Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer

NCT03426904 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: KNUHCRC006
• Study Type: interventional
• Target: 708
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Relapse free survival after randomization

  3 years after randomization

Secondary Outcomes (12)

• Overall survival

  3 year after randomization

• Radiological assessment of response to neoadjuvant treatment

  6 months after surgery

• Pathological assessment of response to neoadjuvant treatment

  1 months after surgery

• Surgical complication

  60 days after surgery

• Length of hospital stay

  60 days after surgery

Study Arms (2)

Neoadjuvant FOLFOX

EXPERIMENTAL

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

Drug: Neoadjuvant FOLFOX

Conventional adjuvant FOLFOX

ACTIVE COMPARATOR

surgery followed by 12 cycles of FOLFOX

Drug: Conventional adjuvant FOLFOX

Interventions

Neoadjuvant FOLFOX DRUG

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

Neoadjuvant FOLFOX

Conventional adjuvant FOLFOX DRUG

12 cycles of postoperative FOLFOX chemotherapy

Conventional adjuvant FOLFOX

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

Study Sites (4)

Chonnam National University Hwasun Hospital

Hwasun, Chonnam, 58128, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

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

Suwon, South Korea

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Soo Yeun Park, MD

  Kyungpook National University Chilgok Hospital

  STUDY DIRECTOR

• Gyu-Seog Choi, MD, PhD

  Kyungpook National University Chilgok Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kyungpook National University Hospital

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 8, 2018
• Study Start: October 23, 2020
• Primary Completion (Estimated): December 28, 2028
• Study Completion (Estimated): December 28, 2031
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)