Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery

Colorectal Cancer Clinical Trial

Official title:

Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392899
• Other study ID #: CDR0000512573
• Secondary ID: TMDU-BRI-CC-05-0
• Status: Completed
• Phase: Phase 3
• First received: October 25, 2006
• Last updated: September 26, 2016
• Start date: October 2006
• Est. completion date: September 2016

Study information

• Verified date: July 2009
• 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: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating colorectal cancer.

PURPOSE: This randomized phase III trial is studying tegafur and uracil to see how well they work compared to observation in treating patients with stage II colorectal cancer that has been completely removed by surgery.

Description:

OBJECTIVES:

Primary

• Compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with curatively resected stage II colorectal cancer.

Secondary

• Compare relapse-free and overall survival of patients treated with these regimens.

• Compare the occurrence of adverse events in patients treated with these regimens.

OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo observation.

• Arm II: Patients receive oral tegafur-uracil on days 1-5. Treatment repeats every 7 days for 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2025
• 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

• Has undergone curative (R0) resection within the past 8 weeks

• No suspicion of hereditary colorectal cancer

• No severe postoperative complications

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• WBC 3,500-12,000/mm³

• Absolute neutrophil count = 1,500/mm³

• Platelet count = 100,000/mm³

• Hemoglobin = 9.0 g/dL

• Bilirubin = 2.0 mg/dL

• AST and ALT = 100 IU/L

• Creatinine = 1.5 mg/dL

• Not pregnant or nursing

• Able to take oral medications

• Major organ functions are preserved

• No other active malignancy

• None of the following conditions:

• Uncontrolled diabetes mellitus

• Uncontrolled hypertension

• Myocardial infarction or unstable angina pectoris within the past 6 months

• Liver cirrhosis

• Interstitial pneumonia

• Pulmonary fibrosis

• Severe emphysema

• No psychiatric disease or other condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy

• No prior or concurrent radiotherapy

• No concurrent prophylactic growth factors

• No concurrent biologic response modifiers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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	Ageo Central General Hospital	Ageo
Japan	Aichi Medical University	Aichi-gun	Aichi
Japan	Akashi Municipal Hospital	Akashi	Hyogo
Japan	Hyogo Cancer Center	Akashi	Hyogo
Japan	Saiseikai Hiroshima Hospital	Aki-Gun
Japan	Akita Kumiai General Hospital	Akita
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	Aomori City Hospital	Aomori
Japan	Asahi General Hospital	Asahi-machi	Chiba
Japan	Asahikawa Medical College	Asahikawa	Hokkaido
Japan	Otaru Ekisaikai Hospital	Asahikawa	Hokkaido
Japan	Kanagawa Prefectural Ashigawa-kami Hospital	Ashigarakami-gun	Kanagawa
Japan	Juntendo University School of Medicine	Bunkyo-ku	Tokyo
Japan	Chiba Cancer Center	Chiba
Japan	Chiba University	Chiba
Japan	Chigasaki Municipal Hospital	Chigasaki	Kanagawa
Japan	University of Yamanashi Faculty of Medicine	Chu-o-shi	Yamanashi
Japan	St. Luke's International Hospital	Chuo-ku	Tokyo
Japan	Northern Fukushima Medical Center	Date
Japan	Tokyo Metropolitan Fuchu Hospital	Fuchu	Tokyo
Japan	Fujieda Municipal General Hospital	Fujieda	Shizuoka
Japan	Fujisawa City Hospital	Fujisawa-shi	Kanagawa
Japan	Fukaya Red Cross Hospital	Fukaya	Saitama
Japan	Fukuiken Saiseikai Hospital	Fukui-shi	Fukui
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	National Kyushu Cancer 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	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Kyoto First Red Cross Hospital	Higashiyama-ku	Kyoto
Japan	Higashiyamato General Hospital	Higashiyamato	Tokyo
Japan	Himeji Central Hospital	Himeji	Hyogo
Japan	Himeji St. Mary's Hospital	Himeji	Hyogo
Japan	Hoshigaoka Koseinenkin Hospital	Hirakata	Osaka
Japan	Hiroshima Prefectural Hospital	Hiroshima
Japan	Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital	Hiroshima
Japan	Hiroshima University Hospital	Hiroshima
Japan	Chugoku Electric Power Hospital	Hiroshima-shi
Japan	National Hospital Organization Mito Medical Center	Ibaraki
Japan	Teikyo University Chiba Medical Center	Ichihara	Chiba
Japan	Iida Municipal Hospital	Iida	Nagano
Japan	Kinki Central Hospital	Itami	Hyogo
Japan	Hokkaido Chuo Rosai Hospital	Iwamizawa
Japan	Izumiotsu Municipal Hospital	Izumiotsu	Osaka
Japan	Rinku General Medical Center	Izumisano	Osaka
Japan	Shimane Prefectural Central Hospital	Izumo-shi	Shimane
Japan	Nanpuh Hospital	Kagoshima
Japan	Kanazawa Medical University	Kahoku-gun	Ishikawa
Japan	Kakogawa Municipal Hospital	Kakogawa	Hyogo
Japan	Kitasato University School of Medicine	Kanagawa
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	Kyoto Second Red Cross Hospital	Kanigyou-ku	Kyoto
Japan	Nara Medical University Cancer Center	Kashihara	Nara
Japan	Osaka Minami Medical Center	Kawachinagano
Japan	Saitama Medical School Hospital	Kawagoe-shi	Saitama
Japan	Kanto Rosai Hospital	Kawasaki	Kanagawa
Japan	Nippon Medical School Musashikosugi Hospital	Kawasaki	Kanagawa
Japan	Saint Marianna University School of Medicine	Kawasaki	Kanagawa
Japan	Kiryu Kosei General Hospital	Kiryu
Japan	Tokyo-Kita Social Insurance Hospital	Kita-ku	Tokyo
Japan	Kitakyushu Municipal Medical Center	Kitakyushu	Fukuoka
Japan	University of Occupational and Environmental Health	Kitakyushu-shi	Fukuoka
Japan	Kitasato Institute Medical Center Hospital	Kitamoto	Saitama
Japan	Kobe Ekisaikai Hospital	Kobe
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	Shakai Hoken Kobe Central Hospital	Kobe	Hyogo
Japan	Kobe City General Hospital	Kobe-shi	Hyogo
Japan	Kochi Health Sciences Center	Kochi
Japan	Showa General Hospital	Kodaira	Tokyo
Japan	Daisan Hospital	Komae	Tokyo
Japan	Showa-Inan General Hospital	Komagane	Nagano
Japan	Konan Kosei Hospital	Konan
Japan	Southern TOHOKU research Institute for Neuroscience	Koriyama-city
Japan	Japanese Red Cross Kumamoto Hospital	Kumamoto
Japan	Kumamoto University Faculty of Medical and Pharmaceutical Sciences	Kumamoto
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
Japan	Kawasaki Medical School	Kurashiki-shi	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	Kyoto-Katsura Hospital	Kyoto
Japan	National Hospital Organization - Kyoto Medical Center	Kyoto
Japan	Nishijin Hospital	Kyoto
Japan	Gunma University Graduate School of Medicine	Maebashi-shi	Gunma
Japan	Nagasaki University Hospital	Magasaki-shi	Nagasaki
Japan	Kagawa Rosai Hospital	Marugame	Kagawa
Japan	Aizawa Hospital	Matsumoto	Nagano
Japan	Saiseikai Matsusaka General Hospital	Matsusaka
Japan	Shikoku Cancer Center	Matsuyama	Ehime
Japan	Toho University Ohashi Hospital	Meguro-ku	Tokyo
Japan	Kagawa University Hospital	Miki	Kagawa
Japan	Toranomon Hospital	Minato-ku	Tokyo
Japan	Minoh City Hospital	Mino	Osaka
Japan	Kyorin University School of Medicine - Mitaka Campus	Mitaka	Tokyo
Japan	Mito Saiseikai General Hospital	Mito	Ibaraki
Japan	Miyoshi Central Hospital	Miyoshi	Hiroshima
Japan	Kansai Medical University Takii Hospital	Moriguchi	Osaka
Japan	Iwate Medical University Hospital	Morioka	Iwate
Japan	Iwate Prefectural Central Hospital	Morioka	Iwate
Japan	Muroran City General Hospital	Muroran
Japan	Nagano Municipal Hospital	Nagano-shi	Nagano
Japan	Nagaoka Chuo General Hospital	Nagaoka	Niigata
Japan	Japanese Red Cross Nagasaki Genbaku Hospital	Nagasaki-shi	Nagasaki
Japan	Aichi Cancer Center	Nagoya	Aichi
Japan	Ban Buntane Houtokukai Hospital	Nagoya	Aichi
Japan	Kyoritsu General Hospital	Nagoya
Japan	Nagoya Central 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	West Medical Center Jouhoku Municipal Hospital	Nagoya	Aichi
Japan	Japanese Red Cross Nagoya First Hospital	Nagoya-shi	Aichi
Japan	Nagoya City University Hospital	Nagoya-shi	Aichi
Japan	Hokushin Hospital	Nakano	Nagano
Japan	Nakano General Hospital	Nakano	Tokyo
Japan	Nakatsu Municipal Hospital	Nakatsu
Japan	Kochi Medical School	Nankoku	Kochi
Japan	Nantan General Hospital	Nantan	Kyoto
Japan	Nara Prefectual Nara Hospital	Nara
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	Sumitomo Besshi Hospital	Niihama	Ehime
Japan	Hyogo College of Medicine	Nishinomiya	Hyogo
Japan	Yamamoto Kumiai General Hospital	Noshiro	Akita
Japan	Numazu City Hospital	Numazu, Shizuoka
Japan	Ogaki Municipal Hospital	Ogaki-shi	Gifu
Japan	Ohtawara Red Cross Hospital	Ohtawawa	Tochigi
Japan	Almeida Memorial Hospital	Oita
Japan	Oita Red Cross Hospital	Oita
Japan	Oita Prefectural Hospital	Oita-shi
Japan	Okayama University Medical School	Okayama
Japan	Aichi Cancer Center at Aichi Hospital	Okazaki	Aichi
Japan	Nakagami Hospital	Okinawa
Japan	National Hospital Organization Nagasaki Medical Center	Omura	Nagasaki
Japan	Higashi Sumiyoshi Morimoto Hospital	Osaka
Japan	Kitano Hospital	Osaka
Japan	Minamiosaka Hospital	Osaka
Japan	Nissay Hospital	Osaka
Japan	NTT West Osaka 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	Yodogawa Christian 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	Kinki University School of Medicine	Osakasayama	Osaka
Japan	Hirosaki University, School of Medicine	Otaru-shi	Hokkaido
Japan	Gunma Cancer Center	Otashi	Gunma
Japan	Otsu Municipal Hospital	Otsu	Shiga
Japan	Shiga University of Medical Science	Otsu-shi	Shiga
Japan	Saga Prefectural Hospital Koseikan	Saga
Japan	Sagamihara National Hospital	Sagamihara	Kanagawa
Japan	Saitama Social Insurance Hospital	Saitama
Japan	Omiya Medical Center ofJichi Medical School	Saitamaken	Saitama
Japan	Bell Land General Hospital	Sakai	Osaka
Japan	Sakai Municipal Hospital	Sakai	Osaka
Japan	Osaka Rosai Hospital	Sakai-shi	Osaka
Japan	Kyoto University Hospital	Sakyo-ku	Kyoto
Japan	Hokkaido University Graduate School of Medicine	Sapporo	Hokkaido
Japan	Sapporo City General Hospital	Sapporo	Hokkaido
Japan	Sapporo Medical University	Sapporo	Hokkaido
Japan	Sapporo-Kosei General Hospital	Sapporo-shi	Hokkaido
Japan	Sasebo City General Hospital	Sasebo-shi	Nagasaki
Japan	Hakodate Municipal Hospital	Sendai
Japan	Japanese Red Cross Sendai Hospital	Sendai
Japan	Miyagi Social Insurance Hospital	Sendai
Japan	Sendai Kousei Hospital	Sendai	Miyagi
Japan	Sendai Medical Center	Sendai	Miyagi
Japan	Tohoku Rosai Hospital	Sendai	Miyagi
Japan	Tohoku University Graduate School of Medicine	Sendai	Miyagi
