Rationale and design of REGINA, a phase II trial of neoadjuvant regorafenib, nivolumab, and short-course radiotherapy in stage II and III rectal cancer

Bregni, Giacomo;Vandeputte, Caroline;Pretta, Andrea;Senti, Chiara;Sclafani, Francesco;et.al.
(2021) Acta Oncologica — Vol. 60, n° 4, p. 549-553 (2021)

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(en) INTRODUCTIION : Standard treatment for stage II and III rectal cancer has long consisted of neoadjuvant long-course chemoradiotherapy (CRT) or short-course radiotherapy (SCRT) followed by total mesorectal excision (TME) plus or minus adjuvant chemotherapy. Recently, results from the RAPIDO and PRODIGE-23 trials suggested superiority of the ‘total neoadjuvant therapy’ approach (i.e., systemic chemotherapy delivered before or after pre-operative (C)RT) over standard treatment in terms of pathological complete response (pCR), and disease-related treatment failure and disease-free survival, respectively [...].
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Bregni, G., Vandeputte, C., Pretta, A., Senti, C., Trevisi, E., Acedo Reina, E., Kehagias, P., Liberale, G., Moretti, L., Bali, M. A., Demetter, P., Flamen, P., Carrasco, J., D’Hondt, L., Geboes, K., Gokburun, Y., Peeters, M., Van den Eynde, M., Van Laethem, J.-L., et al. (2021). Rationale and design of REGINA, a phase II trial of neoadjuvant regorafenib, nivolumab, and short-course radiotherapy in stage II and III rectal cancer. Acta Oncologica, 60(4), 549-553. https://doi.org/10.1080/0284186X.2020.1871067 (Original work published 2021)