Hypofractionated Radiotherapy With Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas (SINDIR)
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|ClinicalTrials.gov Identifier: NCT03989596|
Recruitment Status : Active, not recruiting
First Posted : June 18, 2019
Last Update Posted : February 1, 2021
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Deep hyperthermia (Celsius TCS or BSD-2000) according to local protocol combined with radiotherapy, twice a week.
- 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%).
- One-year local control rate [ Time Frame: 12 months after treatment completion ]
- One-year progression-free survival [ Time Frame: 12 months after treatment completion ]
- One-year sarcoma-specific survival [ Time Frame: 12 months after treatment completion ]
- 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
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
|Maria Sklodowska-Curie Institute - Oncology Center|
|Warsaw, Mazovian, Poland, 02-781|
|Principal Investigator:||Mateusz J Spałek, MD PhD||Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw|