A prospective study investigating the efficacy and toxicity of definitive ChemoRadiation and ImmunOtherapy (CRIO) in locally and/or regionally advanced unresectable cutaneous squamous cell carcinoma
| العنوان: | A prospective study investigating the efficacy and toxicity of definitive ChemoRadiation and ImmunOtherapy (CRIO) in locally and/or regionally advanced unresectable cutaneous squamous cell carcinoma |
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| المؤلفون: | Paul Thomas, Michelle K. Nottage, Jacqui Keller, Trang Le, Trishna Ballah, Karen Hay, Benjamin Chua, Charles P. Lin, Lizbeth Kenny, Brett G.M. Hughes, Jennifer Edmunds, Michele Teng |
| المصدر: | Radiation Oncology, Vol 16, Iss 1, Pp 1-13 (2021) Radiation Oncology (London, England) |
| بيانات النشر: | BMC, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Oncology, Curative, lcsh:Medical physics. Medical radiology. Nuclear medicine, medicine.medical_specialty, Receptors, CXCR4, Durvalumab, Skin Neoplasms, medicine.medical_treatment, lcsh:R895-920, lcsh:RC254-282, 03 medical and health sciences, Study Protocol, 0302 clinical medicine, Internal medicine, Positron Emission Tomography Computed Tomography, medicine, Humans, Skin cancer, Radiology, Nuclear Medicine and imaging, Progression-free survival, Prospective Studies, Stage (cooking), Neoplasm Metastasis, Prospective cohort study, 030304 developmental biology, 0303 health sciences, Radiotherapy, business.industry, Standard treatment, Australia, Antibodies, Monoclonal, Chemoradiotherapy, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Combined Modality Therapy, Progression-Free Survival, SCC, Radiation therapy, Clinical trial, Treatment Outcome, 030220 oncology & carcinogenesis, Lymphatic Metastasis, Carcinoma, Squamous Cell, Immunotherapy, business |
| الوصف: | Background Patients with unresectable advanced cutaneous squamous cell carcinoma (cSCC) are generally treated with palliative intent. Immune checkpoint blockade has significant activity in the palliative setting in patients with recurrent or metastatic cSCC. This single arm phase 2 prospective study aims to investigate the combination of curative intent chemoradiation and durvalumab (anti-PD-L1 checkpoint inhibitor) for this patient cohort. Methods Patients with unresectable locally and or regionally advanced pathologically confirmed cSCC (stage III-IVa) deemed fit for CRIO by consensus of the Multidisciplinary meeting will be eligible. In the first stage of a two-stage minimax design, we aim to recruit a total of 15 patients. If fewer than 7 patients achieved a complete response in the first stage, we will conclude the treatment is not more effective than standard treatment. The co-primary endpoints of CRIO are the safety of treatment (acute and late toxicities) and the rate of complete response. Secondary endpoints would include overall survival, progression free survival, and locoregional control. Translational research endpoints including biomarkers (CD73, CD39, PD-1, PD-L1) will also be explored utilising multiplex immunohistochemistry on tumour biopsy samples obtained prior to commencing treatment and during treatment (week 2). In addition, the utility of CXCR-4 PET/CT scan will be explored. Discussion CRIO is a novel trial evaluating the combination of curative intent chemoradiotherapy with concurrent and adjuvant durvalumab for patients with unresectable stage III-IVa cSCC. Trial registration: Trial registered with the Australian New Zealand Clinical Trial Registry (ACTRN12618001573246) |
| اللغة: | English |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::81a0de0e53a95dc311ca6ebc241ee8d5 https://doaj.org/article/724133bc3d914f09a780fd4e48db3a69 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....81a0de0e53a95dc311ca6ebc241ee8d5 |
| قاعدة البيانات: | OpenAIRE |
| الوصف غير متاح. |