Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer

NCT ID: NCT03426904

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 708 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-24
• Study Completion Date: 2030-12-28

Brief 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

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant FOLFOX

4 cycles of FOLFOX (Folinic acid, fluorouracil and oxaliplatin) neoadjuvant followed by surgery and 8 cycles of FOLFOX

Group Type: EXPERIMENTAL

Neoadjuvant FOLFOX

Intervention Type: DRUG

4 cycles of FOLFOX neoadjuvant chemotherapy and 8 cycles of postoperative chemotherapy

Conventional adjuvant FOLFOX

surgery followed by 12 cycles of FOLFOX

Group Type: ACTIVE_COMPARATOR

Conventional adjuvant FOLFOX

Intervention Type: DRUG

12 cycles of postoperative FOLFOX chemotherapy

Interventions

Neoadjuvant FOLFOX

4 cycles of FOLFOX neoadjuvant chemotherapy and 8 cycles of postoperative chemotherapy

Intervention Type: DRUG

Conventional adjuvant FOLFOX

12 cycles of postoperative FOLFOX chemotherapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pathologically confirmed colon adenocarcinoma (> 15 cm from the anal verge)
• Radiologic T3/T4 and high risk features by CT scan
• No metastasis on CT or PET(positron emission computed tomography)
• Age ≥ 18 and ≤ 70 years
• ECOG (Eastern Cooperative Oncology Group) performance status 0-1
• No history of colorectal cancer within 5 years
• No history of chemotherapy
• Patients with childbearing potential should use effective contraception during the study and the following 6 months
• Adequate bone marrow function : white blood cell count of 2 x 109/L or more with neutrophils of1.5 x 109/L or more, platelet count of 100 x 109/L or more, hemoglobin of 9 g/dL (5,6 mmol/l) or more
• Adequate hepatobiliary function : total bilirubin of 0.4 mg/dl or less, ASAT (aspartate aminotransferase) and ALAT (alanine aminotransferase) of 2.5 x ULN (upper limits of normal) or less, Alkaline phosphatase of 1.5 x ULN or less
• Adequate renal function : GFR (Glomerular Filtration Rate) > 50ml/min by Wright or Cockcroft formula
• Signed written informed consent obtained prior to any study specific screening procedures

Exclusion Criteria

• Age > 70 years and < 18 years
• Rectal cancer : 15 cm or less from the anal verge
• Complicated colon cancer (complete obstruction, perforation, bleeding)
• Metastatic colon cancer
• Known hypersensitivity reaction to any of the components of study treatments
• Inflammatory bowel disease
• Hereditary nonpolyposis colorectal cancerHNPCC, familial Adenomatous Polyposis
• Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, high risk of uncontrolled arrhythmia
• Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Pregnancy or breast-feeding period
• Serious non-healing wound or bone fracture
• Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
• Any significant disease which, in the investigator's opinion, would exclude the patient from the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyungpook National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gyu-Seog Choi

Kyungpook National University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soo Yeun Park, MD

Role: STUDY_DIRECTOR

Kyungpook National University Chilgok Hospital

Gyu-Seog Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Chilgok Hospital

Locations

Chonnam National University Hwasun Hospital

Hwasun, Chonnam, South Korea

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Asan Medical Center

Seoul, , South Korea

The Catholic Univ. of Korea St. Vincent's Hospital

Suwon, , South Korea

Countries

South Korea

Other Identifiers

KNUHCRC006

Identifier Type: -

Identifier Source: org_study_id