Study design and patient selection
neoplasms, skin cancer
NEOPLASMS, CERVICAL CANCER, SKIN CANCER, ONCOLOGY, MUCINOUS ADENOCARCINOMA
This trial is a prospective interventional single-centre phase 2 trial, registered with ClinicalTrials.gov identifier NCT04815694. The trial has received the ethics approval from the ethics committee of Fondazione Policlinico Universitario “A. Gemelli”, IRCCS of Rome, Italy (ethics committee identifier code 3460). Before participating in the trial, each patient has to provide written informed consent.All enrolled patients also undergo staging examinations including pelvic MRI, contrast-enhanced CT of the chest and abdomen or To be eligible for inclusion in the trial, patients must meet the following criteria: age > 18 years, Eastern Cooperative Oncology Group (ECOG) 0–1, adequate haematological function, LARC cT2-3, N0-2 or cT4 for anal sphincter involvement N0-2a, M0, located between 0 and 15 cm above the anal verge.
However, patients with high-risk features such as mesorectal fascial involvement, extra-mesorectal nodal involvement, extra-mesorectal venous invasion (EMVI) and rectal mucinous adenocarcinoma histology were excluded from the study. Other exclusion criteria include previous pelvic RT, history of previous neoplasms (except for skin cancer and early cervical cancer), pregnancy and/or lactation, prior chemotherapy (CHT), severe comorbidities, or any condition that may affect adherence to the study protocol and follow-up [Patients unable to undergo an MRI scan are excluded from the trial.