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A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Japan Clinical Oncology Group
Japanese Ministry of Health, Labor and Welfare
Information provided by: Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00190515
  Purpose

To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy for stage III colorectal cancer.


Condition Intervention Phase
Colorectal Neoplasms
Drug: 5FU+l-leucovorin
Drug: UFT+Leucovorin
Phase III

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized Phase III Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • Disease-free survival

Secondary Outcome Measures:
  • Overall survival
  • Rate of adverse event

Estimated Enrollment: 1100
Study Start Date: February 2003
Estimated Study Completion Date: November 2011
Detailed Description:

Oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy for curatively resected colorectal cancer in Japan. In order to evaluate a clinical benefit of oral anticancer drugs in adjuvant chemotherapy, we conducted randomized controlled trial comparing the oral combination chemotherapy, UFT+LV, to the standard intravenous combination chemotherapy, 5-FU+l-LV, in stage III colorectal cancer.

UFT+LV: UFT 300mg/m2/day and LV 75mg/day, orally for 28days with 7days rest, repeated five times every 5 weeks.

5-FU+l-LV: 5-FU 500mg/m2, l-LV 250mg/m2, weekly administration for 6 times, repeated three times every 8 weeks.

Primary endpoints are disease-free survival and secondary endpoints are overall survival and adverse event rate.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically proved colorectal cancer (either adenocarcinoma, mucinous carcinoma, or signet-ring cell carcinoma).
  2. Tumor is mainly located in between cecum and upper rectum, excluding that invades to lower rectum.
  3. Stage III cancer by General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus (6th ed.), excluding si(ai), n(-), M(-).
  4. No synchronous colorectal cancer which invade muscularis propria or deeper.
  5. Tumor resection with D2 or D3 lymph node dissection was performed.
  6. Pathological determination of curability of tumor resection is cur A.
  7. Age at registration is above 20 and below 75 years old.
  8. ECOG Performance status is 0 or 1.
  9. No prior chemotherapy or radiation therapy.
  10. Intake of normal diet and oral drugs is possible.
  11. Major organ function is preserved. WBC>=3,000/mcl, PLT>=100,000/mcl, GOT<=100 IU/L, GPT<=100 IU/L, T.Bil <=2.0 mg/dl, Cr<=1.5 mg/dl
  12. Adjuvant chemotherapy can be started within 9 weeks after surgery.
  13. Written informed consent is taken.

Exclusion Criteria:

  1. Active co-existing malignancy (synchronous or metachronous malignancy whose disease free period is within 5 years). Carcinoma in situ is eligible.
  2. Severe postoperative complications which do not resolve until registration.
  3. There is following complication. insulin-controlling or uncontrollable diabetes mellitus, uncontrollable hypertension, myocardial infarction within six month or unstable angina pectoris, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe emphysema
  4. Pregnant or breast-feeding woman.
  5. Difficult to participate with the trial, having mental disorder or psychiatric symptoms.
  6. Judged to be inappropriate to register.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190515

  Show 48 Study Locations
Sponsors and Collaborators
Japan Clinical Oncology Group
Japanese Ministry of Health, Labor and Welfare
Investigators
Study Chair: Yoshihiro Moriya, MD National Cancer Center Hospital
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: JCOG-0205-MF, C000000193
Study First Received: September 12, 2005
Last Updated: May 31, 2007
ClinicalTrials.gov Identifier: NCT00190515  
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
adjuvant chemotherapy
Stage III colorectal cancer
5-FU+l-LV
UFT+LV
randomized controlled trial

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Fluorouracil
Colonic Diseases
Leucovorin
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Vitamin B Complex
Neoplasms by Site
Growth Substances
Vitamins
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009