Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer
- Conditions
- Colon Cancer
- Interventions
- Drug: Conventional adjuvant FOLFOXDrug: Neoadjuvant FOLFOX
- Registration Number
- NCT03426904
- Lead Sponsor
- Kyungpook National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 708
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional adjuvant FOLFOX Conventional adjuvant FOLFOX surgery followed by 12 cycles of FOLFOX Neoadjuvant FOLFOX Neoadjuvant FOLFOX 4 cycles of FOLFOX (Folinic acid, fluorouracil and oxaliplatin) neoadjuvant followed by surgery and 8 cycles of FOLFOX
- Primary Outcome Measures
Name Time Method Relapse free survival after randomization 3 years after randomization
- Secondary Outcome Measures
Name Time Method Overall survival 3 year after randomization Quality of life (EORTC QLQ-C38) before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery Length of hospital stay 60 days after surgery Quality of life (EORTC QLQ-C30) before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery QLQ (quality of life questionnaire)
Radiological assessment of response to neoadjuvant treatment 6 months after surgery Incidence of completion of chemotherapy 1 year Accuracy of CT staging 1 year Pathological tumor stage 1 month after surgery Colon cancer stage by AJCC 8th edition
Pathological assessment of response to neoadjuvant treatment 1 months after surgery Replacement of the tumor by fibrous or fibro-inflammatory granulation tissue
Surgical complication 60 days after surgery Toxicity of chemotherapy 1 year Toxicity : incidence of chemotherapy-related adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) v4.0
Total cycles of perioperative chemotherapy 1 year
Trial Locations
- Locations (4)
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Chonnam, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
The Catholic Univ. of Korea St. Vincent's Hospital
🇰🇷Suwon-si, Korea, Republic of