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Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling by invite only)
Colon Cancer

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Trial Information

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

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3-year disease free survival rate

Outcome Description:

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.

Outcome Time Frame:

up to 3 years after operation

Safety Issue:


Principal Investigator

Gyu seog Choi, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Kyunpook National Univercity Medical Center


South Korea: Institutional Review Board

Study ID:




Start Date:

November 2011

Completion Date:

October 2015

Related Keywords:

  • Colon Cancer
  • colon cancer
  • Chemotherapy
  • adjuvant
  • Colonic Neoplasms