Comparing two chemotherapy regimens for advanced colorectal cancer after surgery
mFOLFOXIRI Versus mFOLFOX6 as Adjuvant Chemotherapy for Locally Advanced Colorectal Cancer Patients After Preoperative Treatment With Oxaliplatin (FANTASTIC): a Multicenter, Phase 3 Randomized Controlled Trial
This study is testing two different chemotherapy treatments to see which one helps people with advanced colorectal cancer who have just had surgery stay cancer-free longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 638 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04338191 on ClinicalTrials.gov |
What this trial studies
This phase III trial aims to evaluate the effectiveness of mFOLFOXIRI versus mFOLFOX6 as adjuvant chemotherapy in patients with locally advanced colorectal cancer who have undergone curative surgery. Eligible participants, aged 18-70 years, will be randomly assigned to receive one of the two chemotherapy regimens for three months following their surgery. The study focuses on high-risk patients who have received oxaliplatin-based neoadjuvant treatment and are at risk of disease recurrence. The goal is to improve disease-free survival rates in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with locally advanced colorectal cancer who have undergone curative surgery and received prior oxaliplatin-based neoadjuvant treatment.
Not a fit: Patients with distant metastasis, significant cardiovascular disease, or those with other concurrent cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival outcomes for patients with high-risk locally advanced colorectal cancer.
How similar studies have performed: Other studies have shown promising results with similar chemotherapy regimens, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Gastrointestinal Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Yanhong Deng, Ph.D — Sixth Affiliated Hospital, Sun Yat-sen University
- Study coordinator: Yanhong Deng, Ph.D.
- Email: 13925106525@163.com
- Phone: 008613925106525
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.