{"entity":{"id":"nct02505750","kind":"trial","name":"Safety of a Boost (CXB or EBRT) in Combination With Neoadjuvant Chemoradiotherapy for Early Rectal Adenocarcinoma","aka":["OPERA"],"tldr":"A phase 3 trial of capecitabine in colorectal cancer, run by Centre Antoine Lacassagne, active but no longer recruiting.","summary":"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.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02505750","url":"https://clinicaltrials.gov/study/NCT02505750"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Royal Surrey County Hospital (Guildford); Spire Hull and East Riding Hospital (Hull); Clatterbridge Cancer Centre NHS Foundation Trust (Liverpool); Christie Hospital (Manchester); University Hospital (Nottingham)."],"nct":"NCT02505750","phase":"3","setting":"European Phase III Study Comparing a Radiation Dose Escalation Using 2 Different Approaches : External Beam Radiation Therapy Versus Endocavitary Radiation Therapy With Contact X-ray Brachytherapy 50 kiloVolts (kV) for Patients With Rectal Adenocarcinoma","sponsor":"Centre Antoine Lacassagne","enrolled":148,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct02505750/","neighbours":{"cancer":[{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}