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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 has been completed.
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group Identifier:
First received: September 12, 2005
Last updated: September 20, 2016
Last verified: September 2016
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
  • Rate of adverse event [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]

Enrollment: 1101
Study Start Date: February 2003
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: 5FU+l-leucovorin
Experimental: 2
Drug: UFT+Leucovorin

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.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00190515

Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
Fujita Health University
Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan, 470-1192
Chiba Cancer Center Hospital
Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan, 260-8717
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
Toho University Sakura Hospital
Sakura,Shimoshidu,564-1, Chiba, Japan, 285-8741
Jyuntendo Urayasu Hospital
Urayasu,Tomioka,2-1-1, Chiba, Japan, 279-0021
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
National Kyushu Cancer Center
Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan, 811-1395
Kurume University School of Medicine
Kurume,Asahi-machi,67, Fukuoka, Japan, 830-0011
Kurume University Medical Center
Kurume,Kokubumachi,155-1, Fukuoka, Japan, 839-0863
Gunma Prefectural Cancer Center
Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan, 373-8550
Hiroshima University, School of Medicine
Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, Japan, 734-8551
Hiroshima City Hospital
Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan, 730-8518
Sapporo-Kosei General Hospital
North-3,East8-5,Chuou-ku,Sapporo, Hokkaido, Japan, 060-0033
Kansai Rosai Hospital
Amagasaki,Inabasou,3-1-69, Hyogo, Japan, 660-8511
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan, 309-1793
Ishikawa Prefectual Central Hospital
Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa, Japan, 920-8530
Teikyo University Hospital, Mizonokuchi
Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3, Kanagawa, Japan, 213-8507
Kitasato University East Hospital
Sagamihara,Asamizodai,2-1-1, Kanagawa, Japan, 228-8520
Kitasato University School of Medichine
Sagamihara,Kitasato,1-15-1, Kanagawa, Japan, 228-8555
Yokohama City University Medical Center
Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, Japan, 232-0024
Kanagawa Cancer Center
Yokohama,Nakao,Asahi-ku,1-1-2, Kanagawa, Japan, 241-0815
Showa University Northern Yokohama Hospital
Yokohama,Tsuzuki-ku,Chigasakichuo,35-1, Kanagawa, Japan, 224-8503
National Hospital Organization Kyoto Medical Center
Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1, Kyoto, Japan, 612-8555
Miyagi Cancer Center
Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan, 981-1293
Nagano Municipal Hospital
Nagano,Tomitake,1333-1, Nagano, Japan, 381-8551
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
Oita University Fuculty of Medicine
Oita,Hasama-machi,Oogaoka,1-1, Oita, Japan, 879-5593
Okayama Saiseikai General Hospital
Okayama,Ifukucho,1-17-18, Okayama, Japan, 700-8511
Minoh City Hospital
Minoh,Kayano,5-7-1, Osaka, Japan, 562-8562
Osaka National Hospital
Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan, 540-0006
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
Osaka City General Hospital
Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan, 534-0021
Sakai Municipal Hospital
Sakai,Minamiyasuicho,1-1-1, Osaka, Japan, 590-0064
Osaka University Graduate School of Medicine
Suita,Yamada-oka,2-2, Osaka, Japan, 565-0871
Osaka Medical College
Takatsuki,Daigakucho,2-7, Osaka, Japan, 569-0801
Omiya Medical Center, Jichi Medical School
Saitama,Omiya-ku,Amanuma-cho,1-847, Saitama, Japan, 330-8503
National Defense Medical College
Tokorozawa,Namiki,3-2, Saitama, Japan, 359-8513
Sizuoka Cancer Center
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan, 411-8777
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, Japan, 320-0834
Tokyo Medical and Dental University Hospital
Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan, 113-8519
National Cancer Center Hospital
Chuo-ku, Tsukiji, 5-1-1, Tokyo, Japan, 104-0045
Toho University Ohashi Hospital
Meguro-ku,Ohashi,2-17-6, Tokyo, Japan, 153-0044
Toranomon Hospital
Minato-ku,Toranomon,2-2-2, Tokyo, Japan, 105-8470
Kyorin University School of Medicine
Mitaka,Shinkawa,6-20-2, Tokyo, Japan, 181-8611
Tokyo Medical University
Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, Japan, 160-0023
Keio University Hospital
Shinjuku-ku,Shinanomachi,35, Tokyo, Japan, 160-8582
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, Japan, 990-2292
Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Study Chair: Yoshihiro Moriya, MD National Cancer Center Hospital
  More Information

Additional Information:
Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group Identifier: NCT00190515     History of Changes
Other Study ID Numbers: JCOG-0205-MF  C000000193 
Study First Received: September 12, 2005
Last Updated: September 20, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
adjuvant chemotherapy
Stage III colorectal cancer
randomized controlled trial

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Protective Agents
Physiological Effects of Drugs processed this record on October 21, 2016