AzTrials
AzTrials

Colorectal CancerNCT00898846

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

An observational study of Colorectal Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 152 sites in Japan.

Completed

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

Official record
Search all trials

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. 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
How many people
1,111 participants
Where
152 sitesJapan
Study dates
Oct 2006to Sep 2016
Phase
Observational
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

Study population: Patients with curatively resected stage II colon cancer in Japan.

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

Trial locations and contacts

152 sites in 1 country.

152 sites in 1 country

Japan152 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

  • 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

  • Asahikawa Medical College

    Asahikawa, Hokkaido, 078-8510

  • Otaru Ekisaikai Hospital

    Asahikawa, Hokkaido, 078-8510

  • Kanagawa Prefectural Ashigawa-kami Hospital

    Ashigarakami-gun, Kanagawa, 258-0003

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

  • Chigasaki Municipal Hospital

    Chigasaki, 253-0083, 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

  • Tokyo Metropolitan Fuchu Hospital

    Fuchū, Tokyo, 183-8524

  • Fujieda Municipal General Hospital

    Fujieda, Shizuoka, 426-8677

  • 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

  • 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

  • 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 University Hospital

    Hiroshima, Hiroshima, 734-8551

  • 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

  • Asahi General Hospital

    Inba-gunn, Chiba, 270-1694

  • Rinku General Medical Center

    Izumisano, Osaka, 598-8577

  • Shimane Prefectural Central Hospital

    Izumo-shi, Shimane, 693-0068

  • Nanpuh Hospital

    Kagoshima, Kagoshima-ken, 892-8512

  • Kakogawa Municipal Hospital

    Kakogawa, Hyōgo, 675-8611

  • Kitasato University School of Medicine

    Kanagawa, Kanagawa, 228-8555

  • Kyoto Second Red Cross Hospital

    Kanigyou-ku, Kyoto, 602-8026

  • Saitama Medical School Hospital

    Kawagoe-shi, Saitama, 350-8550

  • Kanto Rosai Hospital

    Kawasaki, Kanagawa, 211-8510

  • Kitakyushu Municipal Medical Center

    Kitakyushu, Fukuoka, 802-0077

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • Kobe City General Hospital

