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

> **NCT04495088** · PHASE3 · RECRUITING · sponsor: **Ralf Hofheinz** · enrollment: 550 (estimated)

## Conditions studied

- Rectal Cancer

## Interventions

- **DRUG:** mFOLFOX (neoadjuvant)
- **DRUG:** XELOX (neoadjuvant)
- **DRUG:** mFOLFOX (adjuvant)
- **DRUG:** XELOX (adjuvant)
- **DRUG:** Capecitabine (adjuvant)
- **DRUG:** infusional 5-FU/FA "AIO" regimen (adjuvant)
- **DRUG:** infusional 5-FU/FA "de Gramont" (adjuvant)

## Key facts

- **NCT ID:** NCT04495088
- **Lead sponsor:** Ralf Hofheinz
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2020-09-30
- **Primary completion:** 2030-08
- **Final completion:** 2030-08
- **Target enrollment:** 550 (ESTIMATED)
- **Last updated:** 2026-02-02

## Collaborators

- [object Object]
- [object Object]
- [object Object]

## Primary source

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

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04495088, "Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT04495088. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
