Hypofractionated Radiotherapy With Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas (SINDIR)
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|ClinicalTrials.gov Identifier: NCT03989596|
Recruitment Status : Unknown
Verified December 2020 by Maria Sklodowska-Curie National Research Institute of Oncology.
Recruitment status was: Active, not recruiting
First Posted : June 18, 2019
Last Update Posted : February 1, 2021
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|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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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|
|Responsible Party:||Maria Sklodowska-Curie National Research Institute of Oncology|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Nerve Sheath Neoplasms
Sarcoma, Alveolar Soft Part
Histiocytoma, Malignant Fibrous
Sarcoma, Clear Cell
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue
Neoplasms, Nerve Tissue
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases