Actively Recruiting
Phase III Study of Neoadjuvant FOLFOXIRI Chemotherapy Versus Immediate Surgery for High-risk Resectable Stage II and III Colon Cancers
Led by Sun Yat-sen University · Updated on 2022-01-18
840
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether giving chemotherapy before surgery with the FOLFOXIRI regimen improves disease-free survival compared to the standard approach of surgery followed by chemotherapy in patients with high-risk, resectable Stage II and III colon cancer. This study focuses on patients whose tumors show high-risk features on imaging and aims to see if treating the cancer before surgery can reduce tumor size and prevent cancer spread more effectively. Participants are randomly assigned to one of two groups. One group receives 12 weeks of FOLFOXIRI chemotherapy before surgery, followed by additional chemotherapy after surgery. The other group undergoes immediate surgery followed by 24 weeks of chemotherapy using FOLFOX, CAPOX, or capecitabine alone based on individual pathology and condition. If tumor progression is seen after three cycles of preoperative chemotherapy, surgery is performed sooner. The study is open-label and occurs across multiple centers. During the study, participants will undergo imaging and laboratory tests to monitor tumor response and safety. Researchers will assess disease-free survival over two years as the primary outcome. Secondary measures include overall survival over five years, tumor down-staging, chemotherapy side effects, surgical outcomes, and imaging assessments of tumor response. Participants are monitored closely during chemotherapy and surgery, with follow-up lasting up to five years to evaluate long-term outcomes.
CONDITIONS
Brief Title
Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma or high-grade dysplasia of the colon located at least 12 cm from the anal verge
- Preoperative imaging showing high-risk T3 tumor with more than 5 mm extension into mesenteric fat or T4 tumor penetrating visceral peritoneum or invading nearby organs
- pMMR or MSI-H status confirmed by immunohistochemistry or MSI testing
- Patients with acute colonic obstruction may participate after relief by a defunctioning stoma and recovery
- Adequate blood counts: white blood cells above 3.0 x10^9/L and platelets above 100 x10^9/L; anemia corrected before treatment
- Adequate kidney function with serum creatinine less than 1.5 times normal
- Adequate liver function with bilirubin and ALT less than 1.5 times normal
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- Patients advised to receive radiotherapy by the multidisciplinary team
- Evidence of distant metastases or peritoneal nodules (M1)
- dMMR status or MSI-L/MS-S in testing
- Peritonitis caused by tumor perforation
- Colonic obstruction not relieved by defunctioning stoma
- Serious medical conditions such as uncontrolled inflammatory bowel disease, uncontrolled angina, or recent myocardial infarction within 6 months
- Other serious illnesses compromising ability to tolerate treatment or surgery
- Any other cancer in the past 5 years except for certain low-risk skin or in situ cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants in the neoadjuvant chemotherapy arm receive mFOLFOXIRI chemotherapy every 14 days for up to 6 cycles before surgery.
6 chemotherapy visits every 2 weeks
Duration - 1 day
Participants undergo radical colectomy surgery following either neoadjuvant chemotherapy or immediately after screening if assigned to surgery-first arm.
1 surgical visit (in-person)
Duration - Up to 24 weeks depending on treatment plan
Participants receive postoperative chemotherapy with mFOLFOX6, CAPOX, or capecitabine based on surgical pathology and physical condition.
Chemotherapy visits every 2 or 3 weeks depending on regimen
Trial Site Locations
Total: 1 location
1
651 Dongfeng Road East
Guangzhou, Guangdong, China, 510060
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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