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

This study has been completed.
Sponsor:
Collaborator:
Tokyo Medical and Dental University
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00392899
First received: October 25, 2006
Last updated: September 26, 2016
Last verified: July 2009

October 25, 2006
September 26, 2016
October 2006
October 2015   (final data collection date for primary outcome measure)
Disease-free survival [ Time Frame: 9 years ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00392899 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: 9 years ] [ Designated as safety issue: No ]
    Overall survival is defined as time from date of enrollment until date of death from any cause.
  • Types and severities of adverse events [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    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.
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Not Provided
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Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
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.
Other Name: Adjuvant chemotherapy with tegafur-uracil
  • Active Comparator: UFT adjuvant therapy group
    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. 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.
    Intervention: Drug: UFT adjuvant chemotherapy
  • No Intervention: Observation group
    Patients 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2025
September 2016
October 2015   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00392899
CDR0000512573, TMDU-BRI-CC-05-01
Yes
Not Provided
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Translational Research Informatics Center, Kobe, Hyogo, Japan
Translational Research Informatics Center, Kobe, Hyogo, Japan
Tokyo Medical and Dental University
Study Chair: Kenichi Sugihara, MD, PhD Tokyo Medical and Dental University
Translational Research Informatics Center, Kobe, Hyogo, Japan
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP