Clinical trial NCT00190515: A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Neoplasms
Keywords: adjuvant chemotherapy
Stage III colorectal cancer
5-FU+l-LV
UFT+LV
randomized controlled trial
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-09-19
Enrollment: 1101
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Disease-free survival
timeFrame: during the study conduct
Secondary outcomes:
measure: Overall survival
timeFrame: during the study conduct
measure: Rate of adverse event
timeFrame: during the study conduct
Other outcomes:
Locations:
city: Nagoya,Chikusa-ku,Kanokoden,1-1
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Toyoake,Kutsukake-cho,Dengakugakubo,1-98
country: Japan
facility: Fujita Health University
state: Aichi
city: Chiba,Chuo-ku,Nitona-cho,666-2
country: Japan
facility: Chiba Cancer Center Hospital
state: Chiba
city: Kashiwa,Kashiwanoha,6-5-1
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Sakura,Shimoshidu,564-1
country: Japan
facility: Toho University Sakura Hospital
state: Chiba
city: Urayasu,Tomioka,2-1-1
country: Japan
facility: Jyuntendo Urayasu Hospital
state: Chiba
city: Matsuyama,Horinouchi,13
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Fukuoka,Minami-ku,Notame,3-1-1
country: Japan
facility: National Kyushu Cancer Center
state: Fukuoka
city: Kurume,Asahi-machi,67
country: Japan
facility: Kurume University School of Medicine
state: Fukuoka
city: Kurume,Kokubumachi,155-1
country: Japan
facility: Kurume University Medical Center
state: Fukuoka
city: Ota,Takabayashi-nishi-cho,617-1
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Hiroshima,Minami-ku,Kasumi,1-2-3
country: Japan
facility: Hiroshima University, School of Medicine
state: Hiroshima
city: Hiroshima,Naka-ku,Motomachi,7-33
country: Japan
facility: Hiroshima City Hospital
state: Hiroshima
city: North-3,East8-5,Chuou-ku,Sapporo
country: Japan
facility: Sapporo-Kosei General Hospital
state: Hokkaido
city: Amagasaki,Inabasou,3-1-69
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Nishi-ibarakigun,Tomobemachi,Koibuchi,6528
country: Japan
facility: Ibaraki Kenritsu Chuo Hospital & Cancer Center
state: Ibaraki
city: Kanazawa,Kuratsuki-Higashi,2-1
country: Japan
facility: Ishikawa Prefectual Central Hospital
state: Ishikawa
city: Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3
country: Japan
facility: Teikyo University Hospital, Mizonokuchi
state: Kanagawa
city: Sagamihara,Asamizodai,2-1-1
country: Japan
facility: Kitasato University East Hospital
state: Kanagawa
city: Sagamihara,Kitasato,1-15-1
country: Japan
facility: Kitasato University School of Medichine
state: Kanagawa
city: Yokohama,Minami-ku,Urafunecho,4-57
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Yokohama,Nakao,Asahi-ku,1-1-2
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Yokohama,Tsuzuki-ku,Chigasakichuo,35-1
country: Japan
facility: Showa University Northern Yokohama Hospital
state: Kanagawa
city: Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1
country: Japan
facility: National Hospital Organization Kyoto Medical Center
state: Kyoto
city: Natori,Medeshima-Shiode,Nodayama,47-1
country: Japan
facility: Miyagi Cancer Center
state: Miyagi
city: Nagano,Tomitake,1333-1
country: Japan
facility: Nagano Municipal Hospital
state: Nagano
city: Niigata,Kawagishi-cho,2-15-3
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Oita,Hasama-machi,Oogaoka,1-1
country: Japan
facility: Oita University Fuculty of Medicine
state: Oita
city: Okayama,Ifukucho,1-17-18
country: Japan
facility: Okayama Saiseikai General Hospital
state: Okayama
city: Minoh,Kayano,5-7-1
country: Japan
facility: Minoh City Hospital
state: Osaka
city: Osaka,Chuo-ku,Hoenzaka,2-1-14
country: Japan
facility: Osaka National Hospital
state: Osaka
city: Osaka,Higashinari-ku,Nakamichi,1-3-3
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
state: Osaka
city: Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22
country: Japan
facility: Osaka City General Hospital
state: Osaka
city: Sakai,Minamiyasuicho,1-1-1
country: Japan
facility: Sakai Municipal Hospital
state: Osaka
city: Suita,Yamada-oka,2-2
country: Japan
facility: Osaka University Graduate School of Medicine
state: Osaka
city: Takatsuki,Daigakucho,2-7
country: Japan
facility: Osaka Medical College
state: Osaka
city: Saitama,Omiya-ku,Amanuma-cho,1-847
country: Japan
facility: Omiya Medical Center, Jichi Medical School
state: Saitama
city: Tokorozawa,Namiki,3-2
country: Japan
facility: National Defense Medical College
state: Saitama
city: Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007
country: Japan
facility: Sizuoka Cancer Center
state: Shizuoka
city: Utsunomiya,Yohnan,4-9-13
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Bunkyo-ku,Yushima,1-5-45
country: Japan
facility: Tokyo Medical and Dental University Hospital
state: Tokyo
city: Chuo-ku, Tsukiji, 5-1-1
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Meguro-ku,Ohashi,2-17-6
country: Japan
facility: Toho University Ohashi Hospital
state: Tokyo
city: Minato-ku,Toranomon,2-2-2
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Mitaka,Shinkawa,6-20-2
country: Japan
facility: Kyorin University School of Medicine
state: Tokyo
city: Shinjuku-ku,Nishi-shinjuku,6-7-1
country: Japan
facility: Tokyo Medical University
state: Tokyo
city: Shinjuku-ku,Shinanomachi,35
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Yamagata,Aoyagi,1800
country: Japan
facility: Yamagata Prefectural Central Hospital
state: Yamagata
Study officials:
affiliation: National Cancer Center Hospital
name: Yoshihiro Moriya, MD
role: STUDY_CHAIR
References: