Pre-Operative Treatment in REseCTable COlon CanceR

Sponsor
Dominik Paul Modest
Study ID
NCT06899477
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • mFOLFOXIRI — DRUG
    Up to 6 cycles, every 2 weeks, mFOLFOXIRI: Oxaliplatin 85 mg/m2 2 h day 1, Irinotecan 150 mg/m2 60-90 min day 1, Folinic acid 400 mg/m2 \~1 h day 1, followed by 5-FU 2400 mg/m2 46 h
  • mFOLFOX-6 — DRUG
    Up to 6 cycles, every 2 weeks, mFOLFOX-6: Oxaliplatin 85 mg/m2 2 h day 1, Folinic acid 400 mg/m2 \~1 h day 1, (optional: 5-FU 400 mg/m2 bolus), followed by 5-FU 2400 mg/m2 46 h.
  • CAPOX — DRUG
    Up to 4 cycles, every 3 weeks, CAPOX: Oxaliplatin 130 mg/m2 3 h day 1, Capecitabine 1000 mg/m2 ORALLY taken twice daily d1-d14

Study Details

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)).

Key Dates

First listed
Mar 28, 2025
Start date
Apr 30, 2025
Status verified
Mar 2025
Primary completion
Apr 30, 2033
Completion
Apr 30, 2035

Study Design

Enrollment
714 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Pre-operative treatment
    Arm A: choice of one of the offered pre-operative regimens: 1. Up to 6 cycles, every 2 weeks, mFOLFOXIRI 2. Up to 6 cycles, every 2 weeks, mFOLFOX-6 3. Up to 4 cycles, every 3 weeks, CAPOX followed by structured Follow-up for up to 60months after randomization
  • No Intervention: Arm B: Control
    Structured follow-up for at least 60 months after randomization

Primary Outcome Measure

Disease-free survival (DFS) [ Time Frame: LPI + 36 months (96 months total) ]

Central Contacts

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