Status:
UNKNOWN
mFOLFOXIRI Versus mFOLFOX6 as Adjuvant Chemotherapy for Locally Advanced Colorectal Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The current standard treatment for locally advanced rectal cancer is still fluorouracil-based neoadjuvant radiotherapy and chemotherapy followed by TME surgery, followed by adjuvant chemotherapy. Fluo...
Detailed Description
This trial is a two-arm, multicenter, open labelled, prospective, randomized phase III studies. Eligible patients with locally advnaced colorectal cancer receiving oxlipaltin-based (less than 3 months...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
638 Patients enrolled
Trial Details
Trial ID
NCT04338191
Start Date
April 1 2020
End Date
February 1 2025
Last Update
December 27 2023
Active Locations (1)
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1
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655