1. Updated protocol of the SANO trial
- Author
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on behalf of the SANO-study group, B.M. (Ben) Eyck, B.J. (Berend Jan) van der Wilk, B.J. (Bo) Noordman, B.P.L. (Bas) Wijnhoven, S.M. (Sjoerd) Lagarde, Henk H. Hartgrink, PPOL (Peter-Paul) Coene, Jan Willem T. Dekker, M. (Michail) Doukas, Ate van der Gaast, Joos Heisterkamp, Ewout A. Kouwenhoven, Grard A.P. Nieuwenhuijzen, Jean Pierre E.N. Pierie, Camiel Rosman, Johanna W. van Sandick, Maurice J.C. van der Sangen, Meindert N. Sosef, Edwin S. van der Zaag, V.M.C.W. (Manon) Spaander, Roelf Valkema, H.F. (Hester) Lingsma, E.W. (Ewout) Steyerberg, J.J.B. (Jan) van Lanschot, on behalf of the SANO-study group, B.M. (Ben) Eyck, B.J. (Berend Jan) van der Wilk, B.J. (Bo) Noordman, B.P.L. (Bas) Wijnhoven, S.M. (Sjoerd) Lagarde, Henk H. Hartgrink, PPOL (Peter-Paul) Coene, Jan Willem T. Dekker, M. (Michail) Doukas, Ate van der Gaast, Joos Heisterkamp, Ewout A. Kouwenhoven, Grard A.P. Nieuwenhuijzen, Jean Pierre E.N. Pierie, Camiel Rosman, Johanna W. van Sandick, Maurice J.C. van der Sangen, Meindert N. Sosef, Edwin S. van der Zaag, V.M.C.W. (Manon) Spaander, Roelf Valkema, H.F. (Hester) Lingsma, E.W. (Ewout) Steyerberg, and J.J.B. (Jan) van Lanschot
- Abstract
Background: The Surgery As Needed for Oesophageal cancer (SANO) trial compares active surveillance with standard oesophagectomy for patients with a clinically complete response (cCR) to neoadjuvant chemoradiotherapy. The last patient with a clinically complete response is expected to be included in May 2021. The purpose of this update is to present all amendments to the SANO trial protocol as approved by the Institutional Research Board (IRB) before accrual is completed. Design: The SANO trial protocol has been published (https://doi.org/10.1186/s12885-018-4034-1). In this ongoing, phase-III, non-inferiority, stepped-wedge, cluster randomised controlled trial, patients with cCR (i.e. after neoadjuvant chemoradiotherapy no evidence of residual disease in two consecutive clinical response evaluations [CREs]) undergo either active surveillance or standard oesophagectomy. In the active surveillance arm, CREs are repeated every 3 months in the first year, every 4 months in the second year, every 6 months in the third year, and yearly in the fourth and fifth year. In this arm, oesophagectomy is offered only to patients in whom locore
- Published
- 2021
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