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

Sponsored by:	Tokyo Medical and Dental University
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00392899

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 Procedure: adjuvant therapy Procedure: observation	Phase III

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Tegafur Uracil

U.S. FDA Resources

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

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
Estimated Primary Completion Date:	September 2014 (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 191 Study Locations

Sponsors and Collaborators

Tokyo Medical and Dental University

Investigators

Study Chair:

Kenichi Sugihara, MD

Tokyo Medical and Dental University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000512573, TMDU-BRI-CC-05-01
Study First Received:	October 25, 2006
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00392899
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage II colon cancer
stage II rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Study placed in the following topic categories:

Digestive System Neoplasms
Tegafur
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Rectal neoplasm
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009