# Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Co

Source: https://onco.cc/trials/nct03671252/  
OnCo record `nct03671252` (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 FOLFOXIRI and cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Sun Yat-sen University, now recruiting.

## Summary

Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation is a phase 3, randomised interventional study registered as NCT03671252 by Sun Yat-sen University, with a registry enrolment figure of 776 participants, started 2018-11-16 and due to reach its primary completion in 2025-09-25. Interventions recorded: FOLFOXIRI; XELOX; Chemoradiotherapy; TME operation; efficacy evaluation. Conditions listed: Rectal Cancer. Primary outcome: 3-year disease free survival rate. Colorectal eligibility wording from the registry: "* 2）Histological diagnosis of rectal adenocarcinoma;". Sites: China. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT03671252
- Phase: 3
- Setting: Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation
- Sponsor: Sun Yat-sen University
- Enrolled: 776

## Sources

- ClinicalTrials.gov NCT03671252: https://clinicaltrials.gov/study/NCT03671252

## 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/), [Platinum agents](https://onco.cc/technologies/platinum/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- drugs: [CAPOX (capecitabine, oxaliplatin)](https://onco.cc/drugs/capox/), [FOLFOXIRI (5-FU, leucovorin, oxaliplatin, irinotecan)](https://onco.cc/drugs/folfoxiri/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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