AzTrials
AzTrials

Colorectal CancerPhase 3NCT00392899

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

A Phase 3 study testing UFT adjuvant chemotherapy in people with Colorectal Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 272 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Colorectal Cancer
What is being tested?
UFT adjuvant chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,025 participants
Where
272 sitesJapan
Study dates
Oct 2006to Sep 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

272 sites in 1 country.

272 sites in 1 country

Japan272 sites

  • Ageo Central General Hospital

    Ageo, 362-8588

  • Aichi Medical University

    Aichi-gun, Aichi-ken, 480-1100

  • Akashi Municipal Hospital

    Akashi, Hyōgo, 673-8501

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

  • Saiseikai Hiroshima Hospital

    Aki-Gun, 731-4311

  • Akita Kumiai General Hospital

    Akita, Akita, 011-0948

  • Ako City Hospital

    Akou, Hyōgo, 678-0232

  • Hyogo Prefectural Amagasaki Hospital

    Amagasaki, Hyōgo, 660-0828

  • Kansai Rosai Hospital

    Amagasaki, Hyōgo, 660-8511

  • Anan Kyoei Hospital

    Anan, Tokushima, 770-8503

  • Aomori City Hospital

    Aomori, Aomori, 030-0821

  • Asahi General Hospital

    Asahi-machi, Chiba, 289-2511

  • Asahikawa Medical College

    Asahikawa, Hokkaido, 078-8510

  • Otaru Ekisaikai Hospital

    Asahikawa, Hokkaido, 078-8510

  • Kanagawa Prefectural Ashigawa-kami Hospital

    Ashigarakami-gun, Kanagawa, 258-0003

  • Juntendo University School of Medicine

    Bunkyo-ku, Tokyo, 113-0033

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

  • Chiba University

    Chiba, Chiba, 260

  • Chigasaki Municipal Hospital

    Chigasaki, Kanagawa, 253-0083

  • University of Yamanashi Faculty of Medicine

    Chu-o-shi, Yamanashi, 409-3898

  • St. Luke's International Hospital

    Chuo-ku, Tokyo, 104-8560

  • Northern Fukushima Medical Center

    Date, 960-0502

  • Tokyo Metropolitan Fuchu Hospital

    Fuchū, Tokyo, 183-8524

  • Fujieda Municipal General Hospital

    Fujieda, Shizuoka, 426-8677

  • Fujisawa City Hospital

    Fujisawa-shi, Kanagawa, 251-8550

  • Fukaya Red Cross Hospital

    Fukaya, Saitama, 366-0052

  • Fukuiken Saiseikai Hospital

    Fukui-shi, Fukui, 918-8503

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-0065

  • National Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • National Hospital Organization Fukuyama Medical Center

    Fukuyama, Hiroshima, 720-0825

  • Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers

    Fukuyama, Hiroshima, 721-8581

  • Gifu Municipal Hospital

    Gifu, Gifu, 500-8323

  • Matsunami General Hospital

    Gifu, Gifu, 501-6062

  • Hakodate Goryoukaku Hospital

    Hakodate, Hokkaido, 040-8611

  • Hamamatsu University School of Medicine

    Hamamatsu, Shizuoka, 431-3192

  • Hashima City Hospital

    Hashima, Gifu, 501-6206

  • Hasuda Hospital

    Hasuda, Saitama, 349-0123

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 350-1241

  • Kyoto First Red Cross Hospital

    Higashiyama-ku, Kyoto, 605-0981

  • Higashiyamato General Hospital

    Higashiyamato, Tokyo, 207-0014

  • Himeji St. Mary's Hospital

    Himeji, Hyōgo, 670-0801

  • Himeji Central Hospital

    Himeji, Hyōgo, 672-8501

  • Kagawa University Hospital

    Hiragi, Kagawa-ken, 761-0793

  • Hoshigaoka Koseinenkin Hospital

    Hirakata, Osaka, 573-8511

  • Hiroshima Prefectural Hospital

    Hiroshima, Hiroshima, 734-8530

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Chugoku Electric Power Hospital

