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

Phase 3

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: 5FU+l-leucovorin; Drug: UFT+Leucovorin

• Registration Number: NCT00190515
• Lead Sponsor: Haruhiko Fukuda

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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	5FU+l-leucovorin	5-FU/l-LV
2	UFT+Leucovorin	UFT/LV

Primary Outcome Measures

Name	Time	Method
Disease-free survival	during the study conduct

Secondary Outcome Measures

Name	Time	Method
Rate of adverse event	during the study conduct
Overall survival	during the study conduct

Trial Locations

Locations (48)

Sapporo-Kosei General Hospital; 🇯🇵 North-3,East8-5,Chuou-ku,Sapporo, Hokkaido, Japan

Nagano Municipal Hospital; 🇯🇵 Nagano,Tomitake,1333-1, Nagano, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

Ishikawa Prefectual Central Hospital; 🇯🇵 Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa, Japan

Kansai Rosai Hospital; 🇯🇵 Amagasaki,Inabasou,3-1-69, Hyogo, Japan

National Hospital Organization Shikoku Cancer Center; 🇯🇵 Matsuyama,Horinouchi,13, Ehime, Japan

Aichi Cancer Center Hospital; 🇯🇵 Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan

Kurume University School of Medicine; 🇯🇵 Kurume,Asahi-machi,67, Fukuoka, Japan

Kurume University Medical Center; 🇯🇵 Kurume,Kokubumachi,155-1, Fukuoka, Japan

Osaka Medical Center for Cancer and Cardiovascular Diseases; 🇯🇵 Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 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

Kyorin University School of Medicine; 🇯🇵 Mitaka,Shinkawa,6-20-2, Tokyo, Japan

Fujita Health University; 🇯🇵 Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan

Chiba Cancer Center Hospital; 🇯🇵 Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan

Jyuntendo Urayasu Hospital; 🇯🇵 Urayasu,Tomioka,2-1-1, Chiba, Japan

National Kyushu Cancer Center; 🇯🇵 Fukuoka,Minami-ku,Notame,3-1-1, 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

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

Niigata Cancer Center Hospital; 🇯🇵 Niigata,Kawagishi-cho,2-15-3, Niigata, Japan

Okayama Saiseikai General Hospital; 🇯🇵 Okayama,Ifukucho,1-17-18, Okayama, Japan

Osaka National Hospital; 🇯🇵 Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan

Osaka University Graduate School of Medicine; 🇯🇵 Suita,Yamada-oka,2-2, Osaka, Japan

Yamagata Prefectural Central Hospital; 🇯🇵 Yamagata,Aoyagi,1800, Yamagata, Japan

Toho University Ohashi Hospital; 🇯🇵 Meguro-ku,Ohashi,2-17-6, Tokyo, Japan

Toranomon Hospital; 🇯🇵 Minato-ku,Toranomon,2-2-2, Tokyo, Japan

Toho University Sakura Hospital; 🇯🇵 Sakura,Shimoshidu,564-1, Chiba, Japan

Hiroshima City Hospital; 🇯🇵 Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan

Ibaraki Kenritsu Chuo Hospital & Cancer Center; 🇯🇵 Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan

Yokohama City University Medical Center; 🇯🇵 Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, Japan

Osaka City General Hospital; 🇯🇵 Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan

National Defense Medical College; 🇯🇵 Tokorozawa,Namiki,3-2, Saitama, Japan

Keio University Hospital; 🇯🇵 Shinjuku-ku,Shinanomachi,35, Tokyo, Japan

Teikyo University Hospital, Mizonokuchi; 🇯🇵 Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3, Kanagawa, Japan

Kitasato University School of Medichine; 🇯🇵 Sagamihara,Kitasato,1-15-1, Kanagawa, Japan

Miyagi Cancer Center; 🇯🇵 Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, 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

Kitasato University East Hospital; 🇯🇵 Sagamihara,Asamizodai,2-1-1, Kanagawa, Japan

Oita University Fuculty of Medicine; 🇯🇵 Oita,Hasama-machi,Oogaoka,1-1, Oita, Japan

Minoh City Hospital; 🇯🇵 Minoh,Kayano,5-7-1, Osaka, Japan

Sakai Municipal Hospital; 🇯🇵 Sakai,Minamiyasuicho,1-1-1, Osaka, Japan

National Cancer Center Hospital; 🇯🇵 Chuo-ku, Tsukiji, 5-1-1, Tokyo, Japan

Tokyo Medical University; 🇯🇵 Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, Japan