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NCT Number: NCT00392899

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aichi Medical University, Aichi-gun, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UFT adjuvant chemotherapy

Drug

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 names: Adjuvant chemotherapy with tegafur-uracil

Primary outcomes

  1. Disease-free survival

    Time frame: 9 years

    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.

Secondary outcomes

  1. Overall survival

    Time frame: 9 years

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

  2. Types and severities of adverse events

    Time frame: 15 months

    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.

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Tokyo Medical and Dental University

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2015
Study completion
2016
First posted
Oct 26, 2006
Registry last updated
Sep 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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