Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer

Colon Cancer Clinical Trial

Official title:

Neoadjuvant Chemotherapy for Non-metastatic Locally Advanced Colon Cancer: A Prospective Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03426904
• Other study ID #: KNUHCRC006
• Status: Recruiting
• Phase: Phase 3
• Start date: October 24, 2018
• Est. completion date: December 28, 2029

Study information

• Verified date: March 2023
• Source: Kyungpook National University Hospital
• Contact: Soo Yeun Park, MD
• Phone: +82-53-200-2166
• Email: psy-flower[@]daumm.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: December 28, 2029
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Drug:
• Neoadjuvant FOLFOX
4 cycles of FOLFOX neoadjuvant chemotherapy and 8 cycles of postoperative chemotherapy
• Conventional adjuvant FOLFOX
12 cycles of postoperative FOLFOX chemotherapy

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Chonnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	The Catholic Univ. of Korea St. Vincent's Hospital	Suwon-si

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse free survival after randomization		3 years after randomization
Secondary	Overall survival		3 year after randomization
Secondary	Radiological assessment of response to neoadjuvant treatment		6 months after surgery
Secondary	Pathological assessment of response to neoadjuvant treatment	Replacement of the tumor by fibrous or fibro-inflammatory granulation tissue	1 months after surgery
Secondary	Surgical complication		60 days after surgery
Secondary	Length of hospital stay		60 days after surgery
Secondary	Quality of life (EORTC QLQ-C30)	QLQ (quality of life questionnaire)	before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery
Secondary	Quality of life (EORTC QLQ-C38)		before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery
Secondary	Toxicity of chemotherapy	Toxicity : incidence of chemotherapy-related adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) v4.0	1 year
Secondary	Incidence of completion of chemotherapy		1 year
Secondary	Accuracy of CT staging		1 year
Secondary	Total cycles of perioperative chemotherapy		1 year
Secondary	Pathological tumor stage	Colon cancer stage by AJCC 8th edition	1 month after surgery