    Kobe, Hyōgo, 650-0046

  • 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

  • Shouwa General Hospital

    Kodaira, Tokyo, 187-0004

  • Daisan Hospital

    Komae, Tokyo, 201

  • Showa-Inan General Hospital

    Komagane, Nagano, 399-4191

  • 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

  • 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

  • Gunma University Graduate School of Medicine

    Maebashi, Gunma, 371-8511

  • Aizawa Hospital

    Matsumoto, Nagano, 390-8510

  • Minoh City Hospital

    Mino, Osaka, 562-0014

  • Kyorin University School of Medicine - Mitaka Campus

    Mitaka, Tokyo, 181-8611

  • Miyoshi Central Hospital

    Miyoshi, Hiroshima, 728-8502

  • Nagahama City Hospital

    Nagahama, Shiga, 526-8580

  • Nagano Red Cross Hospital

    Nagano, Nagano, 380-0

  • Nagano Municipal Hospital

    Nagano, Nagano, 381-8551

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • Nagoya Ekisaikai Hospital

    Nagoya, Aichi-ken, 454-8502

  • Ban Buntane Houtokukai Hospital

    Nagoya, Aichi-ken, 454-8509

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8550

  • Nagoya University School of Medicine

    Nagoya, Aichi-ken, 466

  • Nagoya Midori Municipal Hospital

    Nagoya, Aichi-ken

  • Hokushin Hospital

    Nakano, Nagano, 383-0021

  • Kochi Medical School

    Nankoku, Kochi, 783-8505

  • Saiseikai Nara Hospital

    Nara, Nara, 6308145

  • 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

  • Hyogo College of Medicine

    Nishinomiya, Hyōgo, 663-8501

  • Yamamoto Kumiai General Hospital

    Noshiro, Akita, 016-0014

  • Ogaki Municipal Hospital

    Ogaki-shi, Gifu, 503-8502

  • Okayama University Medical School

    Okayama, Okayama-ken, 700-8558

  • Aichi Prefectural Hospital

    Okazaki, Aichi-ken

  • Kitano Hospital

    Osaka, Osaka, 530-8480

  • Osaka City Juso Hospital

    Osaka, Osaka, 532-0

  • Osaka City General Hospital

    Osaka, Osaka, 534-0021

  • 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

  • Osaka Saiseikai Noe Hospital

    Osaka, Osaka, Joto-ku

  • Minamiosaka Hospital

    Osaka, Osaka

  • Osaka Red Cross Hospital

    Osaka, 543-8555

  • Hirosaki University, School of Medicine

    Otaru-shi, Hokkaido, 047-0031

  • Gunma Cancer Center

    Otashi, Gunma, 373-8550

  • Otsu Municipal Hospital

    Ōtsu, Shiga, 520-0804

  • Saitama Social Insurance Hospital

    Saitama, Saitama, 330-0074

  • Osaka Rosai Hospital

    Sakai-shi, Osaka, 591-8025

  • 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

  • Tohoku Rosai Hospital

    Sendai, Miyagi, 981-0911

  • National Hospital Organization - Kanmon Medical Center

    Shimonoseki, Yamaguchi, 240-8555

  • Shimonoseki Kosei Hospital

    Shimonoseki, Yamaguchi, 750-0061

  • Jichi Medical School

    Shimotsuke-shi, Tochigi, 329-0498

  • 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

  • Suita Municipal Hospital

    Suita-shi, Osaka, 564-0082

  • Hyogo Prefectural Awaji Hospital

    Sumoto, Hyōgo, 656-0013

  • 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

  • National Defense Medical College

    Tokorozawa, Saitama, 359-8513

  • Mita Hospital at the International University of Health and Welfare

    Tokyo, Tokyo, 108-8329

  • Tokyo Medical and Dental University

    Tokyo, Tokyo, 113-8510

  • Nippon Medical School

    Tokyo, Tokyo, 113-8603

  • Toho University School of Medicine

    Tokyo, Tokyo, 143-8541

  • Japanese Red Cross Medical Center

    Tokyo, Tokyo, 150-8935

  • International Medical Center of Japan

    Tokyo, Tokyo, 162-8655

  • Teikyo University School of Medicine

    Tokyo, Tokyo, 173-8605

  • Itabashi Chuo Medical Center

    Tokyo, Tokyo, 174-8691

  • Takasago Kyoritsu Hospital

    Tokyo, Tokyo

  • Saiseikai Tondabayashi Hospital

    Tondabayashi, Osaka, 584-0082

  • Yamaguchi University Graduate School of Medicine

    Ube, Yamaguchi, 755-8505

  • National Hospital Organization - Kumamotominami Hospital

    Uki, Kumamoto, 869-0

  • Tochigi Cancer Center

    Utsunomiya, Tochigi, 320-0834

  • Yaizu Municipal Hospital

    Yaizu, Shizuoka, 425-8505

  • Yamagata Prefectural Central Hospital

    Yamagata, Yamagata, 990-2292

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585

  • Kenseikai Nara Coloproctology Center

    Yamatotakada, Nara, 635-0022

  • Yatsushiro Health Insurance General Hospital

    Yatsushiro, Kumamoto, 866-8660

  • Yokohama City Hospital

    Yokohama, Kanagawa, 240

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-0815

  • International Goodwill Hospital

    Yokohama, Kanagawa, 245-0006

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

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.

Read the 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.

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 NCT00898846
Study groupRoleWhat they receive
UFT adjuvant therapy groupUFT 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 groupPatients 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. 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.

    Measured: 9years

Secondary outcomes (2)

  1. Analysis of microsatellite instability (MSI) and chromosomal instability (CIN)

    MSI and CIN (i.e., 18q LOH) are analyzed using paraffin embedded samples.

    Measured: At enrollment

  2. 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.

    Measured: At enrollment

Timeline

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

  1. First posted12 May 2009 (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
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00898846
Sponsor's protocol ID
CDR0000551714
Other IDs
TMDU-BRI-CC-05-02
Status last verified
Sep 2016
First submitted
9 May 2009
Last updated
28 Sep 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 152 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 152 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.

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?

mRNA levels (time frame: 9years). 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 NCT00898846.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in