondary Outcome Measures :
  1. One-year local control rate [ Time Frame: 12 months after treatment completion ]
  2. One-year progression-free survival [ Time Frame: 12 months after treatment completion ]
  3. One-year sarcoma-specific survival [ Time Frame: 12 months after treatment completion ]
  4. Rate of late toxicities [ Time Frame: Two years after treatment completion ]
    Rate of late toxicities of a planned schedule of therapy according to CTCAE 5.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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

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
  • Distant 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


Locations
Layout table for location information
Poland
Maria Sklodowska-Curie Institute - Oncology Center
Warsaw, Mazovian, Poland, 02-781
Sponsors and Collaborators
Maria Sklodowska-Curie Institute - Oncology Center
Investigators
Layout table for investigator information
Principal Investigator: Mateusz J Spałek, MD PhD Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
Publications:
Layout table for additonal information
Responsible Party: Maria Sklodowska-Curie Institute - Oncology Center
ClinicalTrials.gov Identifier: NCT03989596    
Other Study ID Numbers: SINDIR1
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication as supplementary materials
Time Frame: Data will be available since a publication (as a study supplementary material)
Access Criteria: Based on journal policy, open access is preferred

Layout table for additional information
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:
Layout table for MeSH terms
Fever
Sarcoma
Rhabdomyosarcoma
Leiomyosarcoma
Liposarcoma
Sarcoma, Synovial
Nerve Sheath Neoplasms
Neurofibrosarcoma
Fibrosarcoma
Sarcoma, Alveolar Soft Part
Histiocytoma, Malignant Fibrous
Sarcoma, Clear Cell
Liposarcoma, Myxoid
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue
Body Temperature Changes
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
Histiocytoma