# Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer

Source: https://onco.cc/trials/nct04495088/  
OnCo record `nct04495088` (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 fOLFOX (5-FU, leucovorin, oxaliplatin), cAPOX (capecitabine, oxaliplatin) and capecitabine in colorectal cancer, run by Ralf Hofheinz, now recruiting.

## Summary

Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT04495088 by Ralf Hofheinz, with a registry enrolment figure of 550 participants, started 2020-09-30 and due to reach its primary completion in 2030-08. Interventions recorded: mFOLFOX (neoadjuvant); XELOX (neoadjuvant); mFOLFOX (adjuvant); XELOX (adjuvant); Capecitabine (adjuvant); infusional 5-FU/FA "AIO" regimen (adjuvant); infusional 5-FU/FA "de Gramont" (adjuvant). Conditions listed: Rectal Cancer. Primary outcome: disease-free survival. Colorectal eligibility wording from the registry: "Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localised 0 - 16 cm from the anocutaneous line as measured by rigid rectoscopy (i". Sites: Germany. 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: NCT04495088
- Phase: 3
- Setting: Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer and Low Risk for Local Failure: A Randomized Phase III Trial of the German Rectal Cancer Study Group
- Sponsor: Ralf Hofheinz
- Enrolled: 550

## Sources

- ClinicalTrials.gov NCT04495088: https://clinicaltrials.gov/study/NCT04495088

## Connected records

- cancers: [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [CAPOX (capecitabine, oxaliplatin)](https://onco.cc/drugs/capox/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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JSON: https://onco.cc/api/v1/entities/nct04495088.json