Safety of a Boost (CXB or EBRT) in Combination With Neoadjuvant Chemoradiotherapy for Early Rectal Adenocarcinoma

Safety of a Boost (CXB or EBRT) in Combination With Neoadjuvant Chemoradiotherapy for Early Rectal Adenocarcinoma is a phase 3, randomised interventional study registered as NCT02505750 by Centre Antoine Lacassagne, with a registry enrolment figure of 148 participants, started 2015-06-24 and due to reach its primary completion in 2023-06-07. Interventions recorded: 3D conformal EBRT; Contact X-ray brachytherapy 50 kV; Capecitabine. Conditions listed: Rectal Neoplasms. Primary outcome: Rate of rectum preservation either with local excision or watch and wait strategy after neoadjuvant treatment without non salvageable locally progressive disease at 3 years post treatment, or permanent stoma.. Colorectal eligibility wording from the registry: "Adenocarcinoma of the rectum classified clinically T2, T3a, T3b (penetration in the mesorectal fat between 1 to 5 mm) by TNM classification (Tumour Node Metastase), \< 5 cm largest diameter, \< half rectal circumference (by MRI staging), N0-N1 (any node \< 8 mm diameter on MRI), M0". Sites: France, Switzerland, United Kingdom. United Kingdom sites listed: 5. No results are recorded here; the registry entry is the source.