    Hiroshima, 730-8562

  • Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital

    Hiroshima, 730-8619

  • National Hospital Organization Mito Medical Center

    Ibaraki, Ibaraki, 311-3193

  • Teikyo University Chiba Medical Center

    Ichihara, Chiba, 299-0111

  • Iida Municipal Hospital

    Iida, Nagano, 395-8502

  • Kinki Central Hospital

    Itami, Hyōgo

  • Hokkaido Chuo Rosai Hospital

    Iwamizawa, 068-0004

  • Izumiotsu Municipal Hospital

    Izumiōtsu, Osaka, 595

  • Rinku General Medical Center

    Izumisano, Osaka, 598-8577

  • Shimane Prefectural Central Hospital

    Izumo-shi, Shimane, 693-0068

  • Nanpuh Hospital

    Kagoshima, Kagoshima-ken, 892-8512

  • Kanazawa Medical University

    Kahoku-gun, Ishikawa-ken, 920-0265

  • Kakogawa Municipal Hospital

    Kakogawa, Hyōgo, 675-8611

  • Kitasato University School of Medicine

    Kanagawa, Kanagawa, 228-8555

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Kyoto Second Red Cross Hospital

    Kanigyou-ku, Kyoto, 602-8026

  • Nara Medical University Cancer Center

    Kashihara, Nara, 634-8522

  • Osaka Minami Medical Center

    Kawachi-Nagano, 586-8521

  • Saitama Medical School Hospital

    Kawagoe-shi, Saitama, 350-8550

  • Kanto Rosai Hospital

    Kawasaki, Kanagawa, 211-8510

  • Nippon Medical School Musashikosugi Hospital

    Kawasaki, Kanagawa, 211-8533

  • Saint Marianna University School of Medicine

    Kawasaki, Kanagawa, 216-8511

  • Kiryu Kosei General Hospital

    Kiryū, 376-0024

  • Tokyo-Kita Social Insurance Hospital

    Kita-ku, Tokyo, 115-0053

  • Kitakyushu Municipal Medical Center

    Kitakyushu, Fukuoka, 802-0077

  • University of Occupational and Environmental Health

    Kitakyushu-shi, Fukuoka, 807-8555

  • Kitasato Institute Medical Center Hospital

    Kitamoto, Saitama, 3648501

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • Kobe City General Hospital

