Comparing two chemotherapy regimens for advanced colorectal cancer after surgery
mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or Stage IIIC Colorectal Cancer: A Randomized Controlled Clinical Research
This study is testing two different chemotherapy treatments to see which one helps people with advanced colorectal cancer after surgery feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Wenzhou Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Trial ID | NCT05200299 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of two different adjuvant chemotherapy regimens, mFOLFOXIRI and mFOLFOX6/CapeOx, in patients who have undergone surgery for stage IIIB or IIIC colorectal cancer. Postoperative patients will be randomly assigned to receive one of the two treatments for six months, with the option to switch regimens if they experience intolerable side effects. The study aims to evaluate disease-free survival, overall survival, and quality of life, as well as the incidence of adverse reactions associated with the chemotherapy. The trial is designed as a two-arm, open-label, prospective, randomized phase II study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have undergone curative surgery for stage IIIB or IIIC colorectal cancer without distant metastasis.
Not a fit: Patients with prior chemotherapy or radiotherapy, significant cardiovascular disease, or other concurrent cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective chemotherapy option for patients with advanced colorectal cancer, potentially improving survival rates and quality of life.
How similar studies have performed: While there have been studies comparing various chemotherapy regimens for colorectal cancer, the specific comparison of mFOLFOXIRI to mFOLFOX6/CapeOx in this postoperative setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75 years * ECOG PS 0-1 * Curative surgery (R0 resection) * ypStage III B and ypStage III C * No distant metastasis after surgery Exclusion Criteria: * any treatment before surgery including chemotherapy, radiotherapy and targeted agents. * 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
Where this trial is running
Wenzhou, Zhejiang
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Ye Lechi, M.D.
- Email: yljwenzhou@126.com
- Phone: 008613868803676
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.