Identifying Prognostic Factors in Patients Receiving Tegafur-Uracil for Stage II Colon Cancer That Was Completely Removed By Surgery
Identification of the Prognostic Factors of Stage II Colon Cancer Patients Receiving Adjuvant Chemotherapy With UFT
2 other identifiers
observational
1,111
1 country
152
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2006
Longer than P75 for all trials
152 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 9, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedSeptember 28, 2016
September 1, 2016
9 years
May 9, 2009
September 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mRNA levels
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.
9years
Secondary Outcomes (2)
Analysis of microsatellite instability (MSI) and chromosomal instability (CIN)
At enrollment
Histopathological examination
At enrollment
Study Arms (2)
UFT adjuvant therapy group
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.
Observation group
Patients are followed-up without adjuvant treatment, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.
Interventions
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.
Eligibility Criteria
Patients with curatively resected stage II colon cancer in Japan.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (152)
Nagoya Ekisaikai Hospital
Nagoya, Aichi-ken, 454-8502, Japan
Ban Buntane Houtokukai Hospital
Nagoya, Aichi-ken, 454-8509, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8550, Japan
Nagoya University School of Medicine
Nagoya, Aichi-ken, 466, Japan
Nagoya Midori Municipal Hospital
Nagoya, Aichi-ken, Japan
Aichi Prefectural Hospital
Okazaki, Aichi-ken, Japan
Yamamoto Kumiai General Hospital
Noshiro, Akita, 016-0014, Japan
Hiraka General Hospital
Yokote, Akita, 013-8610, Japan
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
Teikyo University Chiba Medical Center
Ichihara, Chiba, 299-0111, Japan
Asahi General Hospital
Inba-gunn, Chiba, 270-1694, Japan
Fukuiken Saiseikai Hospital
Fukui-shi, Fukui, 918-8503, Japan
University of Fukui Hospital
Yoshida-gun, Fukui, 910-1193, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-0065, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Kitakyushu Municipal Medical Center
Kitakyushu, Fukuoka, 802-0077, Japan
Kurume University School of Medicine
Kurume, Fukuoka, 830-0011, Japan
Saint Mary's Hospital
Kurume, Fukuoka, 830-8543, Japan
Social Insurance Tagawa Hospital
Tagawa, Fukuoka, 826-8585, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295, Japan
Gifu Municipal Hospital
Gifu, Gifu, 500-8323, Japan
Matsunami General Hospital
Gifu, Gifu, 501-6062, Japan
Hashima City Hospital
Hashima, Gifu, 501-6206, Japan
Ogaki Municipal Hospital
Ogaki-shi, Gifu, 503-8502, Japan
Gunma University Graduate School of Medicine
Maebashi, Gunma, 371-8511, Japan
Gunma Cancer Center
Otashi, Gunma, 373-8550, Japan
National Hospital Organization Fukuyama Medical Center
Fukuyama, Hiroshima, 720-0825, Japan
Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers
Fukuyama, Hiroshima, 721-8581, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
National Hospital Organization Kure Medical Center
Kure, Hiroshima, 737-0023, Japan
Miyoshi Central Hospital
Miyoshi, Hiroshima, 728-8502, Japan
Asahikawa Medical College
Asahikawa, Hokkaido, 078-8510, Japan
Otaru Ekisaikai Hospital
Asahikawa, Hokkaido, 078-8510, Japan
Hakodate Goryoukaku Hospital
Hakodate, Hokkaido, 040-8611, Japan
Hirosaki University, School of Medicine
Otaru-shi, Hokkaido, 047-0031, Japan
Sapporo Medical University
Sapporo, Hokkaido, 060-8556, Japan
Sapporo City General Hospital
Sapporo, Hokkaido, 060-8604, Japan
Hokkaido University Graduate School of Medicine
Sapporo, Hokkaido, 060-8638, Japan