    Kobe, Hyōgo, 650-0046

  • Shakai Hoken Kobe Central Hospital

    Kobe, Hyōgo, 651-1145

  • Nishi-Kobe Medical Center

    Kobe, Hyōgo, 651-2273

  • Kobe West City Hospital

    Kobe, Hyōgo, 653-0013

  • Kobe Medical Center

    Kobe, Hyōgo, 654-0155

  • Sano Hospital

    Kobe, Hyōgo, 655-0031

  • Kobe Ekisaikai Hospital

    Kobe, 655-0004

  • Kochi Health Sciences Center

    Kochi, Kochi, 781-8555

  • Showa General Hospital

    Kodaira, Tokyo, 187-8510

  • Daisan Hospital

    Komae, Tokyo, 201

  • Showa-Inan General Hospital

    Komagane, Nagano, 399-4191

  • Konan Kosei Hospital

    Kōnan, 483-8704

  • Southern TOHOKU research Institute for Neuroscience

    Kōriyama, 963-8563

  • Kumamoto University Faculty of Medical and Pharmaceutical Sciences

    Kumamoto, Kumamoto, 860-8556

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, Kumamoto, 861-8520

  • Kurashiki Central Hospital

    Kurashiki, Okayama-ken, 710-8602

  • Kawasaki Medical School

    Kurashiki-shi, Okayama-ken, 701-0192

  • National Hospital Organization Kure Medical Center

    Kure, Hiroshima, 737-0023

  • Kurume University School of Medicine

    Kurume, Fukuoka, 830-0011

  • Saint Mary's Hospital

    Kurume, Fukuoka, 830-8543

  • Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-0841

  • Nishijin Hospital

    Kyoto, Kyoto, 602

  • National Hospital Organization - Kyoto Medical Center

    Kyoto, Kyoto, 612-0861

  • Kyoto-Katsura Hospital

    Kyoto, Kyoto, 615-8256

  • Gunma University Graduate School of Medicine

    Maebashi, Gunma, 371-8511

  • Nagasaki University Hospital

    Magasaki-shi, Nagasaki, 852-8501

  • Kagawa Rosai Hospital

    Marugame, Kagawa-ken, 763-8502

  • Aizawa Hospital

    Matsumoto, Nagano, 390-8510

  • Saiseikai Matsusaka General Hospital

    Matsusaka, 515-0004

  • Shikoku Cancer Center

    Matsuyama, Ehime, 790-0007

  • Toho University Ohashi Hospital

    Meguro-ku, Tokyo, 153-8515

  • Toranomon Hospital

    Minato-ku, Tokyo, 105-8470

  • Minoh City Hospital

    Mino, Osaka, 562-0014

  • Kyorin University School of Medicine - Mitaka Campus

    Mitaka, Tokyo, 181-8611

  • Mito Saiseikai General Hospital

    Mito, Ibaraki, 311-4198

  • Miyoshi Central Hospital

    Miyoshi, Hiroshima, 728-8502

  • Kansai Medical University Takii Hospital

    Moriguchi, Osaka, 570-8507

  • Iwate Medical University Hospital

    Morioka, Iwate, 020-8505

  • Iwate Prefectural Central Hospital

    Morioka, Iwate, 020-8505

  • Muroran City General Hospital

    Muroran, 051-8512

  • Nagano Municipal Hospital

    Nagano, Nagano, 381-8551

  • Nagaoka Chuo General Hospital

    Nagaoka, Niigata, 940-8653

  • Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, Nagasaki, 852-8511

  • Japanese Red Cross Nagoya First Hospital

    Nagoya, Aichi-ken, 453-0046

  • Nagoya Central Hospital

    Nagoya, Aichi-ken, 453-0801

  • Nagoya Ekisaikai Hospital

    Nagoya, Aichi-ken, 454-8502

  • Ban Buntane Houtokukai Hospital

    Nagoya, Aichi-ken, 454-8509

  • West Medical Center Jouhoku Municipal Hospital

    Nagoya, Aichi-ken, 462-0033

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8550

  • Nagoya University School of Medicine

    Nagoya, Aichi-ken, 466

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Nagoya Midori Municipal Hospital

