Pre-Operative Treatment in REseCTable COlon CanceR
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-120
SponsorDominik Paul Modest
About this trial
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)).
Eligibility criteria
Qualifiers
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.
Disqualifiers
Ileus or directly imminent ileus as assessed by the local study team. Patients with treated and resolved ileus are allowed into the trial.
Previous chemotherapy for colorectal cancer of any stage
New York Heart Association Class III or greater heart failure by clinical judgement.
Myocardial infarction within 6 months prior to randomization; percutaneous transluminal coronary angioplasty (PTCA) with or without stenting within 6 months prior to randomization.
Trial design
Treatments tested in this trial
- mFOLFOXIRI
- mFOLFOX-6
- CAPOX
Treatment groups
714 Participants
are divided into 2 treatment groupsSponsors and collaborators
Dominik Paul Modest
Lead sponsor
Charite University, Berlin, Germany
Sponsor institution
Frankfurter Institut für Klinische Krebsforschung IKF GmbH
Collaborator
Source ClinicalTrials.gov