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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Japan Clinical Oncology Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00190515
First received: September 12, 2005
Last updated: February 2, 2009
Last verified: February 2009
  Purpose

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


Condition Intervention Phase
Colorectal Neoplasms
Drug: 5FU+l-leucovorin
Drug: UFT+Leucovorin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
  • Rate of adverse event [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]

Enrollment: 1101
Study Start Date: February 2003
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
5-FU/l-LV
Drug: 5FU+l-leucovorin
5FU+l-leucovorin
Experimental: 2
UFT/LV
Drug: UFT+Leucovorin
UFT+Leucovorin

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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190515

Locations
Japan
Aichi Cancer Center Hospital
1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan, 464-8681
Fujita Health University
1-98,Dengakugakubo,Kutsukake-cho,Toyoake, Aichi, Japan, 470-1192
Jyuntendo Urayasu Hospital
2-1-1,Tomioka,Urayasu, Chiba, Japan, 279-0021
Toho University Sakura Hospital
564-1,Shimoshidu,Sakura, Chiba, Japan, 285-8741
National Cancer Center Hospital East
6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan, 277-8577
Chiba Cancer Center Hospital
666-2,Nitona-cho,Chuo-ku,Chiba, Chiba, Japan, 260-8717
National Hospital Organization Shikoku Cancer Center
13,Horinouchi,Matsuyama, Ehime, Japan, 790-0007
Kurume University Medical Center
155-1,Kokubumachi,Kurume, Fukuoka, Japan, 839-0863
National Kyushu Cancer Center
3-1-1,Notame,Minami-ku,Fukuoka, Fukuoka, Japan, 811-1395
Kurume University School of Medicine
67,Asahi-machi,Kurume, Fukuoka, Japan, 830-0011
Gunma Prefectural Cancer Center
617-1,Takabayashi-nishi-cho,Ota, Gunma, Japan, 373-8550
Hiroshima University, School of Medicine
1-2-3,Kasumi,Minami-ku,Hiroshima, Hiroshima, Japan, 734-8551
Hiroshima City Hospital
7-33,Motomachi,Naka-ku,Hiroshima, Hiroshima, Japan, 730-8518
Sapporo-Kosei General Hospital
North-3,East8-5,Chuou-ku,Sapporo, Hokkaido, Japan, 060-0033
Kansai Rosai Hospital
3-1-69,Inabasou,Amagasaki, Hyogo, Japan, 660-8511
Ibaraki Kenritsu Chuo Hospital & Cancer Center
6528,Koibuchi,Tomobemachi,Nishi-ibarakigun, Ibaraki, Japan, 309-1793
Ishikawa Prefectual Central Hospital
2-1,Kuratsuki-Higashi,Kanazawa, Ishikawa, Japan, 920-8530
Kanagawa Cancer Center
1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan, 241-0815
Kitasato University School of Medichine
1-15-1,Kitasato,Sagamihara, Kanagawa, Japan, 228-8555
Kitasato University East Hospital
2-1-1,Asamizodai,Sagamihara, Kanagawa, Japan, 228-8520
Teikyo University Hospital, Mizonokuchi
3-8-3,Mizonokuchi,Takatsu-ku,Kawasaki, Kanagawa, Japan, 213-8507
Showa University Northern Yokohama Hospital
35-1,Chigasakichuo,Tsuzuki-ku,Yokohama, Kanagawa, Japan, 224-8503
Yokohama City University Medical Center
4-57,Urafunecho,Minami-ku,Yokohama, Kanagawa, Japan, 232-0024
National Hospital Organization Kyoto Medical Center
1-1,Mukaihata-cho,Fukakusa,Fushimi-ku,Kyoto, Kyoto, Japan, 612-8555
Miyagi Cancer Center
47-1,Nodayama,Medeshima-Shiode,Natori, Miyagi, Japan, 981-1293
Nagano Municipal Hospital
1333-1,Tomitake,Nagano, Nagano, Japan, 381-8551
Niigata Cancer Center Hospital
2-15-3,Kawagishi-cho,Niigata, Niigata, Japan, 951-8566
Oita University Fuculty of Medicine
1-1,Oogaoka,Hasama-machi,Oita, Oita, Japan, 879-5593
Okayama Saiseikai General Hospital
1-17-18,Ifukucho,Okayama, Okayama, Japan, 700-8511
Sakai Municipal Hospital
1-1-1,Minamiyasuicho,Sakai, Osaka, Japan, 590-0064
Osaka Medical Center for Cancer and Cardiovascular Diseases
1-3-3,Nakamichi,Higashinari-ku,Osaka, Osaka, Japan, 537-8511
Osaka National Hospital
2-1-14,Hoenzaka,Chuo-ku,Osaka, Osaka, Japan, 540-0006
Osaka City General Hospital
2-13-22,Miyakojimahondori,Miyakojima-ku,Osaka, Osaka, Japan, 534-0021
Osaka University Graduate School of Medicine
2-2,Yamada-oka,Suita, Osaka, Japan, 565-0871
Osaka Medical College
2-7,Daigakucho,Takatsuki, Osaka, Japan, 569-0801
Minoh City Hospital
5-7-1,Kayano,Minoh, Osaka, Japan, 562-8562
Omiya Medical Center, Jichi Medical School
1-847,Amanuma-cho,Omiya-ku,Saitama, Saitama, Japan, 330-8503
National Defense Medical College
3-2,Namiki,Tokorozawa, Saitama, Japan, 359-8513
Sizuoka Cancer Center
1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
Tochigi Cancer Center
4-9-13,Yohnan,Utsunomiya, Tochigi, Japan, 320-0834
Tokyo Medical and Dental University Hospital
1-5-45,Yushima,Bunkyo-ku, Tokyo, Japan, 113-8519
Toho University Ohashi Hospital
2-17-6,Ohashi,Meguro-ku, Tokyo, Japan, 153-0044
Toranomon Hospital
2-2-2,Toranomon,Minato-ku, Tokyo, Japan, 105-8470
Keio University Hospital
35,Shinanomachi,Shinjuku-ku, Tokyo, Japan, 160-8582
National Cancer Center Hospital
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045
Kyorin University School of Medicine
6-20-2,Shinkawa,Mitaka, Tokyo, Japan, 181-8611
Tokyo Medical University
6-7-1,Nishi-shinjuku,Shinjuku-ku, Tokyo, Japan, 160-0023
Yamagata Prefectural Central Hospital
1800,Aoyagi,Yamagata, Yamagata, Japan, 990-2292
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Yoshihiro Moriya, MD National Cancer Center Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00190515     History of Changes
Other Study ID Numbers: JCOG-0205-MF, C000000193
Study First Received: September 12, 2005
Last Updated: February 2, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
adjuvant chemotherapy
Stage III colorectal cancer
5-FU+l-LV
UFT+LV
randomized controlled trial

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014