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558, Japan
Ako City Hospital
Akou, Hyōgo, 678-0232, Japan
Hyogo Prefectural Amagasaki Hospital
Amagasaki, Hyōgo, 660-0828, Japan
Kansai Rosai Hospital
Amagasaki, Hyōgo, 660-8511, Japan
Himeji St. Mary's Hospital
Himeji, Hyōgo, 670-0801, Japan
Himeji Central Hospital
Himeji, Hyōgo, 672-8501, Japan
Kakogawa Municipal Hospital
Kakogawa, Hyōgo, 675-8611, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Kobe City General Hospital
Kobe, Hyōgo, 650-0046, Japan
Nishi-Kobe Medical Center
Kobe, Hyōgo, 651-2273, Japan
Kobe West City Hospital
Kobe, Hyōgo, 653-0013, Japan
Kobe Medical Center
Kobe, Hyōgo, 654-0155, Japan
Sano Hospital
Kobe, Hyōgo, 655-0031, Japan
Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501, Japan
Hyogo Prefectural Awaji Hospital
Sumoto, Hyōgo, 656-0013, Japan
Takarazuka Municipal Hospital
Takarazuka, Hyōgo, 665-0827, Japan
Higashi Takarazuka Satoh Hospital
Takarazukai, Hyōgo, 665-0873, Japan
National Hospital Organization Mito Medical Center
Ibaraki, Ibaraki, 311-3193, Japan
Kagawa University Hospital
Hiragi, Kagawa-ken, 761-0793, Japan
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557, Japan
Nanpuh Hospital
Kagoshima, Kagoshima-ken, 892-8512, Japan
Kanagawa Prefectural Ashigawa-kami Hospital
Ashigarakami-gun, Kanagawa, 258-0003, Japan
Chigasaki Municipal Hospital
Chigasaki, 253-0083, Kanagawa, 253-0083, Japan
Kitasato University School of Medicine
Kanagawa, Kanagawa, 228-8555, Japan
Kanto Rosai Hospital
Kawasaki, Kanagawa, 211-8510, Japan
Yokohama City Hospital
Yokohama, Kanagawa, 240, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-0815, Japan
International Goodwill Hospital
Yokohama, Kanagawa, 245-0006, Japan
Kochi Medical School
Nankoku, Kochi, 783-8505, Japan
Kumamoto University Faculty of Medical and Pharmaceutical Sciences
Kumamoto, Kumamoto, 860-8556, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, 861-8520, Japan
National Hospital Organization - Kumamotominami Hospital
Uki, Kumamoto, 869-0, Japan
Yatsushiro Health Insurance General Hospital
Yatsushiro, Kumamoto, 866-8660, Japan
Kyoto Second Red Cross Hospital
Kanigyou-ku, Kyoto, 602-8026, Japan
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-0841, Japan
Nishijin Hospital
Kyoto, Kyoto, 602, Japan
Mie University Graduate School of Medicine
Thu-shi, Mie-ken, 514-8507, Japan
Miyagi Cancer Center
Natori-shi, Miyagi, 981-1293, Japan
Tohoku Rosai Hospital
Sendai, Miyagi, 981-0911, Japan
Iida Municipal Hospital
Iida, Nagano, 395-8502, Japan
Showa-Inan General Hospital
Komagane, Nagano, 399-4191, Japan
Aizawa Hospital
Matsumoto, Nagano, 390-8510, Japan
Nagano Red Cross Hospital
Nagano, Nagano, 380-0, Japan
Nagano Municipal Hospital
Nagano, Nagano, 381-8551, Japan
Hokushin Hospital
Nakano, Nagano, 383-0021, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Saiseikai Nara Hospital
Nara, Nara, 6308145, Japan
Kenseikai Nara Coloproctology Center
Yamatotakada, Nara, 635-0022, Japan
Saiseikai Niigata Daini Hospital
Niigata, Niigata, 950-1104, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8122, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
Oita University Hospital
Yufu-shi, Oita Prefecture, 879-5593, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, 710-8602, Japan
Okayama University Medical School
Okayama, Okayama-ken, 700-8558, Japan
Hoshigaoka Koseinenkin Hospital
Hirakata, Osaka, 573-8511, Japan
Rinku General Medical Center
Izumisano, Osaka, 598-8577, Japan
Minoh City Hospital
Mino, Osaka, 562-0014, Japan
Kitano Hospital
Osaka, Osaka, 530-8480, Japan
Osaka City Juso Hospital
Osaka, Osaka, 532-0, Japan
Osaka City General Hospital
Osaka, Osaka, 534-0021, Japan
Otemae Hospital
Osaka, Osaka, 540-0008, Japan
Osaka Police Hospital
