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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190515
• Other study ID #: JCOG-0205-MF
• Secondary ID: C000000193
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: September 20, 2016
• Start date: February 2003
• Est. completion date: November 2011

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1101
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• 5FU+l-leucovorin
5FU+l-leucovorin
• UFT+Leucovorin
UFT+Leucovorin

Locations

Country	Name	City	State
Japan	Kansai Rosai Hospital	Amagasaki,Inabasou,3-1-69	Hyogo
Japan	Tokyo Medical and Dental University Hospital	Bunkyo-ku,Yushima,1-5-45	Tokyo
Japan	Chiba Cancer Center Hospital	Chiba,Chuo-ku,Nitona-cho,666-2	Chiba
Japan	National Cancer Center Hospital	Chuo-ku, Tsukiji, 5-1-1	Tokyo
Japan	National Kyushu Cancer Center	Fukuoka,Minami-ku,Notame,3-1-1	Fukuoka
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	Ishikawa Prefectual Central Hospital	Kanazawa,Kuratsuki-Higashi,2-1	Ishikawa
Japan	National Cancer Center Hospital East	Kashiwa,Kashiwanoha,6-5-1	Chiba
Japan	Teikyo University Hospital, Mizonokuchi	Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3	Kanagawa
Japan	Kurume University School of Medicine	Kurume,Asahi-machi,67	Fukuoka
Japan	Kurume University Medical Center	Kurume,Kokubumachi,155-1	Fukuoka
Japan	National Hospital Organization Kyoto Medical Center	Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1	Kyoto
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama,Horinouchi,13	Ehime
Japan	Toho University Ohashi Hospital	Meguro-ku,Ohashi,2-17-6	Tokyo
Japan	Toranomon Hospital	Minato-ku,Toranomon,2-2-2	Tokyo
Japan	Minoh City Hospital	Minoh,Kayano,5-7-1	Osaka
Japan	Kyorin University School of Medicine	Mitaka,Shinkawa,6-20-2	Tokyo
Japan	Nagano Municipal Hospital	Nagano,Tomitake,1333-1	Nagano
Japan	Aichi Cancer Center Hospital	Nagoya,Chikusa-ku,Kanokoden,1-1	Aichi
Japan	Miyagi Cancer Center	Natori,Medeshima-Shiode,Nodayama,47-1	Miyagi
Japan	Niigata Cancer Center Hospital	Niigata,Kawagishi-cho,2-15-3	Niigata
Japan	Ibaraki Kenritsu Chuo Hospital & Cancer Center	Nishi-ibarakigun,Tomobemachi,Koibuchi,6528	Ibaraki
Japan	Sapporo-Kosei General Hospital	North-3,East8-5,Chuou-ku,Sapporo	Hokkaido
Japan	Oita University Fuculty of Medicine	Oita,Hasama-machi,Oogaoka,1-1	Oita
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 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	Gunma Prefectural Cancer Center	Ota,Takabayashi-nishi-cho,617-1	Gunma
Japan	Kitasato University East Hospital	Sagamihara,Asamizodai,2-1-1	Kanagawa
Japan	Kitasato University School of Medichine	Sagamihara,Kitasato,1-15-1	Kanagawa
Japan	Omiya Medical Center, Jichi Medical School	Saitama,Omiya-ku,Amanuma-cho,1-847	Saitama
Japan	Sakai Municipal Hospital	Sakai,Minamiyasuicho,1-1-1	Osaka
Japan	Toho University Sakura Hospital	Sakura,Shimoshidu,564-1	Chiba
Japan	Tokyo Medical University	Shinjuku-ku,Nishi-shinjuku,6-7-1	Tokyo
Japan	Keio University Hospital	Shinjuku-ku,Shinanomachi,35	Tokyo
Japan	Osaka University Graduate School of Medicine	Suita,Yamada-oka,2-2	Osaka
Japan	Sizuoka Cancer Center	Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007	Shizuoka
Japan	Osaka Medical College	Takatsuki,Daigakucho,2-7	Osaka
Japan	National Defense Medical College	Tokorozawa,Namiki,3-2	Saitama
Japan	Fujita Health University	Toyoake,Kutsukake-cho,Dengakugakubo,1-98	Aichi
Japan	Jyuntendo Urayasu Hospital	Urayasu,Tomioka,2-1-1	Chiba
Japan	Tochigi Cancer Center	Utsunomiya,Yohnan,4-9-13	Tochigi
Japan	Yamagata Prefectural Central Hospital	Yamagata,Aoyagi,1800	Yamagata
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

Sponsors (2)

Lead Sponsor	Collaborator
Haruhiko Fukuda	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		during the study conduct	No
Secondary	Overall survival		during the study conduct	No
Secondary	Rate of adverse event		during the study conduct	Yes

External Links

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