NCT03989596: SINDIR

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

Status unknown Phase 2 Last updated 1 February 2021

What this trial tests

Phase 2 trial testing Hypofractionated radiotherapy in Sarcoma in 30 participants. Status unknown.

Timeline

1 June 2018

Primary endpoint
31 December 2020

31 December 2022

Quick facts

Lead sponsor	Maria Sklodowska-Curie National Research Institute of Oncology
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 June 2018
Primary completion	31 December 2020
Estimated completion	31 December 2022
Sites	1 location across Poland

Drugs / interventions tested

• Hypofractionated radiotherapy
• Hyperthermia

Conditions studied

• Sarcoma — all drugs for Sarcoma →
• Alveolar Soft Part Sarcoma — all drugs for Alveolar Soft Part Sarcoma →
• Clear Cell Sarcoma — all drugs for Clear Cell Sarcoma →
• Malignant Peripheral Nerve Sheath Tumors — all drugs for Malignant Peripheral Nerve Sheath Tumors →

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Who can join

18 and older, any sex, with Sarcoma or Alveolar Soft Part Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neoadjuvant Treatment Options in Soft Tissue Sarcomas.
   Spałek MJ, Kozak K, Czarnecka AM, Bartnik E, et al · · 2020 · cited 28× · PMID 32722580 · DOI 10.3390/cancers12082061
2. The current management of alveolar soft part sarcomas.
   Chang X, Li Y, Xue X, Zhou H, et al · · 2021 · cited 14× · PMID 34397835 · DOI 10.1097/md.0000000000026805
3. The Feasibility Study of Hypofractionated Radiotherapy with Regional Hyperthermia in Soft Tissue Sarcomas.
   Spałek MJ, Borkowska AM, Telejko M, Wągrodzki M, et al · · 2021 · cited 14× · PMID 33809547 · DOI 10.3390/cancers13061332
4. Evaluating Thresholds to Adopt Hypofractionated Preoperative Radiotherapy as Standard of Care in Sarcoma.
   Valle LF, Bernthal N, Eilber FC, Shabason JE, et al · · 2021 · cited 9× · PMID 34720663 · DOI 10.1155/2021/3735874
5. The role of radiotherapy in adult soft tissues sarcoma of the extremities.
   Cammelli S, Cortesi A, Buwenge M, Zamagni A, et al · · 2021 · cited 9× · PMID 33954820 · DOI 10.1007/s00590-021-02990-6