Academic Journal
A phase 1 trial of the safety, tolerability and biological effects of intravenous Enadenotucirev, a novel oncolytic virus, in combination with chemoradiotherapy in locally advanced rectal cancer (CEDAR)
| Τίτλος: | A phase 1 trial of the safety, tolerability and biological effects of intravenous Enadenotucirev, a novel oncolytic virus, in combination with chemoradiotherapy in locally advanced rectal cancer (CEDAR) |
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| Συγγραφείς: | Séan M. O’Cathail, Steven Davis, Jane Holmes, Richard Brown, Kerry Fisher, Leonard Seymour, Richard Adams, James Good, David Sebag-Montefiore, Tim Maughan, Maria A. Hawkins |
| Πηγή: | Radiation Oncology, Vol 15, Iss 1, Pp 1-8 (2020) |
| Στοιχεία εκδότη: | BMC, 2020. |
| Έτος έκδοσης: | 2020 |
| Συλλογή: | LCC:Medical physics. Medical radiology. Nuclear medicine LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens |
| Θεματικοί όροι: | Radiation, Phase I, Rectal, Cancer, Oncolytic virus, Immuno-oncology, Medical physics. Medical radiology. Nuclear medicine, R895-920, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282 |
| Περιγραφή: | Abstract Background Chemoradiotherapy remains the standard of care for locally advanced rectal cancer. Efforts to intensify treatment and increase response rates have yet to yield practice changing results due to increased toxicity and/or absence of increased radiosensitization. Enadenotucirev (EnAd) is a tumour selective, oncolytic adenovirus which can be given intravenously. Pre-clinical evidence of synergy with radiation warrants further clinical testing and assessment of safety with radiation. Methods Eligibility include histology confirmed locally advanced rectal cancer that require chemoradiation. The trial will use a Time-to-Event Continual Reassessment Model-based (TiTE-CRM) approach using toxicity and efficacy as co-primary endpoints to recommend the optimal dose and treatment schedule 30 patients will be recruited. Secondary endpoints include pathological complete response the neoadjuvant rectal score. A translational program will be based on a mandatory biopsy during the second week of treatment for ‘proof-of-concept’ and exploration of mechanism. The trial opened to recruitment in July 2019, at an expected rate of 1 per month for up to 4 years. Discussion Chemoradiation with Enadenotucirev as a radiosensitiser in locally Advanced Rectal cancer (CEDAR) is a prospective multicentre study testing a new paradigm in radiosensitization in rectal cancer. The unique ability of EnAd to selectively infect tumour cells following intravenous delivery is an exciting opportunity with a clear translational goal. The novel statistical design will make efficient use of both toxicity and efficacy data to inform subsequent studies. Trial registration ClinicalTrial.gov, NCT03916510 . Registered 16th April 2019. |
| Τύπος εγγράφου: | article |
| Περιγραφή αρχείου: | electronic resource |
| Γλώσσα: | English |
| ISSN: | 1748-717X |
| Relation: | http://link.springer.com/article/10.1186/s13014-020-01593-5; https://doaj.org/toc/1748-717X |
| DOI: | 10.1186/s13014-020-01593-5 |
| Σύνδεσμος πρόσβασης: | https://doaj.org/article/7ce2e9a046514028ab5f12e3e58832fd |
| Αριθμός Καταχώρησης: | edsdoj.7ce2e9a046514028ab5f12e3e58832fd |
| Βάση Δεδομένων: | Directory of Open Access Journals |
| ISSN: | 1748717X |
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| DOI: | 10.1186/s13014-020-01593-5 |