Colon CancerPhase 3ECTXNCT01460589
Early Commencement of Adjuvant Chemotherapy for Colon Cancer
A Phase 3 study testing timing to initiate the adjuvant FOLFOX chemotherapy in people with Colon Cancer, run by Kyungpook National University Hospital at 2 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- timing to initiate the adjuvant FOLFOX chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 13 Jan 2013to 28 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Kyungpook National University Medical center
Daegu, 41404
Jun Seok Park
Daegu
About this study
Official title: Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Trial
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.
Read more
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.
Read the detailed description
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
- 2,400mg/m2 over 46 hours
- Conditions
- Colon Cancer
- Being tested
- timing to initiate the adjuvant FOLFOX chemotherapy
- Keywords
- colon cancer, Chemotherapy, adjuvant
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
timing to initiate the adjuvant FOLFOX chemotherapyDrug
Also called early commencement of chemotherapy
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
| Study group | Role | What they receive |
|---|---|---|
| early commencement | Experimental | Individuals who initiate the adjuvant chemotherapy from 10 to 14 days after surgery Receives: Drug: timing to initiate the adjuvant FOLFOX chemotherapy |
| conventional commencement | Active comparator | Individuals who initiate the adjuvant chemotherapy after 14 days after surgery Receives: Drug: timing to initiate the adjuvant FOLFOX chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 years after operation
Secondary outcomes (2)
short-term cumulative surgery-related complications during chemotherapy
A comparison of the postoperative recovery variables, the postoperative complications and mortality
Measured: up to 26 weeks after operation
side effects of chemotherapy
check Anemia, Leukopenia, Neutropenia, Thrombocytopenia, Edema, Fever, Insomnia, Asthenia, Anorexia, Nausea, Vomiting, Constipation, Diarrhea, Hand foot syndrome, Dyspepsia, Creatinine, AST, ALT, Bilirubin, abdominal pain, GI bleeding, diarrhea
Measured: during chemotherapy period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study start13 Jan 2013
- Primary completion19 Jun 2024
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gyu-Seog Choi, Kyungpook National University Hospital
- Investigators
- Jun Seok Park, M.D.Ph.D, Study chair, Kyunpook National Univercity Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460589
- Sponsor's protocol ID
- KNUHCRC004
- Acronym
- ECTX
- Status last verified
- Feb 2026
- First submitted
- 25 Oct 2011
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT01460589
- Acronym / sponsor ID
- ECTX / KNUHCRC004
- Conditions
- Colon Cancer
- Keywords
- colon cancer, Chemotherapy, adjuvant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 13 Jan 2013 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 27 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- 2,400mg/m2 over 46 hours
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early commencement | Experimental | Drug: timing to initiate the adjuvant FOLFOX chemotherapyIndividuals who initiate the adjuvant chemotherapy from 10 to 14 days after surgery |
| conventional commencement | Active comparator | Drug: timing to initiate the adjuvant FOLFOX chemotherapyIndividuals who initiate the adjuvant chemotherapy after 14 days after surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| timing to initiate the adjuvant FOLFOX chemotherapyAlso: early commencement of chemotherapyChemotherapy 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 | Drug | conventional commencement, early commencement |
Primary outcome
3-year disease free survival rate
Time frame: up to 3 years after operation
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.
2 secondary outcomes
short-term cumulative surgery-related complications during chemotherapy
Time frame: up to 26 weeks after operation
side effects of chemotherapy
Time frame: during chemotherapy period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Seok Park, M.D.Ph.D study chair
Kyunpook National Univercity Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing timing to initiate the adjuvant FOLFOX chemotherapy in people with Colon Cancer, run by Kyungpook National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival rate (time frame: up to 3 years after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.