Osaka, Osaka, 543-8502, Japan
Higashi Sumiyoshi Morimoto Hospital
Osaka, Osaka, 546-0012, Japan
Nissay Hospital
Osaka, Osaka, 550-0012, Japan
Osaka Kosei Nenkin Hospital
Osaka, Osaka, 553-0003, Japan
Osaka General Medical Center
Osaka, Osaka, 558-8558, Japan
Osaka Saiseikai Noe Hospital
Osaka, Osaka, Joto-ku, Japan
Minamiosaka Hospital
Osaka, Osaka, Japan
Osaka Rosai Hospital
Sakai-shi, Osaka, 591-8025, Japan
Suita Municipal Hospital
Suita-shi, Osaka, 564-0082, Japan
Osaka Medical College
Takatsuki, Osaka, 569-8686, Japan
Saiseikai Tondabayashi Hospital
Tondabayashi, Osaka, 584-0082, Japan
Fukaya Red Cross Hospital
Fukaya, Saitama, 366-0052, Japan
Hasuda Hospital
Hasuda, Saitama, 349-0123, Japan
Saitama Medical School Hospital
Kawagoe-shi, Saitama, 350-8550, Japan
Saitama Social Insurance Hospital
Saitama, Saitama, 330-0074, Japan
National Defense Medical College
Tokorozawa, Saitama, 359-8513, Japan
Nagahama City Hospital
Nagahama, Shiga, 526-8580, Japan
Otsu Municipal Hospital
Ōtsu, Shiga, 520-0804, Japan
Shimane Prefectural Central Hospital
Izumo-shi, Shimane, 693-0068, Japan
Fujieda Municipal General Hospital
Fujieda, Shizuoka, 426-8677, Japan
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, 431-3192, Japan
Shizuoka City Hospital
Shizuoka, Shizuoka, 420 -8630, Japan
Shizuoka Municipal Shimizu Hospital
Shizuoka, Shizuoka, 424-0911, Japan
Yaizu Municipal Hospital
Yaizu, Shizuoka, 425-8505, Japan
Jichi Medical School
Shimotsuke-shi, Tochigi, 329-0498, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, 320-0834, Japan
Anan Kyoei Hospital
Anan, Tokushima, 770-8503, Japan
St. Luke's International Hospital
Chuo-ku, Tokyo, 104-8560, Japan
Tokyo Metropolitan Fuchu Hospital
Fuchū, Tokyo, 183-8524, Japan
Shouwa General Hospital
Kodaira, Tokyo, 187-0004, Japan
Daisan Hospital
Komae, Tokyo, 201, Japan
Kyorin University School of Medicine - Mitaka Campus
Mitaka, Tokyo, 181-8611, Japan
Social Insurance Chuo General Hospital
Shinjuku-ku, Tokyo, 169-0073, Japan
Tokyo Women's Medical University
Shinjyuku-ku, Tokyo, 162-8666, Japan
Mita Hospital at the International University of Health and Welfare
Tokyo, Tokyo, 108-8329, Japan
Tokyo Medical and Dental University
Tokyo, Tokyo, 113-8510, Japan
Nippon Medical School
Tokyo, Tokyo, 113-8603, Japan
Toho University School of Medicine
Tokyo, Tokyo, 143-8541, Japan
Japanese Red Cross Medical Center
Tokyo, Tokyo, 150-8935, Japan
International Medical Center of Japan
Tokyo, Tokyo, 162-8655, Japan
Teikyo University School of Medicine
Tokyo, Tokyo, 173-8605, Japan
Itabashi Chuo Medical Center
Tokyo, Tokyo, 174-8691, Japan
Takasago Kyoritsu Hospital
Tokyo, Tokyo, Japan
Tottori University - Faculty of Medicine
Yonago, Tottori, 683-8503, Japan
Koseiren Takaoka Hospital
Takaoka-shi, Toyama, 933-8555, Japan
Social Insurance Kinan Hospital
Tanabe, Wakayama, 646-8588, Japan
Yamagata Prefectural Central Hospital
Yamagata, Yamagata, 990-2292, Japan
Yamagata University Hospital
Yamagata, Yamagata, 990-9585, Japan
National Hospital Organization - Kanmon Medical Center
Shimonoseki, Yamaguchi, 240-8555, Japan
Shimonoseki Kosei Hospital
Shimonoseki, Yamaguchi, 750-0061, Japan
Yamaguchi University Graduate School of Medicine
Ube, Yamaguchi, 755-8505, Japan
University of Yamanashi Faculty of Medicine
Chu-o-shi, Yamanashi, 409-3898, Japan
Osaka Red Cross Hospital
Osaka, 543-8555, Japan
Biospecimen
Tumor tissue samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kenichi Sugihara, MD, PhD
Tokyo Medical and Dental University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2009
First Posted
May 12, 2009
Study Start
October 1, 2006
Primary Completion
October 1, 2015
Study Completion
September 1, 2016
Last Updated
September 28, 2016
Record last verified: 2016-09