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:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00392899
First received: October 25, 2006
Last updated: December 17, 2013
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: tegafur-uracil
Other: clinical observation
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 2000
Study Start Date: October 2006
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392899

  Show 272 Study Locations
Sponsors and Collaborators
Tokyo Medical and Dental University
Investigators
Study Chair: Kenichi Sugihara, MD, PhD Tokyo Medical and Dental University
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00392899     History of Changes
Other Study ID Numbers: CDR0000512573, TMDU-BRI-CC-05-01
Study First Received: October 25, 2006
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II colon cancer
stage II rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Tegafur
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014