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

NCT00190515 | Completed Phase 3 DMC

• 2 other identifiers: JCOG-0205-MFC000000193
• Study Type: interventional
• Target: 1,101
• Locations: 1 country
• Sites: 48

Brief Summary

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

Conditions

Colorectal Neoplasms

Keywords

adjuvant chemotherapy; Stage III colorectal cancer; 5-FU+l-LV; UFT+LV; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  during the study conduct

Secondary Outcomes (2)

• Overall survival

  during the study conduct

• Rate of adverse event

  during the study conduct

Study Arms (2)

1

ACTIVE COMPARATOR

5-FU/l-LV

Drug: 5FU+l-leucovorin

2

EXPERIMENTAL

UFT/LV

Drug: UFT+Leucovorin

Interventions

5FU+l-leucovorin DRUG

5FU+l-leucovorin

1

UFT+Leucovorin DRUG

UFT+Leucovorin

2

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proved colorectal cancer (either adenocarcinoma, mucinous carcinoma, or signet-ring cell carcinoma).
• Tumor is mainly located in between cecum and upper rectum, excluding that invades to lower rectum.
• 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(-).
• No synchronous colorectal cancer which invade muscularis propria or deeper.
• Tumor resection with D2 or D3 lymph node dissection was performed.
• Pathological determination of curability of tumor resection is cur A.
• Age at registration is above 20 and below 75 years old.
• ECOG Performance status is 0 or 1.
• No prior chemotherapy or radiation therapy.
• Intake of normal diet and oral drugs is possible.
• 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
• Adjuvant chemotherapy can be started within 9 weeks after surgery.
• Written informed consent is taken.

You may not qualify if:

• Active co-existing malignancy （synchronous or metachronous malignancy whose disease free period is within 5 years). Carcinoma in situ is eligible.
• Severe postoperative complications which do not resolve until registration.
• 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
• Pregnant or breast-feeding woman.
• Difficult to participate with the trial, having mental disorder or psychiatric symptoms.
• Judged to be inappropriate to register.

Sponsors & Collaborators

• Haruhiko Fukuda: lead
• Ministry of Health, Labour and Welfare, Japan: collaborator

Study Sites (48)

Aichi Cancer Center Hospital

Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681, Japan

Location

Fujita Health University

Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, 470-1192, Japan

Location

Chiba Cancer Center Hospital

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

Location

National Cancer Center Hospital East

Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577, Japan

Location

Toho University Sakura Hospital

Sakura,Shimoshidu,564-1, Chiba, 285-8741, Japan

Location

Jyuntendo Urayasu Hospital

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

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama,Horinouchi,13, Ehime, 790-0007, Japan

Location

National Kyushu Cancer Center

Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, 811-1395, Japan

Location

Kurume University School of Medicine

Kurume,Asahi-machi,67, Fukuoka, 830-0011, Japan

Location

Kurume University Medical Center

Kurume,Kokubumachi,155-1, Fukuoka, 839-0863, Japan

Location

Gunma Prefectural Cancer Center

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

Location

Hiroshima University, School of Medicine

Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, 734-8551, Japan

Location

Hiroshima City Hospital

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

Location

Sapporo-Kosei General Hospital

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

Location

Kansai Rosai Hospital

Amagasaki,Inabasou,3-1-69, Hyōgo, 660-8511, Japan

Location

Ibaraki Kenritsu Chuo Hospital & Cancer Center

Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, 309-1793, Japan

Location

Ishikawa Prefectual Central Hospital

Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa-ken, 920-8530, Japan

Location

Teikyo University Hospital, Mizonokuchi

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

Location

Kitasato University East Hospital

Sagamihara,Asamizodai,2-1-1, Kanagawa, 228-8520, Japan

Location

Kitasato University School of Medichine

Sagamihara,Kitasato,1-15-1, Kanagawa, 228-8555, Japan

Location

Yokohama City University Medical Center

Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, 232-0024, Japan

Location

Kanagawa Cancer Center

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

Location

Showa University Northern Yokohama Hospital

Yokohama,Tsuzuki-ku,Chigasakichuo,35-1, Kanagawa, 224-8503, Japan

Location

National Hospital Organization Kyoto Medical Center

Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1, Kyoto, 612-8555, Japan

Location

Miyagi Cancer Center

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

Location

Nagano Municipal Hospital

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

Location

Niigata Cancer Center Hospital

Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566, Japan

Location

Oita University Fuculty of Medicine

Oita,Hasama-machi,Oogaoka,1-1, Oita Prefecture, 879-5593, Japan

Location

Okayama Saiseikai General Hospital

Okayama,Ifukucho,1-17-18, Okayama-ken, 700-8511, Japan

Location

Minoh City Hospital

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

Location

Osaka National Hospital

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

Location

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511, Japan

Location

Osaka City General Hospital

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

Location

Sakai Municipal Hospital

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

Location

Osaka University Graduate School of Medicine

Suita,Yamada-oka,2-2, Osaka, 565-0871, Japan

Location

Osaka Medical College

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

Location

Omiya Medical Center, Jichi Medical School

Saitama,Omiya-ku,Amanuma-cho,1-847, Saitama, 330-8503, Japan

Location

National Defense Medical College

Tokorozawa,Namiki,3-2, Saitama, 359-8513, Japan

Location

Sizuoka Cancer Center

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

Location

Tochigi Cancer Center

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

Location

Tokyo Medical and Dental University Hospital

Bunkyo-ku,Yushima,1-5-45, Tokyo, 113-8519, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tsukiji, 5-1-1, Tokyo, 104-0045, Japan

Location

Toho University Ohashi Hospital

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

Location

Toranomon Hospital

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

Location

Kyorin University School of Medicine

Mitaka,Shinkawa,6-20-2, Tokyo, 181-8611, Japan

Location

Tokyo Medical University

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

Location

Keio University Hospital

Shinjuku-ku,Shinanomachi,35, Tokyo, 160-8582, Japan

Location

Yamagata Prefectural Central Hospital

Yamagata,Aoyagi,1800, Yamagata, 990-2292, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yoshihiro Moriya, MD

  National Cancer Center Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: JCOG Data Center

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: February 1, 2003
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

JP (48)