    Nagoya, Aichi-ken

  • Kyoritsu General Hospital

    Nagoya, 456-8611

  • Hokushin Hospital

    Nakano, Nagano, 383-0021

  • Nakano General Hospital

    Nakano City, Tokyo, 164-8607

  • Nakatsu Municipal Hospital

    Nakatsu, 871-0011

  • Kochi Medical School

    Nankoku, Kochi, 783-8505

  • Nantan General Hospital

    Nantan, Kyoto, 629-0197

  • Saiseikai Nara Hospital

    Nara, Nara, 6308145

  • Nara Prefectual Nara Hospital

    Nara, 631-0846

  • Miyagi Cancer Center

    Natori-shi, Miyagi, 981-1293

  • Saiseikai Niigata Daini Hospital

    Niigata, Niigata, 950-1104

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata, 951-8122

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

  • Sumitomo Besshi Hospital

    Niihama, Ehime, 792-0008

  • Hyogo College of Medicine

    Nishinomiya, Hyōgo, 663-8501

  • Yamamoto Kumiai General Hospital

    Noshiro, Akita, 016-0014

  • Numazu City Hospital

    Numazu, Shizuoka, 410-0302

  • Ogaki Municipal Hospital

    Ogaki-shi, Gifu, 503-8502

  • Ohtawara Red Cross Hospital

    Ohtawawa, Tochigi, 324-0

  • Oita Red Cross Hospital

    Ōita, 870-0033

  • Almeida Memorial Hospital

    Ōita, 870-1195

  • Oita Prefectural Hospital

    Ōita, 870-8511

  • Okayama University Medical School

    Okayama, Okayama-ken, 700-8558

  • Aichi Cancer Center at Aichi Hospital

    Okazaki, Aichi-ken, 444-0011

  • Nakagami Hospital

    Okinawa, Okinawa, 904-2195

  • National Hospital Organization Nagasaki Medical Center

    Ōmura, Nagasaki, 856-8562

  • Kitano Hospital

    Osaka, Osaka, 530-8480

  • Osaka City Juso Hospital

    Osaka, Osaka, 532-0

  • Osaka City General Hospital

    Osaka, Osaka, 534-0021

  • Osaka Saiseikai Noe Hospital

    Osaka, Osaka, 536-0002

  • Otemae Hospital

    Osaka, Osaka, 540-0008

  • Osaka Police Hospital

    Osaka, Osaka, 543-8502

  • Higashi Sumiyoshi Morimoto Hospital

    Osaka, Osaka, 546-0012

  • Nissay Hospital

    Osaka, Osaka, 550-0012

  • Osaka Kosei Nenkin Hospital

    Osaka, Osaka, 553-0003

  • Osaka General Medical Center

    Osaka, Osaka, 558-8558

  • Minamiosaka Hospital

    Osaka, Osaka

  • Yodogawa Christian Hospital

    Osaka, 533-0032

  • Osaka Red Cross Hospital

    Osaka, 543-8555

  • NTT West Osaka Hospital

    Osaka, 543-8922

  • Hirosaki University, School of Medicine

    Otaru-shi, Hokkaido, 047-0031

  • Gunma Cancer Center

    Otashi, Gunma, 373-8550

  • Otsu Municipal Hospital

    Ōtsu, Shiga, 520-0804

  • Shiga University of Medical Science

    Ōtsu, Shiga, 520-2192

  • Saga Prefectural Hospital Koseikan

    Saga, Saga-ken, 840-8571

  • Sagamihara National Hospital

    Sagamihara, Kanagawa, 228-8522

  • Saitama Social Insurance Hospital

    Saitama, Saitama, 330-0074

  • Omiya Medical Center ofJichi Medical School

    Saitamaken, Saitama, 330-8503

  • Sakai Municipal Hospital

    Sakai, Osaka, 590-0064

  • Bell Land General Hospital

    Sakai, Osaka, 599-8247

  • Osaka Rosai Hospital

    Sakai-shi, Osaka, 591-8025

  • Kyoto University Hospital

    Sakyo-ku, Kyoto, 606-8507

  • Sapporo-Kosei General Hospital

    Sapporo, Hokkaido, 060-0033

  • Sapporo Medical University

    Sapporo, Hokkaido, 060-8556

  • Sapporo City General Hospital

    Sapporo, Hokkaido, 060-8604

  • Hokkaido University Graduate School of Medicine

    Sapporo, Hokkaido, 060-8638

  • Sasebo City General Hospital

    Sasebo-shi, Nagasaki, 857-8511

  • Kinki University School of Medicine

    Sayama, Osaka, 589-8511

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873

  • Tohoku University Graduate School of Medicine

    Sendai, Miyagi, 980-8574

  • Tohoku Rosai Hospital

    Sendai, Miyagi, 981-0911

  • Sendai Medical Center

    Sendai, Miyagi, 983-8520

  • Hakodate Municipal Hospital

    Sendai, 981-1103

  • Miyagi Social Insurance Hospital

    Sendai, 981-1103

  • Japanese Red Cross Sendai Hospital

    Sendai, 982-8501

  • National Hospital Organization - Kanmon Medical Center

    Shimonoseki, Yamaguchi, 240-8555

  • Shimonoseki Kosei Hospital

    Shimonoseki, Yamaguchi, 750-0061

  • Dokkyo University School of Medicine

    Shimotsuga-gun, Tochigi, 321-0293

  • Jichi Medical School

    Shimotsuke-shi, Tochigi, 329-0498

  • Shingu Municipal Medical Center

    Shingū, Wakayama, 647-0072

  • Social Insurance Chuo General Hospital

    Shinjuku-ku, Tokyo, 169-0073

  • Tokyo Women's Medical University

    Shinjyuku-ku, Tokyo, 162-8666

  • Shizuoka City Hospital

    Shizuoka, Shizuoka, 420 -8630

  • Shizuoka Municipal Shimizu Hospital

    Shizuoka, Shizuoka, 424-0911

  • Kawakita General Hospital

    Suginami-ku, 166-8588

  • Suita Municipal Hospital

    Suita-shi, Osaka, 564-0082

  • Hyogo Prefectural Awaji Hospital

    Sumoto, Hyōgo, 656-0013

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • Social Insurance Tagawa Hospital