Japan	National Hospital Organization - Kanmon Medical Center	Shimonoseki	Yamaguchi
Japan	Shimonoseki Kosei Hospital	Shimonoseki	Yamaguchi
Japan	Dokkyo University School of Medicine	Shimotsuga-gun	Tochigi
Japan	Jichi Medical School	Shimotsuke-shi	Tochigi
Japan	Shingu Municipal Medical Center	Shingu	Wakayama
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	Kawakita General Hospital	Suginami-ku
Japan	Suita Municipal Hospital	Suita-shi	Osaka
Japan	Hyogo Prefectural Awaji Hospital	Sumoto	Hyogo
Japan	Shizuoka Cancer Center	Sunto-gun	Shizuoka
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	Niigata Prefectural Tokamachi Hospital	Tokamachi
Japan	National Defense Medical College	Tokorozawa	Saitama
Japan	National Hospital Organization - Nishisaitama-Chuo National Hospital	Tokorozawa	Saitama
Japan	Tokushima University Hospital	Tokushima
Japan	International Medical Center of Japan	Tokyo
Japan	Japanese Red Cross Medical Center	Tokyo
Japan	Jikei University School of Medicine Hospital	Tokyo
Japan	Metropolitan Bokutoh Hospital	Tokyo
Japan	Mita Hospital at the International University of Health and Welfare	Tokyo
Japan	National Hospital Organization - Tokyo Medical Center	Tokyo
Japan	Nippon Medical School	Tokyo
Japan	NTT Kanto Medical Center	Tokyo
Japan	Showa University Toyosu Hospital	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	Tokyo Metropolitan - Komagome Hospital	Tokyo
Japan	Tokyo Women's Medical University Medical Center East	Tokyo
Japan	Saiseikai Tondabayashi Hospital	Tondabayashi	Osaka
Japan	Toyama Red Cross Hospital	Toyama
Japan	Toyama Prefectural Central Hospital	Toyama-shi	Toyama
Japan	National Hospital Organization Toyohashi Medical Center	Toyohashi	Aichi
Japan	Toyohashi Municipal Hospital	Toyohashi	Aichi
Japan	Koseiren Kamo Hospital	Toyota	Aichi
Japan	Tsuchiura Kyodo General Hospital	Tsuchiura	Ibaraki
Japan	Yamaguchi University Graduate School of Medicine	Ube	Yamaguchi
Japan	National Hospital Organization - Kumamotominami Hospital	Uki	Kumamoto
Japan	Juntendo Urayasu Hospital	Urayasu-shi	Chiba
Japan	Tochigi Cancer Center	Utsunomiya	Tochigi
Japan	Japan Labor Health and Welfare Organization Wakayama Rosai Hospital	Wakayama
Japan	Japanese Red Cross Society	Wakayama
Japan	Wakayama Medical University	Wakayama-shi	Wakayama
Japan	Yaizu Municipal Hospital	Yaizu	Shizuoka
Japan	Yamagata Prefectural Central Hospital	Yamagata
Japan	Yamagata Saisei Hospital	Yamagata
Japan	Yamagata University Hospital	Yamagata
Japan	Kenseikai Nara Coloproctology Center	Yamatotakada	Nara
Japan	Public Shiso General Hospital	Yamsakicho	Hyogo
Japan	Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital	Yashiro	Kumamoto
Japan	Yatsushiro Health Insurance General Hospital	Yatsushiro	Kumamoto
Japan	Hitachi Yokohama Hospital	Yokohama
Japan	International Goodwill Hospital	Yokohama	Kanagawa
Japan	Kanagawa Cancer Center	Yokohama	Kanagawa
Japan	Saiseikai Yokohama City Nanbu Hospital	Yokohama	Kanagawa
Japan	Saiseikai Yokohamashi Tobu Hospital	Yokohama
Japan	Showa University Fujigaoka Hospital	Yokohama	Kanagawa
Japan	Social Insurance Yokohama Central Hospital	Yokohama	Kanagawa
Japan	St. Marianna University Yokohama City Seibu Hospital	Yokohama	Kanagawa
Japan	Yokohama City Hospital	Yokohama	Kanagawa
Japan	Yokohama City Minato Red Cross Hospital	Yokohama
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa
Japan	Showa University Northern Yokohama Hospital	Yokohama-shi	Kanagawa
Japan	Yokosuka Kyosai Hospital	Yokosuka	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	Disease-free survival	Disease-free survival is defined as the time from date of enrollement until date of recurrence, other malignancies or death from any cause, whichever comes first.	9 years	No
Secondary	Overall survival	Overall survival is defined as time from date of enrollment until date of death from any cause.	9 years	No
Secondary	Types and severities of adverse events	Types and severities of adverse events from date of starting protocol treatment until 30 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.	15 months	Yes