Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00209703
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : April 21, 2006
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group

September 13, 2005
September 21, 2005
April 21, 2006
January 2005
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Incidence and severity of adverse event
Same as current
Complete list of historical versions of study NCT00209703 on Archive Site
Determine the clinical response rate, disease-free survival(DFS), overall survival(OS)
Same as current
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Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer
Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer
We performed a feasibility study of mFOLFOX6 in advanced colorectal cancer in Japan and to estimate the safety and efficacy of this regimen.
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.
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: Oxaliplatin
  • Drug: l-Leucovorin
  • Drug: 5-Fluorouracil
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2007
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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.
Sexes Eligible for Study: All
15 Years to 75 Years   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Hokkaido Gastrointestinal Cancer Study Group
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Study Chair: Masahiro Asaka, MD, PhD Hokkaido Gastrointestinal Cancer Study Group
Hokkaido Gastrointestinal Cancer Study Group
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP