Identifying Prognostic Factors in Patients Receiving Tegafur-Uracil for Stage II Colon Cancer That Was Completely Removed By Surgery

Colorectal Cancer Clinical Trial

Official title:

Identification of the Prognostic Factors of Stage II Colon Cancer Patients Receiving Adjuvant Chemotherapy With UFT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898846
• Other study ID #: CDR0000551714
• Secondary ID: TMDU-BRI-CC-05-0
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: September 26, 2016
• Start date: October 2006
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan : Translational Research Informatics Center Ethical Committiee
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1111
• Est. completion date: September 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	Tokyo Medical and Dental University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Analysis of microsatellite instability (MSI) and chromosomal instability (CIN)	MSI and CIN (i.e., 18q LOH) are analyzed using paraffin embedded samples.	At enrollment	No
Secondary	Histopathological examination	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.	At enrollment	No