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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
mFOLFOXIRI
DrugUp 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
DrugUp 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
DrugUp 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
Treatment groups
714 Participants
are divided into 2 treatment groupsGroup A: Arm A: Pre-operative treatmentExperimental treatment 3 interventions
Group B: Arm B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Disease-free survival (DFS)
Disease-free survival (DFS) - defined as no surgery, no resection, incomplete resection, disease recurrence (new metastases or local relapse) and death from any cause from the time of randomization. In case of no surgery ,no resection, or incomplete resection (defined as R2 resection = macroscopic tumor rest), the timepoint of the respective event will be set to two weeks after randomization to avoid time-bias in favor of the experimental/neoadjuvant therapy arm.
Time frame
LPI + 36 months (96 months total)Secondary outcomes
1
Overall survival (OS)
time from randomization to the date of death of any cause
Time frame
LPI + 60 months (120 months total)2
Tumor regression grades (TRS)
according to Dworak's score
Time frame
LPI + 60 months (120 months total)3
(Serious) Adverse Events
Type, incidence, severity, and causal relationship to active chemotherapy of non-serious adverse events and serious adverse events (severity evaluated according to CTCAE version 5.0), rate of surgery complication scores (Clavien Dindo)
Time frame
LPI + 60 months (120 months total)4
Quality of life (QoL)
assessed with the QoL questionnaire EQ-5D-5L
Time frame
LPI + 60 months (120 months total)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dominik Paul Modest
Lead sponsor
Charite University, Berlin, Germany
Sponsor institution
Frankfurter Institut für Klinische Krebsforschung IKF GmbH
Collaborator
Source ClinicalTrials.gov
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