mFOLFOXIRI Versus mFOLFOX6 as Adjuvant Chemotherapy for Locally Advanced Colorectal Cancer

Launched by SUN YAT-SEN UNIVERSITY · Apr 7, 2020

Keywords

ClinConnect Summary

This clinical trial is studying two different chemotherapy treatments, mFOLFOXIRI and mFOLFOX6, to see which one is more effective for patients with locally advanced colorectal cancer after they have had surgery. The goal is to improve the chances of survival for patients who are at high risk of their cancer returning after surgery. The trial is currently looking for participants aged 18 to 70 who have recently received oxaliplatin as part of their preoperative treatment and have undergone successful surgery for their cancer.

If you join the trial, you will be randomly assigned to receive either mFOLFOXIRI or mFOLFOX6 for your treatment. Both of these regimens include a combination of chemotherapy drugs, but mFOLFOXIRI uses an additional drug that may help improve treatment outcomes. You will be monitored throughout the study to see how well the treatment works and to check for any side effects. It’s important to know that this trial is focused on helping patients who have a higher risk of their cancer coming back, so your participation could contribute to better treatment options for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-70 years
• • ECOG PS 0-1
• • Exposure to Oxaliplatin in preoperative treatment (less than 3 months)
• • Induction or consolidation chemotherapy in rectal cancer or Concurrent FOLFOX with CRT in rectal cancer
• • Neoadjuvant treatment with CAPOX or FOLFOX in colon cancer
• • Curative surgery (R0 resection)
• • ypStage IIB, IIC and ypStage III
• • No distant metastasis after surgery
• • ≤ 8 weeks prior to randomization
• Exclusion Criteria:
• • Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
• • Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
• • Heart failure grade III/IV (NYHA-classification).
• • Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.
• • Subjects with known allergy to the study drugs or to any of its excipients.
• • Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
• • Breast- feeding or pregnant women
• • Lack of effective contraception