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

Information source: Japan Clinical Oncology Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Neoplasms

Intervention: 5FU+l-leucovorin (Drug); UFT+Leucovorin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Japan Clinical Oncology Group

Official(s) and/or principal investigator(s):
Yoshihiro Moriya, MD, Study Chair, Affiliation: National Cancer Center Hospital

Summary

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

Clinical Details

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

Primary outcome: Disease-free survival

Secondary outcome:

Overall survival

Rate of adverse event

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

Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Locations and Contacts

Aichi Cancer Center Hospital, 1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi 464-8681, Japan

Fujita Health University, 1-98,Dengakugakubo,Kutsukake-cho,Toyoake, Aichi 470-1192, Japan

Jyuntendo Urayasu Hospital, 2-1-1,Tomioka,Urayasu, Chiba 279-0021, Japan

Toho University Sakura Hospital, 564-1,Shimoshidu,Sakura, Chiba 285-8741, Japan

National Cancer Center Hospital East, 6-5-1,Kashiwanoha,Kashiwa, Chiba 277-8577, Japan

Chiba Cancer Center Hospital, 666-2,Nitona-cho,Chuo-ku,Chiba, Chiba 260-8717, Japan

National Hospital Organization Shikoku Cancer Center, 13,Horinouchi,Matsuyama, Ehime 790-0007, Japan

Kurume University Medical Center, 155-1,Kokubumachi,Kurume, Fukuoka 839-0863, Japan

National Kyushu Cancer Center, 3-1-1,Notame,Minami-ku,Fukuoka, Fukuoka 811-1395, Japan

Kurume University School of Medicine, 67,Asahi-machi,Kurume, Fukuoka 830-0011, Japan

Gunma Prefectural Cancer Center, 617-1,Takabayashi-nishi-cho,Ota, Gunma 373-8550, Japan

Hiroshima University, School of Medicine, 1-2-3,Kasumi,Minami-ku,Hiroshima, Hiroshima 734-8551, Japan

Hiroshima City Hospital, 7-33,Motomachi,Naka-ku,Hiroshima, Hiroshima 730-8518, Japan

Sapporo-Kosei General Hospital, North-3,East8-5,Chuou-ku,Sapporo, Hokkaido 060-0033, Japan

Kansai Rosai Hospital, 3-1-69,Inabasou,Amagasaki, Hyogo 660-8511, Japan

Ibaraki Kenritsu Chuo Hospital & Cancer Center, 6528,Koibuchi,Tomobemachi,Nishi-ibarakigun, Ibaraki 309-1793, Japan

Ishikawa Prefectual Central Hospital, 2-1,Kuratsuki-Higashi,Kanazawa, Ishikawa 920-8530, Japan

Kanagawa Cancer Center, 1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa 241-0815, Japan

Kitasato University School of Medichine, 1-15-1,Kitasato,Sagamihara, Kanagawa 228-8555, Japan

Kitasato University East Hospital, 2-1-1,Asamizodai,Sagamihara, Kanagawa 228-8520, Japan

Teikyo University Hospital, Mizonokuchi, 3-8-3,Mizonokuchi,Takatsu-ku,Kawasaki, Kanagawa 213-8507, Japan

Showa University Northern Yokohama Hospital, 35-1,Chigasakichuo,Tsuzuki-ku,Yokohama, Kanagawa 224-8503, Japan

Yokohama City University Medical Center, 4-57,Urafunecho,Minami-ku,Yokohama, Kanagawa 232-0024, Japan

National Hospital Organization Kyoto Medical Center, 1-1,Mukaihata-cho,Fukakusa,Fushimi-ku,Kyoto, Kyoto 612-8555, Japan

Miyagi Cancer Center, 47-1,Nodayama,Medeshima-Shiode,Natori, Miyagi 981-1293, Japan

Nagano Municipal Hospital, 1333-1,Tomitake,Nagano, Nagano 381-8551, Japan

Niigata Cancer Center Hospital, 2-15-3,Kawagishi-cho,Niigata, Niigata 951-8566, Japan

Oita University Fuculty of Medicine, 1-1,Oogaoka,Hasama-machi,Oita, Oita 879-5593, Japan

Okayama Saiseikai General Hospital, 1-17-18,Ifukucho,Okayama, Okayama 700-8511, Japan

Sakai Municipal Hospital, 1-1-1,Minamiyasuicho,Sakai, Osaka 590-0064, Japan

Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3,Nakamichi,Higashinari-ku,Osaka, Osaka 537-8511, Japan

Osaka National Hospital, 2-1-14,Hoenzaka,Chuo-ku,Osaka, Osaka 540-0006, Japan

Osaka City General Hospital, 2-13-22,Miyakojimahondori,Miyakojima-ku,Osaka, Osaka 534-0021, Japan

Osaka University Graduate School of Medicine, 2-2,Yamada-oka,Suita, Osaka 565-0871, Japan

Osaka Medical College, 2-7,Daigakucho,Takatsuki, Osaka 569-0801, Japan

Minoh City Hospital, 5-7-1,Kayano,Minoh, Osaka 562-8562, Japan

Omiya Medical Center, Jichi Medical School, 1-847,Amanuma-cho,Omiya-ku,Saitama, Saitama 330-8503, Japan

National Defense Medical College, 3-2,Namiki,Tokorozawa, Saitama 359-8513, Japan

Sizuoka Cancer Center, 1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777, Japan

Tochigi Cancer Center, 4-9-13,Yohnan,Utsunomiya, Tochigi 320-0834, Japan

Tokyo Medical and Dental University Hospital, 1-5-45,Yushima,Bunkyo-ku, Tokyo 113-8519, Japan

Toho University Ohashi Hospital, 2-17-6,Ohashi,Meguro-ku, Tokyo 153-0044, Japan

Toranomon Hospital, 2-2-2,Toranomon,Minato-ku, Tokyo 105-8470, Japan

Keio University Hospital, 35,Shinanomachi,Shinjuku-ku, Tokyo 160-8582, Japan

National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

Kyorin University School of Medicine, 6-20-2,Shinkawa,Mitaka, Tokyo 181-8611, Japan

Tokyo Medical University, 6-7-1,Nishi-shinjuku,Shinjuku-ku, Tokyo 160-0023, Japan

Yamagata Prefectural Central Hospital, 1800,Aoyagi,Yamagata, Yamagata 990-2292, Japan

Additional Information

Starting date: February 2003
Last updated: February 2, 2009

Page last updated: August 20, 2015

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