Clinical trial NCT03426904: Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer
Official title: Neoadjuvant Chemotherapy for Non-metastatic Locally Advanced Colon Cancer: A Prospective Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Colon Cancer
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 708
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Relapse free survival after randomization
timeFrame: 3 years after randomization
Secondary outcomes:
measure: Overall survival
timeFrame: 3 year after randomization
measure: Radiological assessment of response to neoadjuvant treatment
timeFrame: 6 months after surgery
measure: Pathological assessment of response to neoadjuvant treatment
timeFrame: 1 months after surgery
measure: Surgical complication
timeFrame: 60 days after surgery
measure: Length of hospital stay
timeFrame: 60 days after surgery
measure: Quality of life (EORTC QLQ-C30)
timeFrame: before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery
measure: Quality of life (EORTC QLQ-C38)
timeFrame: before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery
measure: Toxicity of chemotherapy
timeFrame: 1 year
measure: Incidence of completion of chemotherapy
timeFrame: 1 year
measure: Accuracy of CT staging
timeFrame: 1 year
measure: Total cycles of perioperative chemotherapy
timeFrame: 1 year
measure: Pathological tumor stage
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Chonnam
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Suwon-si
country: Korea, Republic of
facility: The Catholic Univ. of Korea St. Vincent's Hospital
Study officials:
affiliation: Kyungpook National University Chilgok Hospital
name: Soo Yeun Park, MD
role: STUDY_DIRECTOR
affiliation: Kyungpook National University Chilgok Hospital
name: Gyu-Seog Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: