Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer

Sponsor

Kyungpook National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03426904

Collaborator

(none)

560

Enrollment

Locations

Arms

88.2

Anticipated Duration (Months)

140

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer	Drug: Neoadjuvant FOLFOX Drug: Conventional adjuvant FOLFOX	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

560 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 24, 2018

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Feb 28, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neoadjuvant FOLFOX 4 cycles of FOLFOX (Folinic acid, fluorouracil and oxaliplatin) neoadjuvant followed by surgery and 8 cycles of FOLFOX	Drug: Neoadjuvant FOLFOX 4 cycles of FOLFOX neoadjuvant chemotherapy and 8 cycles of postoperative chemotherapy
Active Comparator: Conventional adjuvant FOLFOX surgery followed by 12 cycles of FOLFOX	Drug: Conventional adjuvant FOLFOX 12 cycles of postoperative FOLFOX chemotherapy

Arm

Intervention/Treatment

Experimental: Neoadjuvant FOLFOX

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

Drug: Neoadjuvant FOLFOX

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

Active Comparator: Conventional adjuvant FOLFOX

surgery followed by 12 cycles of FOLFOX

Drug: Conventional adjuvant FOLFOX

12 cycles of postoperative FOLFOX chemotherapy

Outcome Measures

Primary Outcome Measures

Relapse free survival after randomization [3 years after randomization]

Secondary Outcome Measures

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]
Replacement of the tumor by fibrous or fibro-inflammatory granulation tissue
Surgical complication [60 days 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)
Quality of life (EORTC QLQ-C38) [before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year 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
Incidence of completion of chemotherapy [1 year]
Accuracy of CT staging [1 year]
Total cycles of perioperative chemotherapy [1 year]
Pathological tumor stage [1 month after surgery]
Colon cancer stage by AJCC 8th edition

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chonnam National University Hwasun Hospital	Hwasun	Chonnam	Korea, Republic of	58128
2	Kyungpook National University Chilgok Hospital	Daegu		Korea, Republic of	41404
3	Asan Medical Center	Seoul		Korea, Republic of	05505
4	The Catholic Univ. of Korea St. Vincent's Hospital	Suwon-si		Korea, Republic of

Sponsors and Collaborators

Kyungpook National University Hospital

Investigators

Study Director: Soo Yeun Park, MD, Kyungpook National University Chilgok Hospital
Principal Investigator: Gyu-Seog Choi, MD, PhD, Kyungpook National University Chilgok Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gyu-Seog Choi, Kyungpook National University Hospital, Kyungpook National University Hospital

ClinicalTrials.gov Identifier:

NCT03426904

Other Study ID Numbers:

KNUHCRC006

First Posted:

Feb 8, 2018

Last Update Posted:

Dec 22, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 22, 2020