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NCT Number: NCT00152230

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

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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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Cancer Center Hospital East

6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan

Who can participate

Healthy volunteers accepted: No

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

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

Exclusion criteria

  • Prior anticancer treatment

Treatment and study plan

UFT (uracil, tegafur)

Drug

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

Surgery alone

Procedure

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

Primary outcomes

  1. Relapse-free survival and overall survival

    Time frame: every course for first three courses, then every other course

Secondary outcomes

  1. Adverse events

    Time frame: any time

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone in Patients With Dukes C Colorectal Cancer (NSAS-CC)

Important dates

Study start
1996
Primary completion
2006
Study completion
2008
First posted
Sep 9, 2005
Registry last updated
Jul 7, 2011

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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