MORPHEUS Phase II-III Study: A Pre-Planned Interim Safety Analysis and Preliminary Results.

ABSTRACT:

Background

We explored image-guided adaptive endorectal brachytherapy patients electing non-operative management for rectal cancer. We present the first pre-planned interim analysis.

Methods

In this open-label phase II-III randomized study, patients with operable cT2-3ab N0 M0 rectal cancer received 45 Gy in 25 fractions of pelvic external beam radiotherapy (EBRT) with 5-FU/Capecitabine. They were randomized 1:1 to receive either an EBRT boost of 9 Gy in 5 fractions (Arm A) or three weekly adaptive brachytherapy (IGAEBT) boosts totaling 30 Gy (Arm B). Patient characteristics and toxicity are presented using descriptive analyses; TME-free survival between arms with the intention to treat the population is explored using the Kaplan-Meier method.

Results

A total of 40 pa

SUBMITTER: Garant A 

PROVIDER: S-EPMC9367346 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature