Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer

Kyungpook National University

Status and phase: Active, not recruiting; Phase 3

Conditions: Colon Cancer

Treatments: Drug: Conventional adjuvant FOLFOX; Drug: Neoadjuvant FOLFOX

Study type: Interventional

Funder types: Other

Identifiers

NCT03426904

KNUHCRC006

Details and patient eligibility

About

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.

Enrollment: 708 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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708 participants in 2 patient groups

Neoadjuvant FOLFOX

Experimental group

Description:

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

Treatment:

Drug: Neoadjuvant FOLFOX

Conventional adjuvant FOLFOX

Active Comparator group

Description:

surgery followed by 12 cycles of FOLFOX

Treatment:

Drug: Conventional adjuvant FOLFOX