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

NCT ID: NCT00190515

Last Updated: 2016-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2011-11-30

Brief Summary

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

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.

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

5-FU/l-LV

Group Type: ACTIVE_COMPARATOR

5FU+l-leucovorin

Intervention Type: DRUG

5FU+l-leucovorin

2

UFT/LV

Group Type: EXPERIMENTAL

UFT+Leucovorin

Intervention Type: DRUG

UFT+Leucovorin

Interventions

5FU+l-leucovorin

5FU+l-leucovorin

Intervention Type: DRUG

UFT+Leucovorin

UFT+Leucovorin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role: collaborator

Haruhiko Fukuda

OTHER

Sponsor Role: lead

Responsible Party

Haruhiko Fukuda

JCOG Data Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yoshihiro Moriya, MD

Role: STUDY_CHAIR

National Cancer Center Hospital

Locations

Aichi Cancer Center Hospital

Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan

Fujita Health University

Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, Japan

Chiba Cancer Center Hospital

Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan

National Cancer Center Hospital East

Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

Toho University Sakura Hospital

Sakura,Shimoshidu,564-1, Chiba, Japan

Jyuntendo Urayasu Hospital

Urayasu,Tomioka,2-1-1, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama,Horinouchi,13, Ehime, Japan

National Kyushu Cancer Center

Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan

Kurume University School of Medicine

Kurume,Asahi-machi,67, Fukuoka, Japan

Kurume University Medical Center

Kurume,Kokubumachi,155-1, Fukuoka, Japan

Gunma Prefectural Cancer Center

Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan

Hiroshima University, School of Medicine

Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, Japan

Hiroshima City Hospital

Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan

Sapporo-Kosei General Hospital

North-3,East8-5,Chuou-ku,Sapporo, Hokkaido, Japan

Kansai Rosai Hospital

Amagasaki,Inabasou,3-1-69, Hyōgo, Japan

Ibaraki Kenritsu Chuo Hospital & Cancer Center

Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan

Ishikawa Prefectual Central Hospital

Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa-ken, Japan

Teikyo University Hospital, Mizonokuchi

Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3, Kanagawa, Japan

Kitasato University East Hospital

Sagamihara,Asamizodai,2-1-1, Kanagawa, Japan

Kitasato University School of Medichine

Sagamihara,Kitasato,1-15-1, Kanagawa, Japan

Yokohama City University Medical Center

Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, Japan

Kanagawa Cancer Center

Yokohama,Nakao,Asahi-ku,1-1-2, Kanagawa, Japan

Showa University Northern Yokohama Hospital

Yokohama,Tsuzuki-ku,Chigasakichuo,35-1, Kanagawa, Japan

National Hospital Organization Kyoto Medical Center

Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1, Kyoto, Japan

Miyagi Cancer Center

Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan

Nagano Municipal Hospital

Nagano,Tomitake,1333-1, Nagano, Japan

Niigata Cancer Center Hospital

Niigata,Kawagishi-cho,2-15-3, Niigata, Japan

Oita University Fuculty of Medicine

Oita,Hasama-machi,Oogaoka,1-1, Oita Prefecture, Japan

Okayama Saiseikai General Hospital

Okayama,Ifukucho,1-17-18, Okayama-ken, Japan

Minoh City Hospital

Minoh,Kayano,5-7-1, Osaka, Japan

Osaka National Hospital

Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan

Osaka City General Hospital

Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan

Sakai Municipal Hospital

Sakai,Minamiyasuicho,1-1-1, Osaka, Japan

Osaka University Graduate School of Medicine

Suita,Yamada-oka,2-2, Osaka, Japan

Osaka Medical College

Takatsuki,Daigakucho,2-7, Osaka, Japan

Omiya Medical Center, Jichi Medical School

Saitama,Omiya-ku,Amanuma-cho,1-847, Saitama, Japan

National Defense Medical College

Tokorozawa,Namiki,3-2, Saitama, Japan

Sizuoka Cancer Center

Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan

Tochigi Cancer Center

Utsunomiya,Yohnan,4-9-13, Tochigi, Japan

Tokyo Medical and Dental University Hospital

Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan

National Cancer Center Hospital

Chuo-ku, Tsukiji, 5-1-1, Tokyo, Japan

Toho University Ohashi Hospital

Meguro-ku,Ohashi,2-17-6, Tokyo, Japan

Toranomon Hospital

Minato-ku,Toranomon,2-2-2, Tokyo, Japan

Kyorin University School of Medicine

Mitaka,Shinkawa,6-20-2, Tokyo, Japan

Tokyo Medical University

Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, Japan

Keio University Hospital

Shinjuku-ku,Shinanomachi,35, Tokyo, Japan

Yamagata Prefectural Central Hospital

Yamagata,Aoyagi,1800, Yamagata, Japan

Countries

Japan

Related Links

http://www.jcog.jp/

Related Info

Other Identifiers

C000000193

Identifier Type: -

Identifier Source: secondary_id

JCOG-0205-MF

Identifier Type: -

Identifier Source: org_study_id