Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol
Introduction Up to 50% of soft tissue sarcoma (STS) patients develop metastases in the course of their disease. Cytotoxic therapy is a standard treatment in this setting but yields average tumour response rates of 25% at first line and ≤10% at later lines. In oligometastatic stage, stereotactic body...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e038391.full |
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| author | Nicolas Penel Dominique Vaur Juliette Thariat Alexandre Escande Jennifer le Guevelou Colin Debaigt Esma Saada-Bouzid Julien Viotti Nazim Khalladi David Thibouw Marie Pierre Sunyach Laurence Moureau-Zabotto Mohamed Benchalal Ovidiu Veresezan Anne Ducassou Cecile le Pechoux Maria Jolnerovski Celine Bazille Raphael Serre Christine Lovera |
| author_facet | Nicolas Penel Dominique Vaur Juliette Thariat Alexandre Escande Jennifer le Guevelou Colin Debaigt Esma Saada-Bouzid Julien Viotti Nazim Khalladi David Thibouw Marie Pierre Sunyach Laurence Moureau-Zabotto Mohamed Benchalal Ovidiu Veresezan Anne Ducassou Cecile le Pechoux Maria Jolnerovski Celine Bazille Raphael Serre Christine Lovera |
| author_sort | Nicolas Penel |
| collection | DOAJ |
| description | Introduction Up to 50% of soft tissue sarcoma (STS) patients develop metastases in the course of their disease. Cytotoxic therapy is a standard treatment in this setting but yields average tumour response rates of 25% at first line and ≤10% at later lines. In oligometastatic stage, stereotactic body radiation therapy (SBRT) allows reaching high control rates at treated sites (≥80%) and is potentially equally effective to surgery in term of overall survival. In order to shift the balance towards antitumour immunity by multisite irradiation, radiation could be combined with inhibitors of the immunosuppressive pathways.Methods and analysis STEREOSARC is a prospective, multicentric, randomised phase II, designed to evaluate the efficacy of SBRT associated with immunotherapy versus SBRT only. Randomisation is performed with a 2:1 ratio within two arms. The primary objective is to evaluate the efficacy, in term of progression-free survival (PFS) rate at 6 months, of immunomodulated stereotactic multisite irradiation in oligometastatic sarcoma patients. The secondary objectives include PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution. Patients will be randomised in two groups: SBRT with atezolizumab and SBRT alone. The total number of included patients should be 103.Trial registration The trial is registered on ClinicalTrials.gov (ID: NCT03548428).Ethics and dissemination This study has been approved by Comité de Protection des Personnes du sud-ouest et outre-mer 4 on 18 October 2019 (Reference CPP2019-09-076-PP) and from National Agency for Medical and Health products Safety (Reference: MEDAECNAT-2019-08-00004_2017-004239-35) on 18 September 2019.The results will be disseminated to patients upon individual request or through media release from scientific meetings. The results will be communicated through scientific meetings and publications. |
| format | Article |
| id | doaj-art-4f03745252c94dfdb17bc3efe4d08e20 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-4f03745252c94dfdb17bc3efe4d08e202025-01-08T18:50:08ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-038391Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocolNicolas Penel0Dominique Vaur1Juliette Thariat2Alexandre Escande3Jennifer le Guevelou4Colin Debaigt5Esma Saada-Bouzid6Julien Viotti7Nazim Khalladi8David Thibouw9Marie Pierre Sunyach10Laurence Moureau-Zabotto11Mohamed Benchalal12Ovidiu Veresezan13Anne Ducassou14Cecile le Pechoux15Maria Jolnerovski16Celine Bazille17Raphael Serre18Christine Lovera1911 Department of Medical Oncology, Centre Oscar Lambret and Lille University Hospital, Lille, France2 Laboratory of Clinical Biology and Oncology, Centre François Baclesse, Inserm U1245 Genomics and Personalized Medicine in Cancer and Neurological Disorders, Normandy University, Caen, FranceRadiation oncology department, Centre de Lutte Contre le Cancer, Centre Francois Baclesse, Caen, FranceRadiation oncology department, Oscar Lambret Cancer Centre, Lille, Hauts-de-France, FranceRadiation oncology department, Centre de Lutte Contre le Cancer, Centre Francois Baclesse, Caen, Franceclinical research department, UNICANCER, Paris, Île-de-France, FranceMedical oncology department, Centre Antoine Lacassagne, Nice, Provence-Alpes-Côte d`Azur, FranceMedical oncology department, Centre Antoine Lacassagne, Nice, Provence-Alpes-Côte d`Azur, FranceBiomolecular pathology department, Centre de Lutte Contre le Cancer, Centre François Baclesse, Caen, FranceMedical oncology department, Georges-Francois Leclerc Centre, Dijon, Bourgogne-Franche-Comté, FranceCentre Léon Bérard, Lyon, Rhône-Alpes, FrancePaoli-Calmettes Institute, Marseille, Provence-Alpes-Côte d`Azur, FranceEugène Marquis Cancer Institute, Rennes, Bretagne, FranceRadiation oncology department, CHU Rouen Biochimie Médicale, Rouen, Haute-Normandie, France4 Radiation Oncology and Brachytherapy Department, Institut Universitaire du Cancer de Toulouse - Oncopole, Institut Claudius Regaud, Toulouse, FranceRadiation oncology department, Gustave Roussy, Villejuif, Franceclinical research department, UNICANCER, Paris, Île-de-France, FranceBiomolecular pathology department, CHU Caen, Caen, Basse-Normandie, FranceRadiation oncology department, CHU Limoges, Limoges, Franceclinical research department, UNICANCER, Paris, Île-de-France, FranceIntroduction Up to 50% of soft tissue sarcoma (STS) patients develop metastases in the course of their disease. Cytotoxic therapy is a standard treatment in this setting but yields average tumour response rates of 25% at first line and ≤10% at later lines. In oligometastatic stage, stereotactic body radiation therapy (SBRT) allows reaching high control rates at treated sites (≥80%) and is potentially equally effective to surgery in term of overall survival. In order to shift the balance towards antitumour immunity by multisite irradiation, radiation could be combined with inhibitors of the immunosuppressive pathways.Methods and analysis STEREOSARC is a prospective, multicentric, randomised phase II, designed to evaluate the efficacy of SBRT associated with immunotherapy versus SBRT only. Randomisation is performed with a 2:1 ratio within two arms. The primary objective is to evaluate the efficacy, in term of progression-free survival (PFS) rate at 6 months, of immunomodulated stereotactic multisite irradiation in oligometastatic sarcoma patients. The secondary objectives include PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution. Patients will be randomised in two groups: SBRT with atezolizumab and SBRT alone. The total number of included patients should be 103.Trial registration The trial is registered on ClinicalTrials.gov (ID: NCT03548428).Ethics and dissemination This study has been approved by Comité de Protection des Personnes du sud-ouest et outre-mer 4 on 18 October 2019 (Reference CPP2019-09-076-PP) and from National Agency for Medical and Health products Safety (Reference: MEDAECNAT-2019-08-00004_2017-004239-35) on 18 September 2019.The results will be disseminated to patients upon individual request or through media release from scientific meetings. The results will be communicated through scientific meetings and publications.https://bmjopen.bmj.com/content/10/9/e038391.full |
| spellingShingle | Nicolas Penel Dominique Vaur Juliette Thariat Alexandre Escande Jennifer le Guevelou Colin Debaigt Esma Saada-Bouzid Julien Viotti Nazim Khalladi David Thibouw Marie Pierre Sunyach Laurence Moureau-Zabotto Mohamed Benchalal Ovidiu Veresezan Anne Ducassou Cecile le Pechoux Maria Jolnerovski Celine Bazille Raphael Serre Christine Lovera Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol BMJ Open |
| title | Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol |
| title_full | Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol |
| title_fullStr | Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol |
| title_full_unstemmed | Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol |
| title_short | Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol |
| title_sort | phase ii study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas stereosarc trial protocol |
| url | https://bmjopen.bmj.com/content/10/9/e038391.full |
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