    Tagawa, Fukuoka, 826-8585

  • Kagawa Prefectural Central Hospital

    Takamatsu, Kagawa-ken, 760-8557

  • Koseiren Takaoka Hospital

    Takaoka-shi, Toyama, 933-8555

  • Takarazuka Municipal Hospital

    Takarazuka, Hyōgo, 665-0827

  • Higashi Takarazuka Satoh Hospital

    Takarazukai, Hyōgo, 665-0873

  • Osaka Medical College

    Takatsuki, Osaka, 569-8686

  • Social Insurance Kinan Hospital

    Tanabe, Wakayama, 646-8588

  • Mie University Graduate School of Medicine

    Thu-shi, Mie-ken, 514-8507

  • Niigata Prefectural Tokamachi Hospital

    Tōkamachi, 948-0055

  • National Hospital Organization - Nishisaitama-Chuo National Hospital

    Tokorozawa, Saitama, 359-1151

  • National Defense Medical College

    Tokorozawa, Saitama, 359-8513

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503

  • Mita Hospital at the International University of Health and Welfare

    Tokyo, Tokyo, 108-8329

  • Tokyo Medical and Dental University

    Tokyo, Tokyo, 113-8519

  • Nippon Medical School

    Tokyo, Tokyo, 113-8603

  • Tokyo Metropolitan - Komagome Hospital

    Tokyo, Tokyo, 113-8677

  • Tokyo Women's Medical University Medical Center East

    Tokyo, Tokyo, 116-8567

  • Metropolitan Bokutoh Hospital

    Tokyo, Tokyo, 130-8575

  • Showa University Toyosu Hospital

    Tokyo, Tokyo, 135-8577

  • NTT Kanto Medical Center

    Tokyo, Tokyo, 141-8625

  • Toho University School of Medicine

    Tokyo, Tokyo, 143-8541

  • Japanese Red Cross Medical Center

    Tokyo, Tokyo, 150-8935

  • National Hospital Organization - Tokyo Medical Center

    Tokyo, Tokyo, 152-0021

  • International Medical Center of Japan

    Tokyo, Tokyo, 162-8655

  • Teikyo University School of Medicine

    Tokyo, Tokyo, 173-8605

  • Jikei University School of Medicine Hospital

    Tokyo, Tokyo, 25-8506

  • Takasago Kyoritsu Hospital

    Tokyo, Tokyo

  • Saiseikai Tondabayashi Hospital

    Tondabayashi, Osaka, 584-0082

  • Toyama Red Cross Hospital

    Toyama, Toyama, 930-0859

  • Toyama Prefectural Central Hospital

    Toyama, Toyama, 930-8550

  • National Hospital Organization Toyohashi Medical Center

    Toyohashi, Aichi-ken, 440-0836

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570

  • Koseiren Kamo Hospital

    Toyota, Aichi-ken, 471-8505

  • Tsuchiura Kyodo General Hospital

    Tsuchiura, Ibaraki, 300-0053

  • Yamaguchi University Graduate School of Medicine

    Ube, Yamaguchi, 755-8505

  • National Hospital Organization - Kumamotominami Hospital

    Uki, Kumamoto, 869-0

  • Juntendo Urayasu Hospital

    Urayasu-shi, Chiba, 279-0021

  • Tochigi Cancer Center

    Utsunomiya, Tochigi, 320-0834

  • Japan Labor Health and Welfare Organization Wakayama Rosai Hospital

    Wakayama, Wakayama, 640-8435

  • Wakayama Medical University

    Wakayama, Wakayama, 641-8509

  • Japanese Red Cross Society

    Wakayama, 640-8269

  • Yaizu Municipal Hospital

    Yaizu, Shizuoka, 425-8505

  • Yamagata Prefectural Central Hospital

    Yamagata, Yamagata, 990-2292

  • Yamagata Saisei Hospital

    Yamagata, Yamagata, 990-8545

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585

  • Kenseikai Nara Coloproctology Center

    Yamatotakada, Nara, 635-0022

  • Public Shiso General Hospital

    Yamsakicho, Hyōgo

  • Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital

    Yashiro, Kumamoto, 866-0826

  • Yatsushiro Health Insurance General Hospital

    Yatsushiro, Kumamoto, 866-8660

  • Showa University Northern Yokohama Hospital

    Yokohama, Kanagawa, 224-8503

  • Showa University Fujigaoka Hospital

    Yokohama, Kanagawa, 227-8502

  • Social Insurance Yokohama Central Hospital

    Yokohama, Kanagawa, 231-8553

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • Saiseikai Yokohama City Nanbu Hospital

    Yokohama, Kanagawa, 234-8503

  • Yokohama City Hospital

    Yokohama, Kanagawa, 240

  • St. Marianna University Yokohama City Seibu Hospital

    Yokohama, Kanagawa, 241-0811

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-0815

  • International Goodwill Hospital

    Yokohama, Kanagawa, 245-0006

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama, 230-0012

  • Yokohama City Minato Red Cross Hospital

    Yokohama, 231-8682

  • Hitachi Yokohama Hospital

    Yokohama, 244-0003

  • Yokosuka Kyosai Hospital

    Yokosuka, Kanagawa, 238-8558

  • Hiraka General Hospital

    Yokote, Akita, 013-8610

  • Tottori University - Faculty of Medicine

    Yonago, Tottori, 683-8503

  • University of Fukui Hospital

    Yoshida-gun, Fukui, 910-1193

  • Oita University Hospital

    Yufu-shi, Oita Prefecture, 879-5593

Other trials in Japan

About this study

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

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.

Read the detailed 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.

Being tested
UFT adjuvant chemotherapy
Keywords
stage II colon cancer, stage II rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UFT adjuvant chemotherapyDrug

    Also called Adjuvant chemotherapy with tegafur-uracil

    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.

Study groups in NCT00392899
Study groupRoleWhat they receive
UFT adjuvant therapy groupActive comparatorUFT 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.
Receives: Drug: UFT adjuvant chemotherapy
Observation groupNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 9 years

Secondary outcomes (2)

  1. Overall survival

    Overall survival is defined as time from date of enrollment until date of death from any cause.

    Measured: 9 years

  2. 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.

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionOct 2015
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,025 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00392899
Sponsor's protocol ID
CDR0000512573
Other IDs
TMDU-BRI-CC-05-01
Status last verified
Jul 2009
First submitted
25 Oct 2006
Last updated
28 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Ueno H, Ishiguro M, Nakatani E, Ishikawa T, Uetake H, Matsuda C, Nakamoto Y, Kotake M, Kurachi K, Egawa T, Yasumasa K, Murata K, Ikawa O, Shinji S, Murotani K, Matsui S, Teramukai S, Tomita N, Sugihara K; SACURA Study Group. Prospective Multicenter Study on the Prognostic and Predictive Impact of Tumor Budding in Stage II Colon Cancer: Results From the SACURA Trial. J Clin Oncol. 2019 Aug 1;37(22):1886-1894. doi: 10.1200/JCO.18.02059. Epub 2019 Jun 10.

    PubMed 31180819

  • Matsuda C, Ishiguro M, Teramukai S, Kajiwara Y, Fujii S, Kinugasa Y, Nakamoto Y, Kotake M, Sakamoto Y, Kurachi K, Maeda A, Komori K, Tomita N, Shimada Y, Takahashi K, Kotake K, Watanabe M, Mochizuki H, Nakagawa Y, Sugihara K; SACURA Study Group. A randomised-controlled trial of 1-year adjuvant chemotherapy with oral tegafur-uracil versus surgery alone in stage II colon cancer: SACURA trial. Eur J Cancer. 2018 Jun;96:54-63. doi: 10.1016/j.ejca.2018.03.009. Epub 2018 Apr 17.

    PubMed 29677641

  • Ishiguro M, Mochizuki H, Tomita N, Shimada Y, Takahashi K, Kotake K, Watanabe M, Kanemitsu Y, Ueno H, Ishikawa T, Uetake H, Matsui S, Teramukai S, Sugihara K. Study protocol of the SACURA trial: a randomized phase III trial of efficacy and safety of UFT as adjuvant chemotherapy for stage II colon cancer. BMC Cancer. 2012 Jul 7;12:281. doi: 10.1186/1471-2407-12-281.

    PubMed 22769569

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing UFT adjuvant chemotherapy in people with Colorectal Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 272 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 272 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (time frame: 9 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00392899, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.

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