Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer
NCT03426904 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 708
Last updated 2026-02-11
Summary
The main cause of recurrence after surgical treatment of colon cancer is distant metastasis. Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. Preoperative chemotherapy may eradicate microscopic metastatic cancer cells earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen the invasiveness of surgical resection. This randomized multicenter phase III trial is assessing whether preoperative chemotherapy improves oncologic outcomes of patients with locally advanced colon cancer.
Conditions
Interventions
- DRUG
-
Neoadjuvant FOLFOX
4 cycles of FOLFOX neoadjuvant chemotherapy and 8 cycles of postoperative chemotherapy
- DRUG
-
Conventional adjuvant FOLFOX
12 cycles of postoperative FOLFOX chemotherapy
Sponsors & Collaborators
-
Kyungpook National University Hospital
lead OTHER
Principal Investigators
-
Soo Yeun Park, MD · Kyungpook National University Chilgok Hospital
-
Gyu-Seog Choi, MD, PhD · Kyungpook National University Chilgok Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-23
- Primary Completion
- 2028-12-28
- Completion
- 2031-12-28
Countries
- South Korea
Study Locations
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