Identifying Prognostic Factors in Patients Receiving Tegafur-Uracil for Stage II Colon Cancer That Was Completely Removed By Surgery
- Registration Number
- NCT00898846
- Lead Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Brief Summary
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict which patients will respond to treatment.
PURPOSE: This laboratory study is looking at prognostic factors in patients receiving tegafur-uracil for stage II colon cancer that was completely removed by surgery.
- Detailed Description
OBJECTIVES:
* Identify the prognostic factors in patients with curatively resected stage II colon cancer receiving adjuvant chemotherapy with tegafur-uracil.
* Identify predictive factors of chemosensitivity to this regimen in these patients.
OUTLINE: Available tumor tissue samples are analyzed by real-time reverse transcriptase-PCR for TS, DPD, TP, OPRT, VEGF, cyclooxygenase-2, and FPGS; by PCR for microsatellite instability and genomic deletions on chromosome arm 18q; and pathologically for tumor budding, Crohn's-like lymphoid reaction, category of extent of poor differentiation, and fibrotic cancer stroma. The candidate prognostic and predictive markers are analyzed for correlation with disease-free survival, relapse-free survival, and overall survival of patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1111
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description UFT adjuvant therapy group UFT adjuvant chemotherapy UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year. During protocol treatment, clinical findings and laboratory values are evaluated every month. After the completion of protocol treatment, patients are followed-up, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.
- Primary Outcome Measures
Name Time Method mRNA levels 9years mRNA levels of patients are analyzed by the Danenberg tumor profile (DTP) method in the following indicators: thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), thymidine phosphorylase (TP), orotate phosphoribosyltransferase (OPRT), folylpolyglutamate synthetase (FPGS) vascular endothelial growth factor (VEGF), and cyclooxygenase-2 (Cox-2) mRNA levels.
- Secondary Outcome Measures
Name Time Method Analysis of microsatellite instability (MSI) and chromosomal instability (CIN) At enrollment MSI and CIN (i.e., 18q LOH) are analyzed using paraffin embedded samples.
Histopathological examination At enrollment Tumor budding, category of extent of poor differentiation, Crohn's-like lymphoid reaction, and fibrotic cancer stroma are analyzed using hematoxylin and eosin (H\&E) staining of paraffin embedded samples.
Trial Locations
- Locations (152)
Saitama Social Insurance Hospital
🇯🇵Saitama, Japan
Ban Buntane Houtokukai Hospital
🇯🇵Nagoya, Aichi, Japan
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Nagoya Midori Municipal Hospital
🇯🇵Nagoya, Aichi, Japan
Kurume University School of Medicine
🇯🇵Kurume, Fukuoka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima-shi, Fukushima, Japan
Nagoya Ekisaikai Hospital
🇯🇵Nagoya, Aichi, Japan
Aichi Prefectural Hospital
🇯🇵Okazaki, Aichi, Japan
Yamamoto Kumiai General Hospital
🇯🇵Noshiro, Akita, Japan
Social Insurance Tagawa Hospital
🇯🇵Tagawa, Fukuoka, Japan
Gifu Municipal Hospital
🇯🇵Gifu-shi, Gifu, Japan
Hashima City Hospital
🇯🇵Hashima, Gifu, Japan
Ogaki Municipal Hospital
🇯🇵Ogaki-shi, Gifu, Japan
Nagoya University School of Medicine
🇯🇵Nagoya, Aichi, Japan
Teikyo University Chiba Medical Center
🇯🇵Ichihara, Chiba, Japan
Asahi General Hospital
🇯🇵Inba-gunn, Chiba, Japan
Kyushu University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Saint Mary's Hospital
🇯🇵Kurume, Fukuoka, Japan
Hiraka General Hospital
🇯🇵Yokote, Akita, Japan
Fukuiken Saiseikai Hospital
🇯🇵Fukui-shi, Fukui, Japan
University of Fukui Hospital
🇯🇵Yoshida-gun, Fukui, Japan
Kitakyushu Municipal Medical Center
🇯🇵Kitakyushu, Fukuoka, Japan
Gunma Cancer Center
🇯🇵Otashi, Gunma, Japan
Miyoshi Central Hospital
🇯🇵Miyoshi, Hiroshima, Japan
Gunma University Graduate School of Medicine
🇯🇵Maebashi-shi, Gunma, Japan
Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers
🇯🇵Fukuyama, Hiroshima, Japan
Asahikawa Medical College
🇯🇵Asahikawa, Hokkaido, Japan
Otaru Ekisaikai Hospital
🇯🇵Asahikawa, Hokkaido, Japan
National Hospital Organization Fukuyama Medical Center
🇯🇵Fukuyama, Hiroshima, Japan
National Hospital Organization Kure Medical Center
🇯🇵Kure, Hiroshima, Japan
Hirosaki University, School of Medicine
🇯🇵Otaru-shi, Hokkaido, Japan
Hokkaido University Graduate School of Medicine
🇯🇵Sapporo, Hokkaido, Japan
Kobe University Hospital
🇯🇵Kobe, Hyogo, Japan
Hakodate Goryoukaku Hospital
🇯🇵Hakodate, Hokkaido, Japan
Sapporo City General Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Cancer Center
🇯🇵Akashi, Hyogo, Japan
Sapporo Medical University
🇯🇵Sapporo, Hokkaido, Japan
Ako City Hospital
🇯🇵Akou, Hyogo, Japan
Takarazuka Municipal Hospital
🇯🇵Takarazuka, Hyogo, Japan
Himeji St. Mary's Hospital
🇯🇵Himeji, Hyogo, Japan
Himeji Central Hospital
🇯🇵Himeji, Hyogo, Japan
Kobe West City Hospital
🇯🇵Kobe, Hyogo, Japan
Kagawa University Hospital
🇯🇵Miki, Kagawa, Japan
Hyogo Prefectural Amagasaki Hospital
🇯🇵Amagasaki, Hyogo, Japan
Kakogawa Municipal Hospital
🇯🇵Kakogawa, Hyogo, Japan
Kansai Rosai Hospital
🇯🇵Amagasaki, Hyogo, Japan
Kobe City General Hospital
🇯🇵Kobe-shi, Hyogo, Japan
Higashi Takarazuka Satoh Hospital
🇯🇵Takarazukai, Hyogo, Japan
Nishi-Kobe Medical Center
🇯🇵Kobe, Hyogo, Japan
Sano Hospital
🇯🇵Kobe, Hyogo, Japan
Hyogo Prefectural Awaji Hospital
🇯🇵Sumoto, Hyogo, Japan
Kobe Medical Center
🇯🇵Kobe, Hyogo, Japan
Hyogo College of Medicine
🇯🇵Nishinomiya, Hyogo, Japan
Kagawa Prefectural Central Hospital
🇯🇵Takamatsu, Kagawa, Japan
Kanagawa Prefectural Ashigawa-kami Hospital
🇯🇵Ashigarakami-gun, Kanagawa, Japan
Chigasaki Municipal Hospital
🇯🇵Chigasaki, 253-0083, Kanagawa, Japan
Kanto Rosai Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Yokohama City Hospital
🇯🇵Yokohama, Kanagawa, Japan
Kanagawa Cancer Center
🇯🇵Yokohama, Kanagawa, Japan
International Goodwill Hospital
🇯🇵Yokohama, Kanagawa, Japan
Kochi Medical School
🇯🇵Nankoku, Kochi, Japan
National Hospital Organization - Kumamotominami Hospital
🇯🇵Uki, Kumamoto, Japan
Yatsushiro Health Insurance General Hospital
🇯🇵Yatsushiro, Kumamoto, Japan
Kyoto Second Red Cross Hospital
🇯🇵Kanigyou-ku, Kyoto, Japan
Mie University Graduate School of Medicine
🇯🇵Thu-shi, Mie, Japan
Miyagi Cancer Center
🇯🇵Natori-shi, Miyagi, Japan
Tohoku Rosai Hospital
🇯🇵Sendai, Miyagi, Japan
Iida Municipal Hospital
🇯🇵Iida, Nagano, Japan
Showa-Inan General Hospital
🇯🇵Komagane, Nagano, Japan
Aizawa Hospital
🇯🇵Matsumoto, Nagano, Japan
Nagano Municipal Hospital
🇯🇵Nagano-shi, Nagano, Japan
Oita University Hospital
🇯🇵Yufu-shi, Oita, Japan
Hokushin Hospital
🇯🇵Nakano, Nagano, Japan
Minoh City Hospital
🇯🇵Mino, Osaka, Japan
Osaka City General Hospital
🇯🇵Osaka-shi, Osaka, Japan
Osaka Kosei Nenkin Hospital
🇯🇵Osaka-shi, Osaka, Japan
Kenseikai Nara Coloproctology Center
🇯🇵Yamatotakada, Nara, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata-shi, Niigata, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata-shi, Niigata, Japan
Osaka General Medical Center
🇯🇵Osaka-shi, Osaka, Japan
Kurashiki Central Hospital
🇯🇵Kurashiki, Okayama, Japan
Rinku General Medical Center
🇯🇵Izumisano, Osaka, Japan
