RADIANCE – Radiochemotherapy with or without Durvalumab in the treatment of anal squamous cell carcinoma: A randomized multicenter phase II trial

Autor: Daniel Martin, Panagiotis Balermpas, Johannes Gollrad, Christian Weiß, Chiara Valentini, Martin Stuschke, Henning Schäfer, Christoph Henkenberens, Jürgen Debus, David Krug, Thomas Kuhnt, Thomas Brunner, Tilman Bostel, Rita Engenhart-Cabillic, Ursula Nestle, Stephanie E. Combs, Claus Belka, Matthias Hautmann, Guido Hildebrandt, Cihan Gani, Bülent Polat, Claus Rödel, Emmanouil Fokas
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Clinical and Translational Radiation Oncology, Vol 23, Iss , Pp 43-49 (2020)
Druh dokumentu: article
ISSN: 2405-6308
DOI: 10.1016/j.ctro.2020.04.010
Popis: Purpose: Anal squamous cell carcinomas (ASCC) are increasing in frequency across the developed world. The 3-year disease-free survival (DFS) in patients with locally-advanced disease is approximately 60% after primary radiochemotherapy (RCT). There is a strong rationale for combining immunotherapy with RCT in patients with ASCC due to its association with human papilloma virus (HPV) infection. Methods/design: RADIANCE is an investigator initiated, prospective, multicenter, randomized phase II trial testing the addition of Durvalumab, a PD-L1 immune checkpoint inhibitor, to standard RCT in 178 patients with locally advanced ASCC (T2 ≥ 4 cm Nany, cT3-4 and/or cN+). In the control arm, patients will be treated with standard mitomycin C (MMC)/5-fluorouracil (5-FU)-based RCT. Intensity-modulated radiotherapy (IMRT) will be applied as follows: PTV_A (primary tumor) T1-T2
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