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

Source: https://onco.cc/trials/nct02505750/  
OnCo record `nct02505750` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-24
- Also known as: OPERA
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: 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

## 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).

## Sources

- ClinicalTrials.gov NCT02505750: https://clinicaltrials.gov/study/NCT02505750

## Connected records

- cancers: [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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