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Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer

Phase 2
15 Years
75 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer

A multicenter Open-label, single-arm feasibility study is conducted on patients with
histological stage IV colorectal cancer given oxaliplatin, leucovorin plus fluorouracil. The
usefulness of this regimens as therapy for colorectal cancer was evaluated by the
disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of
adverse event.

Inclusion Criteria:

1. Histological diagnosis of colorectral adenocarcinoma.

2. Measurable or assessable lesions.

3. Age: 15 ~ 75 years.

4. Performance Status (ECOG): 0 ~ 2.

5. Prior chemotherapy within 2 regimens.

6. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC
3,500/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the
upper limit of normal (excluding liver metastasis). T-Bil 3.0mg/dl. Creatinine
within the upper limit of normal. Normal ECG (not considering clinically unimportant
arrhythmias and ischemic changes).

(10) Predicted survival for >8 weeks. (11) Able to give written informed consent.

Exclusion Criteria:

1. Severe pleural effusion or ascites.

2. Metastasis to the central nervous system (CNS).

3. Active gastrointestinal bleeding.

4. Active infection.

5. Uncontrolled ischemic heart disease.

6. Serious complications (such as intestinal paralysis, intestinal obstruction,
interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart
failure, renal failure, or hepatic failure).

7. Active multiple cancer.

8. Severe mental disorder.

9. Pregnancy, possible pregnancy, or breast-feeding.

10. Patients with neuropathy ≥ grade 2

11. Judged to be ineligible for this protocol by the attending physician.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence and severity of adverse event

Principal Investigator

Masahiro Asaka, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hokkaido Gastrointestinal Cancer Study Group


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

January 2005

Completion Date:

June 2007

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms