Not Yet RecruitingPhase 3

Pre-Operative Treatment in REseCTable COlon CanceR

Germany714 participantsStarted 2025-04

Plain-language summary

This is an open-label, randomized, controlled, multicenter, phase III study with two parallel arms. Patients with advanced colon cancer, including the upper third of the rectum, clinically staged cT3-4 and or cN+ (defined as lymph nodes with short axis of at least 1cm) are randomized in a 2:1 fashion (favoring preoperative therapy= Arm A) to investigate the efficacy, patient reported quality of life and safety of preoperative mFOLFOXIRI or mFOLFOX-6 or CAPOX followed by surgery versus the standard of care algorithm (surgery followed by stage-guided adjuvant therapy as recommended by the local multidisciplinary tumor board (Arm B)).

Who can participate

Age range18 Years – 120 Years

SexALL

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Inclusion criteria

✓. Patient's signed informed consent.
✓. Patient's age ≥18 years at the time of signing the informed consent.
✓. Histologically confirmed adenocarcinoma of the colon or upper rectum.
✓. Confirmed mismatch-repair proficient and/or microsatellite stable tumor. Both Immunohistochemistry and PCR can be used for diagnosis.
✓. Intent for curative surgery
✓. Predicted T3 or T4 stage and or nodal positivity (N+) in a computed tomography and/or magnetic resonance imaging scan of the abdomen/pelvis as assessed by the local study team.
✓. Absence of clear distant metastases assessed by the investigator based on respective routine evaluations within 6 weeks prior to inclusion into the trial (preferred: computed tomography of thorax and abdomen. Alternatively magnetic resonance images, sonography and x-rays might be used for assessment).
✓. Absence of significant active wound healing including severe chronic non-healing wounds, ulcerous lesions or untreated bone fracture

Exclusion criteria

What they're measuring

Disease-free survival (DFS)

Timeframe: LPI + 36 months (96 months total)

Trial details

NCT IDNCT06899477

SponsorDominik Paul Modest

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2033-04

Contact for this trial

Dominik Modest, Prof. Dr. med.

+49 30 450 dominik.modest@charite.de

View on ClinicalTrials.gov More Colo-rectal Cancer trials