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Randomized Phase III Study of UFT+Leucovorin vs. TS-1 as Adjuvant Treatment for Stage III Colon Cancer , and Investigate Predictive Factors Based on Gene Expression


Phase 3
20 Years
80 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Randomized Phase III Study of UFT+Leucovorin vs. TS-1 as Adjuvant Treatment for Stage III Colon Cancer , and Investigate Predictive Factors Based on Gene Expression


OBJECTIVES:

- Compare the disease-free survival of patients with stage III colon cancer treated with
S-1 or tegafur-uracil and leucovorin calcium after curative surgery .

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral tegafur-uracil and oral leucovorin calcium 3 times daily
on days 1-21. Treatment repeats every 5 weeks for up to 5 courses.

- Arm II: Patients receive oral S-1 twice daily on days 1-28. Treatment repeats every 6
weeks for up to 4 courses.

Biological samples are collected for gene expression analysis for identification of
predictive markers.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of colon

- Stage III (T1-4, N1-3, M0) disease

- Has undergone surgical resection of the tumor within the past 8 weeks

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Able to take medications orally

- WBC ≥ 3,500/mm³ and < 12,000/mm³

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9.0 g/dL

- Total bilirubin ≤ 2.0 mg/dL

- AST/ALT ≤ 100 IU/L

- Creatinine ≤ 1.2 mg/dL

- No other active malignancies

- Must have none of the following comorbidities:

- Severe postoperative complications

- Uncontrollable diabetes mellitus

- Uncontrollable hypertension

- Myocardial infraction within 6 months

- Unstable angina pectoris

- Hepatocirrhosis

- Interstitial pneumonia, pulmonary fibrosis, or severe emphysema

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or radiotherapy for colon cancer

- No concurrent radiotherapy

- No concurrent biological response modifiers

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:

No

Principal Investigator

Kenichi Sugihara, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tokyo Medical and Dental University

Authority:

United States: Federal Government

Study ID:

CDR0000593164

NCT ID:

NCT00660894

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the colon
  • stage III colon cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

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