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

This is a multicenter, prospective, randomized, stratified, controlled, open-label study comparing preoperative FOLFOX versus postoperative risk-adapted chemotherapy in patients with locally advanced rectal cancer and low risk for local failure

Trial Details

NCT ID

NCT04495088

Phase

PHASE3

Sponsor

Ralf Hofheinz

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

mFOLFOX (neoadjuvant)
XELOX (neoadjuvant)
mFOLFOX (adjuvant)
XELOX (adjuvant)
Capecitabine (adjuvant)
infusional 5-FU/FA "AIO" regimen (adjuvant)

Locations (sample)

Mannheim, Germany|49.4891,8.46694

Key Eligibility Criteria

Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localised 0 - 16 cm from the anocutaneous line as measure…
Staging requirements: High-resolution magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
Transrectal endoscopic ultrasound (EUS) is used to help discriminate between T1/2 and early T3 tumors.
MRI-defined inclusion criteria:

For full eligibility, visit ClinicalTrials.gov.

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