NCT01460589

Brief Summary

This study sets up the final study end point and three detailed goals as the following. The main objective of study: This trial is done to assess the safety and benefit of early adjuvant chemotherapy from 10 to 14 days after surgery compared with conventional commencement after 2weeks for treatment of patients with colon cancer. Detailed goal of study: The primary endpoint: This study is designed to assess whether early commencement of adjuvant chemotherapy improves the 3-year disease-free survival, overall survival and recurrence rate. The secondary endpoint: This study aims to compare short-term cumulative complications between early and conventional commencement of adjuvant chemotherapy after laparoscopic resection of colon cancer. This study will also assess the quality of life and side effects of chemotherapy.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P50-P75 for phase_3

Timeline
7mo left

Started Jan 2013

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jan 2013Dec 2026

First Submitted

Initial submission to the registry

October 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 13, 2013

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2024

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2026

Expected
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

11.4 years

First QC Date

October 25, 2011

Last Update Submit

February 10, 2026

Conditions

Colon Cancer

Keywords

colon cancerChemotherapyadjuvant

Outcome Measures

Primary Outcomes (1)

  • 3-year disease free survival rate

    A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.

    up to 3 years after operation

Secondary Outcomes (2)

  • short-term cumulative surgery-related complications during chemotherapy

    up to 26 weeks after operation

  • side effects of chemotherapy

    during chemotherapy period

Study Arms (2)

early commencement

EXPERIMENTAL

Individuals who initiate the adjuvant chemotherapy from 10 to 14 days after surgery

Drug: timing to initiate the adjuvant FOLFOX chemotherapy

conventional commencement

ACTIVE COMPARATOR

Individuals who initiate the adjuvant chemotherapy after 14 days after surgery

Drug: timing to initiate the adjuvant FOLFOX chemotherapy

Interventions

timing to initiate the adjuvant FOLFOX chemotherapyDRUG

Chemotherapy regimen: FOLFOX-6, every 2weeks, total 12 cycles treatment day1: Oxaliplatin 85mg/m2 day1: Leucovorin 200mg/m2 day1: 5-FU 400mg/m2 IV bolus and 2,400mg/m2 over 46 hours

Also known as: early commencement of chemotherapy
conventional commencementearly commencement

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligibility rule of enrollment
  • Rectal adenocarcinoma that were 15 cm or more from the anal verge
  • pathologically diagnosed stage II or III disease
  • patients who meet the discharge criteria within 10days after surgery
  • Patients with adequate hepatic, renal, and bone marrow function, and a left ventricular ejection fraction of 55% or higher measured by echocardiography

You may not qualify if:

  • An ineligibility to participate in the clinical study based on the judgment of investigators from a legal perspective
  • A past history of chemotherapy
  • tumor with obstruction or perforation
  • tumor with distant metastases
  • synchronous tumor
  • relative or absolute contraindications of chemotherapy
  • Recent MI, CVA, nitrate medication
  • Severe cardiovascular disease, psychiatric disease
  • Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
  • Renal dysfunction (Cr ≥2mg/dl)
  • The concurrent presence of other severe medical diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kyungpook National University Medical center

Daegu, 41404, South Korea

Location

Jun Seok Park

Daegu, South Korea

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Jun Seok Park, M.D.Ph.D

    Kyunpook National Univercity Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 25, 2011

First Posted

October 27, 2011

Study Start

January 13, 2013

Primary Completion

June 19, 2024

Study Completion (Estimated)

December 28, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations

KR(2)