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A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)

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.
 
ClinicalTrials.gov Identifier: NCT00190515
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 22, 2016
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group

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

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: 5FU+l-leucovorin Drug: UFT+Leucovorin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)
Study Start Date : February 2003
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
5-FU/l-LV
Drug: 5FU+l-leucovorin
5FU+l-leucovorin

Experimental: 2
UFT/LV
Drug: UFT+Leucovorin
UFT+Leucovorin




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: during the study conduct ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: during the study conduct ]
  2. Rate of adverse event [ Time Frame: during the study conduct ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190515


Locations
Show Show 48 study locations
Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Investigators
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Study Chair: Yoshihiro Moriya, MD National Cancer Center Hospital

Additional Information:
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Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00190515    
Other Study ID Numbers: JCOG-0205-MF
C000000193
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Keywords provided by Haruhiko Fukuda, Japan Clinical Oncology Group:
adjuvant chemotherapy
Stage III colorectal cancer
5-FU+l-LV
UFT+LV
randomized controlled trial
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents