A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-10-31

Study Completion Date

2008-02-29

Brief Summary

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This is a controlled study designed to compare relapse-free survival and overall survival in patients receiving UFT with those in patients receiving surgery alone. Patients will be randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 12 months after the start of treatment.Evaluations will be separately done for colon cancer and rectal cancer.

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Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

UFT (uracil, tegafur)

Group Type EXPERIMENTAL

UFT (uracil, tegafur)

Intervention Type DRUG

to receive oral uracil-tegafur 400 mg square meter for one year

2

Surgery alone

Group Type OTHER

Surgery alone

Intervention Type PROCEDURE

Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal cancer.

Interventions

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UFT (uracil, tegafur)

to receive oral uracil-tegafur 400 mg square meter for one year

Intervention Type DRUG

Surgery alone

Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal cancer.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 20 to 75
* Performance status 0 , 1, or 2 (ECOG)
* Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3
* Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.2mg/dL
* Renal BUN ≤ 25mg/dL Creatinine ≤ 1.5mg/dL