Actively Recruiting
Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers
Led by Sun Yat-sen University · Updated on 2022-01-18
840
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
BACKGROUND: In patients with high risk stage II and stage III colon cancer (CC), curative surgery followed by adjuvant chemotherapy with FOLFOX or CAPOX regimens has become a standard treatment. However, 20 to 30 % of these patients will develop distant metastasis, which ultimately result in death. Perioperative chemotherapy is a promising strategy with potential benefits that could be more effective at eradicating micrometastases. Moreover, shrinking tumor before surgery not only facilitate removal of all the tumor by the surgeon but also reduce tumor cell spreading during the procedure. With recent advances in radiology, preoperative computed tomography allows a good prediction of tumor stage (wall penetration and nodal involvement) prior to surgery. The investigators conducted the present randomized study to explore whether perioperative chemotherapy with FOLFOXIRI regimen compared with postoperative chemotherapy could improve disease-free survival in patients with radiologically staged, High-risk, but resectable Stage II or III colon cancer. OBJECTIVE: The primary objective of this study is to evaluate the efficacy of perioperative chemotherapy with FOLFOXIRI regimen compared to postoperative chemotherapy in patients with High-risk Resectable Stage II and III colon cancer. Secondary objectives are efficacy in terms of R0 resection rate, overall survival (OS), relapse-free survival (RFS), down-staging of primary tumors, and tolerability of perioperative therapy and postoperative complications.
CONDITIONS
Official 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 invasive adenocarcinoma or high-grade dysplasia of the colon at least 12 cm from the anal verge
- Tumor stage determined by CT as high-risk T3 (tumor extends more than 5 mm into adjacent mesenteric fat) or T4 (tumor penetrates visceral peritoneum or invades adjacent organs)
- pMMR or MSI-H status confirmed by immunohistochemistry or MSI testing
- Patients with acute colonic obstruction eligible only after relief by defunctioning stoma and recovery to required fitness level
- 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 recommended for radiotherapy by the multidisciplinary team
- Evidence of distant metastases or peritoneal nodules (M1 disease)
- dMMR or MSI-L/MS-S status by immunohistochemistry or MSI testing
- Peritonitis caused by a perforated tumor
- Colonic obstruction not relieved by defunctioning stoma
- Serious medical conditions such as uncontrolled inflammatory bowel disease, unstable angina, or recent heart attack within 6 months
- Other serious medical conditions compromising ability to tolerate chemotherapy or surgery
- Any other cancer within the past 5 years except certain low-risk or early-stage cancers
AI-Screening
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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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