Recurrent Soft Tissue Sarcoma Clinical Trial
— HOTOfficial title:
Hyperthermia and Radiotherapy in the Treatment for In-field Recurrent and Radiation-induced Soft Tissue and Bone Sarcomas
NCT number | NCT04398095 |
Other study ID # | HOT1 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | October 23, 2019 |
Est. completion date | April 2023 |
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 with radiation-induced or in-field recurrent sarcoma will receive the hypofractionated radiotherapy with deep hyperthermia (twice a week) within three weeks. The response analysis in CT or DWI-MRI and toxicity assessment will be performed after 6 weeks. In resectable tumors, a patient will be referred to surgery. In the case of unresectability, the patient will followed-up.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | April 2023 |
Est. primary completion date | April 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Able to provide informed consent - Eastern Cooperative Oncology Group performance status 0 - 2 - Age =18 years old - Histologically-proven diagnosis of radiation-induced or recurrent soft tissue sarcoma - Previous radiotherapy within the planned target volume Exclusion Criteria: - Histologic diagnosis of rhabdomyosarcoma (except spindle cell and pleomorphic subtype), osteogenic sarcoma, Ewing's sarcoma/PNET, aggressive fibromatosis - Contraindications to radiotherapy or hyperthermia - Predicted unacceptable high risk of reirradiation-related toxicity, in the Investigator's judgment - Unresectable metastases |
Country | Name | City | State |
---|---|---|---|
Poland | The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw | Warsaw | Mazovian |
Lead Sponsor | Collaborator |
---|---|
Maria Sklodowska-Curie Institute - Oncology Center |
Poland,
Borghede G, Hedelin H. Radiotherapy of localised prostate cancer. Analysis of late treatment complications. A prospective study. Radiother Oncol. 1997 May;43(2):139-46. — View Citation
de Jong MA, Oldenborg S, Bing Oei S, Griesdoorn V, Kolff MW, Koning CC, van Tienhoven G. Reirradiation and hyperthermia for radiation-associated sarcoma. Cancer. 2012 Jan 1;118(1):180-7. doi: 10.1002/cncr.26252. Epub 2011 Jun 28. — View Citation
Haas RL, Miah AB, LePechoux C, DeLaney TF, Baldini EH, Alektiar K, O'Sullivan B. Preoperative radiotherapy for extremity soft tissue sarcoma; past, present and future perspectives on dose fractionation regimens and combined modality strategies. Radiother Oncol. 2016 Apr;119(1):14-21. doi: 10.1016/j.radonc.2015.12.002. Epub 2015 Dec 21. Review. — View Citation
Kosela-Paterczyk H, Szacht M, Morysinski T, Lugowska I, Dziewirski W, Falkowski S, Zdzienicki M, Pienkowski A, Szamotulska K, Switaj T, Rutkowski P. Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas. Eur J Surg Oncol. 2014 Dec;40(12):1641-7. doi: 10.1016/j.ejso.2014.05.016. Epub 2014 Sep 20. — View Citation
Lindner LH, Issels RD. Hyperthermia in soft tissue sarcoma. Curr Treat Options Oncol. 2011 Mar;12(1):12-20. doi: 10.1007/s11864-011-0144-6. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ratio of late adverse events | Ratio of grade 3 or higher late adverse events related to reirradiation, according to CTCAE 5.0 | 18 months | |
Secondary | Local control rate | 18 months | ||
Secondary | Progression-free survival | 18 months | ||
Secondary | Cancer-specific survival | 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04284774 -
Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial
|
Phase 2 | |
Active, not recruiting |
NCT03213678 -
Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
Active, not recruiting |
NCT03698994 -
Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
Active, not recruiting |
NCT03213665 -
Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
Recruiting |
NCT05560009 -
An Imaging Agent (Fluorodopa F 18) With Positron Emission Tomography/Magnetic Resonance Imaging for Assessing Treatment Response in Patients With High-Grade Soft Tissue Sarcomas
|
||
Active, not recruiting |
NCT04320888 -
Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial
|
Phase 2 | |
Active, not recruiting |
NCT02867592 -
Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
|
Phase 2 | |
Completed |
NCT03338959 -
Pembrolizumab and Radiation Therapy in Treating Patients With Intermediate or High-Grade Soft Tissue Sarcoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04901702 -
Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04619056 -
First-in-man Clinical Trial of CEB-01 PLGA Membrane in Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma
|
Phase 1 | |
Recruiting |
NCT03155620 -
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
|
Phase 2 | |
Active, not recruiting |
NCT04195555 -
Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
Active, not recruiting |
NCT03213704 -
Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
Active, not recruiting |
NCT03526250 -
Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
Recruiting |
NCT03213652 -
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
|
Phase 2 |