Osaka Medical College
🇯🇵Takatsuki, Osaka, Japan
Saitama Medical School Hospital
🇯🇵Kawagoe-shi, Saitama, Japan
Hoshigaoka Koseinenkin Hospital
🇯🇵Hirakata, Osaka, Japan
Osaka Police Hospital
🇯🇵Osaka-shi, Osaka, Japan
Osaka Rosai Hospital
🇯🇵Sakai-shi, Osaka, Japan
Suita Municipal Hospital
🇯🇵Suita-shi, Osaka, Japan
Fukaya Red Cross Hospital
🇯🇵Fukaya, Saitama, Japan
Shimane Prefectural Central Hospital
🇯🇵Izumo-shi, Shimane, Japan
Saiseikai Tondabayashi Hospital
🇯🇵Tondabayashi, Osaka, Japan
Fujieda Municipal General Hospital
🇯🇵Fujieda, Shizuoka, Japan
Shouwa General Hospital
🇯🇵Kodaira, Tokyo, Japan
Koseiren Takaoka Hospital
🇯🇵Takaoka-shi, Toyama, Japan
University of Yamanashi Faculty of Medicine
🇯🇵Chu-o-shi, Yamanashi, Japan
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Japanese Red Cross Kumamoto Hospital
🇯🇵Kumamoto, Japan
Tokyo Women's Medical University
🇯🇵Shinjyuku-ku, Tokyo, Japan
Yaizu Municipal Hospital
🇯🇵Yaizu, Shizuoka, Japan
Hasuda Hospital
🇯🇵Hasuda, Saitama, Japan
National Defense Medical College
🇯🇵Tokorozawa, Saitama, Japan
Tochigi Cancer Center
🇯🇵Utsunomiya, Tochigi, Japan
Social Insurance Kinan Hospital
🇯🇵Tanabe, Wakayama, Japan
National Hospital Organization Mito Medical Center
🇯🇵Ibaraki, Japan
Nagahama City Hospital
🇯🇵Nagahama, Shiga, Japan
Otsu Municipal Hospital
🇯🇵Otsu, Shiga, Japan
Hamamatsu University School of Medicine
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Jichi Medical School
🇯🇵Shimotsuke-shi, Tochigi, Japan
Anan Kyoei Hospital
🇯🇵Anan, Tokushima, Japan
St. Luke's International Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Tokyo Metropolitan Fuchu Hospital
🇯🇵Fuchu, Tokyo, Japan
Daisan Hospital
🇯🇵Komae, Tokyo, Japan
Kyorin University School of Medicine - Mitaka Campus
🇯🇵Mitaka, Tokyo, Japan
Shimonoseki Kosei Hospital
🇯🇵Shimonoseki, Yamaguchi, Japan
Yamaguchi University Graduate School of Medicine
🇯🇵Ube, Yamaguchi, Japan
Matsunami General Hospital
🇯🇵Gifu, Japan
Social Insurance Chuo General Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Tottori University - Faculty of Medicine
🇯🇵Yonago, Tottori, Japan
Nanpuh Hospital
🇯🇵Kagoshima, Japan
National Hospital Organization - Kanmon Medical Center
🇯🇵Shimonoseki, Yamaguchi, Japan
Chiba Cancer Center
🇯🇵Chiba, Japan
Kitasato University School of Medicine
🇯🇵Kanagawa, Japan
Kumamoto University Faculty of Medical and Pharmaceutical Sciences
🇯🇵Kumamoto, Japan
Nishijin Hospital
🇯🇵Kyoto, Japan
Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Nagasaki University Hospital
🇯🇵Nagasaki, Japan
Saiseikai Niigata Daini Hospital
🇯🇵Niigata, Japan
Osaka City Juso Hospital
🇯🇵Osaka, Japan
Itabashi Chuo Medical Center
🇯🇵Tokyo, Japan
Nagano Red Cross Hospital
🇯🇵Nagano, Japan
Okayama University Medical School
🇯🇵Okayama, Japan
Kitano Hospital
🇯🇵Osaka, Japan
Osaka Red Cross Hospital
🇯🇵Osaka, Japan
Yamagata Prefectural Central Hospital
🇯🇵Yamagata, Japan
Saiseikai Nara Hospital
🇯🇵Nara, Japan
Higashi Sumiyoshi Morimoto Hospital
🇯🇵Osaka, Japan
Nissay Hospital
🇯🇵Osaka, Japan
Minamiosaka Hospital
🇯🇵Osaka, Japan
Takasago Kyoritsu Hospital
🇯🇵Tokyo, Japan
Otemae Hospital
🇯🇵Osaka, Japan
Mita Hospital at the International University of Health and Welfare
🇯🇵Tokyo, Japan
Japanese Red Cross Medical Center
🇯🇵Tokyo, Japan
Osaka Saiseikai Noe Hospital
🇯🇵Osaka, Japan
Shizuoka City Hospital
🇯🇵Shizuoka, Japan
Shizuoka Municipal Shimizu Hospital
🇯🇵Shizuoka, Japan
Tokyo Medical and Dental University
🇯🇵Tokyo, Japan
Nippon Medical School
🇯🇵Tokyo, Japan
Toho University School of Medicine
🇯🇵Tokyo, Japan
International Medical Center of Japan
🇯🇵Tokyo, Japan
Teikyo University School of Medicine
🇯🇵Tokyo, Japan
Yamagata University Hospital
🇯🇵Yamagata, Japan