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Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer

Primary Purpose

Colon Cancer

Status

Recruiting

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Neoadjuvant FOLFOX

Conventional adjuvant FOLFOX

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Chonnam National University Hwasun HospitalRecruiting
Kyungpook National University Chilgok HospitalRecruiting
Asan Medical CenterRecruiting
The Catholic Univ. of Korea St. Vincent's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neoadjuvant FOLFOX

Conventional adjuvant FOLFOX

Arm Description

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

surgery followed by 12 cycles of FOLFOX

Outcomes

Primary Outcome Measures

Relapse free survival after randomization

Secondary Outcome Measures

Overall survival

Radiological assessment of response to neoadjuvant treatment

Pathological assessment of response to neoadjuvant treatment

Replacement of the tumor by fibrous or fibro-inflammatory granulation tissue

Surgical complication

Length of hospital stay

Quality of life (EORTC QLQ-C30)

QLQ (quality of life questionnaire)

Quality of life (EORTC QLQ-C38)

Toxicity of chemotherapy

Toxicity : incidence of chemotherapy-related adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) v4.0

Incidence of completion of chemotherapy

Accuracy of CT staging

Total cycles of perioperative chemotherapy

Pathological tumor stage

Colon cancer stage by AJCC 8th edition

Full Information

NCT ID

NCT03426904

First Posted

January 23, 2018

Last Updated

March 12, 2023

Sponsor

Kyungpook National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03426904

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 24, 2018 (Actual)

Primary Completion Date

December 31, 2026 (Anticipated)

Study Completion Date

December 28, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyungpook National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neoadjuvant FOLFOX

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional adjuvant FOLFOX

Arm Type

Active Comparator

Arm Description

surgery followed by 12 cycles of FOLFOX

Intervention Type

Drug

Intervention Name(s)

Neoadjuvant FOLFOX

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Conventional adjuvant FOLFOX

Intervention Description

12 cycles of postoperative FOLFOX chemotherapy

Primary Outcome Measure Information:

Title

Relapse free survival after randomization

Time Frame

3 years after randomization

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

3 year after randomization

Title

Radiological assessment of response to neoadjuvant treatment

Time Frame

6 months after surgery

Title

Pathological assessment of response to neoadjuvant treatment

Description

Replacement of the tumor by fibrous or fibro-inflammatory granulation tissue

Time Frame

1 months after surgery

Title

Surgical complication

Time Frame

60 days after surgery

Title

Length of hospital stay

Time Frame

60 days after surgery

Title

Quality of life (EORTC QLQ-C30)

Description

QLQ (quality of life questionnaire)

Time Frame

before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery

Title

Quality of life (EORTC QLQ-C38)

Time Frame

before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery

Title

Toxicity of chemotherapy

Description

Toxicity : incidence of chemotherapy-related adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) v4.0

Time Frame

1 year

Title

Incidence of completion of chemotherapy

Time Frame

1 year

Title

Accuracy of CT staging

Time Frame

1 year

Title

Total cycles of perioperative chemotherapy

Time Frame

1 year

Title

Pathological tumor stage

Description

Colon cancer stage by AJCC 8th edition

Time Frame

1 month after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Soo Yeun Park, MD

Phone

+82-53-200-2166

psy-flower@daumm.net

First Name & Middle Initial & Last Name or Official Title & Degree

Gyu-Seog Choi, MD, PhD

Phone

+82-53-200-2166

kyuschoi@mail.knu.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Soo Yeun Park, MD

Organizational Affiliation

Kyungpook National University Chilgok Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Gyu-Seog Choi, MD, PhD

Organizational Affiliation

Kyungpook National University Chilgok Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chonnam National University Hwasun Hospital

City

Hwasun

State/Province

Chonnam

ZIP/Postal Code

58128

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chang Hyun Kim, MD

cksantiago8@gmail.com

First Name & Middle Initial & Last Name & Degree

Chang Hyun Kim, MD

First Name & Middle Initial & Last Name & Degree

Hyong Rok Kim, MD

Facility Name

Kyungpook National University Chilgok Hospital

City

Daegu

ZIP/Postal Code

41404

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Soo Yeun Park, MD

psy-flower@daum.net

First Name & Middle Initial & Last Name & Degree

Soo Yeun Park, MD

First Name & Middle Initial & Last Name & Degree

Gyu-Seog Choi, MD

First Name & Middle Initial & Last Name & Degree

Jun Seog Park, MD

First Name & Middle Initial & Last Name & Degree

Hye Jin Kim, MD

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

In Ja Park, MD

ipark@amc.seoul.kr

First Name & Middle Initial & Last Name & Degree

In Ja Park, MD

Facility Name

The Catholic Univ. of Korea St. Vincent's Hospital

City

Suwon-si

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bong-Hyeon Kye, M.D.

ggbong@catholic.ac.kr

First Name & Middle Initial & Last Name & Degree

Hyeon Min Cho, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer

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