Clinical trial NCT00898846: Identifying Prognostic Factors in Patients Receiving Tegafur-Uracil for Stage II Colon Cancer That Was Completely Removed By Surgery
Official title: Identification of the Prognostic Factors of Stage II Colon Cancer Patients Receiving Adjuvant Chemotherapy With UFT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: stage II colon cancer
stage II rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Tokyo Medical and Dental University
First posted: 2009-05-12
Enrollment: 1111
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with curatively resected stage II colon cancer in 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the colon or rectosigmoid

  * Stage II disease
* Must be registered on clinical trial TMDU-BRI-CC-05-01
* Must have resected tumor tissue available
* No hereditary colorectal cancer

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: mRNA levels
timeFrame: 9years
Secondary outcomes:
measure: Analysis of microsatellite instability (MSI) and chromosomal instability (CIN)
timeFrame: At enrollment
measure: Histopathological examination
timeFrame: At enrollment
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya Ekisaikai Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Ban Buntane Houtokukai Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University School of Medicine
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya Midori Municipal Hospital
state: Aichi
city: Okazaki
country: Japan
facility: Aichi Prefectural Hospital
state: Aichi
city: Noshiro
country: Japan
facility: Yamamoto Kumiai General Hospital
state: Akita
city: Yokote
country: Japan
facility: Hiraka General Hospital
state: Akita
city: Ichihara
country: Japan
facility: Teikyo University Chiba Medical Center
state: Chiba
city: Inba-gunn
country: Japan
facility: Asahi General Hospital
state: Chiba
city: Fukui-shi
country: Japan
facility: Fukuiken Saiseikai Hospital
state: Fukui
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Kitakyushu Municipal Medical Center
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University School of Medicine
state: Fukuoka
city: Kurume
country: Japan
facility: Saint Mary's Hospital
state: Fukuoka
city: Tagawa
country: Japan
facility: Social Insurance Tagawa Hospital
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital
state: Fukushima
city: Gifu-shi
country: Japan
facility: Gifu Municipal Hospital
state: Gifu
city: Hashima
country: Japan
facility: Hashima City Hospital
state: Gifu
city: Ogaki-shi
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Maebashi-shi
country: Japan
facility: Gunma University Graduate School of Medicine
state: Gunma
city: Otashi
country: Japan
facility: Gunma Cancer Center
state: Gunma
city: Fukuyama
country: Japan
facility: National Hospital Organization Fukuyama Medical Center
state: Hiroshima
city: Fukuyama
country: Japan
facility: Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers
state: Hiroshima
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center
state: Hiroshima
city: Miyoshi
country: Japan
facility: Miyoshi Central Hospital
state: Hiroshima
city: Asahikawa
country: Japan
facility: Asahikawa Medical College
state: Hokkaido
city: Asahikawa
country: Japan
facility: Otaru Ekisaikai Hospital
state: Hokkaido
city: Hakodate
country: Japan
facility: Hakodate Goryoukaku Hospital
state: Hokkaido
city: Otaru-shi
country: Japan
facility: Hirosaki University, School of Medicine
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Medical University
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo City General Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Graduate School of Medicine
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Akou
country: Japan
facility: Ako City Hospital
state: Hyogo
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki Hospital
state: Hyogo
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Himeji
country: Japan
facility: Himeji St. Mary's Hospital
state: Hyogo
city: Himeji
country: Japan
facility: Himeji Central Hospital
state: Hyogo
city: Kakogawa
country: Japan
facility: Kakogawa Municipal Hospital
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe City General Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Nishi-Kobe Medical Center
state: Hyogo
city: Kobe
country: Japan
facility: Kobe West City Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe Medical Center
state: Hyogo
city: Kobe
country: Japan
facility: Sano Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Sumoto
country: Japan
facility: Hyogo Prefectural Awaji Hospital
state: Hyogo
city: Takarazukai
country: Japan
facility: Higashi Takarazuka Satoh Hospital
state: Hyogo
city: Takarazuka
country: Japan
facility: Takarazuka Municipal Hospital
state: Hyogo
city: Miki
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
state: Kagawa
city: Ashigarakami-gun
country: Japan
facility: Kanagawa Prefectural Ashigawa-kami Hospital
state: Kanagawa
city: Chigasaki, 253-0083
country: Japan
facility: Chigasaki Municipal Hospital
state: Kanagawa
city: Kawasaki
country: Japan
facility: Kanto Rosai Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Yokohama
country: Japan
facility: International Goodwill Hospital
state: Kanagawa
city: Nankoku
country: Japan
facility: Kochi Medical School
state: Kochi
city: Uki
country: Japan
facility: National Hospital Organization - Kumamotominami Hospital
state: Kumamoto
city: Yatsushiro
country: Japan
facility: Yatsushiro Health Insurance General Hospital
state: Kumamoto
city: Kanigyou-ku
country: Japan
facility: Kyoto Second Red Cross Hospital
state: Kyoto
city: Thu-shi
country: Japan
facility: Mie University Graduate School of Medicine
state: Mie
city: Natori-shi
country: Japan
facility: Miyagi Cancer Center
state: Miyagi
city: Sendai
country: Japan
facility: Tohoku Rosai Hospital
state: Miyagi
city: Iida
country: Japan
facility: Iida Municipal Hospital
state: Nagano
city: Komagane
country: Japan
facility: Showa-Inan General Hospital
state: Nagano
city: Matsumoto
country: Japan
facility: Aizawa Hospital
state: Nagano
city: Nagano-shi
country: Japan
facility: Nagano Municipal Hospital
state: Nagano
city: Nakano
country: Japan
facility: Hokushin Hospital
state: Nagano
city: Yamatotakada
country: Japan
facility: Kenseikai Nara Coloproctology Center
state: Nara
city: Niigata-shi
country: Japan
facility: Niigata University Medical and Dental Hospital
state: Niigata
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Yufu-shi
country: Japan
facility: Oita University Hospital
state: Oita
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Hirakata
country: Japan
facility: Hoshigaoka Koseinenkin Hospital
state: Osaka
city: Izumisano
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Mino
country: Japan
facility: Minoh City Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Police Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Kosei Nenkin Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka General Medical Center
state: Osaka
city: Sakai-shi
country: Japan
facility: Osaka Rosai Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: Suita Municipal Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical College
state: Osaka
city: Tondabayashi
country: Japan
facility: Saiseikai Tondabayashi Hospital
state: Osaka
city: Fukaya
country: Japan
facility: Fukaya Red Cross Hospital
state: Saitama
city: Hasuda
country: Japan
facility: Hasuda Hospital
state: Saitama
city: Kawagoe-shi
country: Japan
facility: Saitama Medical School Hospital
state: Saitama
city: Tokorozawa
country: Japan
facility: National Defense Medical College
state: Saitama
city: Nagahama
country: Japan
facility: Nagahama City Hospital
state: Shiga
city: Otsu
country: Japan
facility: Otsu Municipal Hospital
state: Shiga
city: Izumo-shi
country: Japan
facility: Shimane Prefectural Central Hospital
state: Shimane
city: Fujieda
country: Japan
facility: Fujieda Municipal General Hospital
state: Shizuoka
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
city: Yaizu
country: Japan
facility: Yaizu Municipal Hospital
state: Shizuoka
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical School
state: Tochigi
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Anan
country: Japan
facility: Anan Kyoei Hospital
state: Tokushima
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Fuchu
country: Japan
facility: Tokyo Metropolitan Fuchu Hospital
state: Tokyo
city: Kodaira
country: Japan
facility: Shouwa General Hospital
state: Tokyo
city: Komae
country: Japan
facility: Daisan Hospital
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University School of Medicine - Mitaka Campus
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Social Insurance Chuo General Hospital
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Tokyo Women's Medical University
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University - Faculty of Medicine
state: Tottori
city: Takaoka-shi
country: Japan
facility: Koseiren Takaoka Hospital
state: Toyama
city: Tanabe
country: Japan
facility: Social Insurance Kinan Hospital
state: Wakayama
city: Shimonoseki
country: Japan
facility: National Hospital Organization - Kanmon Medical Center
state: Yamaguchi
city: Shimonoseki
country: Japan
facility: Shimonoseki Kosei Hospital
state: Yamaguchi
city: Ube
country: Japan
facility: Yamaguchi University Graduate School of Medicine
state: Yamaguchi
city: Chu-o-shi
country: Japan
facility: University of Yamanashi Faculty of Medicine
state: Yamanashi
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Gifu
country: Japan
facility: Matsunami General Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Ibaraki
country: Japan
facility: National Hospital Organization Mito Medical Center
city: Kagoshima
country: Japan
facility: Nanpuh Hospital
city: Kanagawa
country: Japan
facility: Kitasato University School of Medicine
city: Kumamoto
country: Japan
facility: Kumamoto University Faculty of Medical and Pharmaceutical Sciences
city: Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Kyoto
country: Japan
facility: Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Nishijin Hospital
city: Nagano
country: Japan
facility: Nagano Red Cross Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nara
country: Japan
facility: Saiseikai Nara Hospital
city: Niigata
country: Japan
facility: Saiseikai Niigata Daini Hospital
city: Okayama
country: Japan
facility: Okayama University Medical School
city: Osaka
country: Japan
facility: Kitano Hospital
city: Osaka
country: Japan
facility: Osaka City Juso Hospital
city: Osaka
country: Japan
facility: Otemae Hospital
city: Osaka
country: Japan
facility: Osaka Red Cross Hospital
city: Osaka
country: Japan
facility: Higashi Sumiyoshi Morimoto Hospital
city: Osaka
country: Japan
facility: Nissay Hospital
city: Osaka
country: Japan
facility: Osaka Saiseikai Noe Hospital
city: Osaka
country: Japan
facility: Minamiosaka Hospital
city: Saitama
country: Japan
facility: Saitama Social Insurance Hospital
city: Shizuoka
country: Japan
facility: Shizuoka City Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Municipal Shimizu Hospital
city: Tokyo
country: Japan
facility: Mita Hospital at the International University of Health and Welfare
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University
city: Tokyo
country: Japan
facility: Nippon Medical School
city: Tokyo
country: Japan
facility: Toho University School of Medicine
city: Tokyo
country: Japan
facility: Japanese Red Cross Medical Center
city: Tokyo
country: Japan
facility: International Medical Center of Japan
city: Tokyo
country: Japan
facility: Teikyo University School of Medicine
city: Tokyo
country: Japan
facility: Itabashi Chuo Medical Center
city: Tokyo
country: Japan
facility: Takasago Kyoritsu Hospital
city: Yamagata
country: Japan
facility: Yamagata Prefectural Central Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
Study officials:
affiliation: Tokyo Medical and Dental University
name: Kenichi Sugihara, MD, PhD
role: STUDY_CHAIR
References: