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

Gastric Cancer Clinical Trial

Official title:

A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone for Serosa-negative Advanced Gastric Cancer (NSAS-GC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152243
• Other study ID #: 01023003
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: July 6, 2011
• Start date: June 1997
• Est. completion date: August 2007

Study information

• Verified date: July 2011
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

This is a controlled study designed to evaluate the efficacy of UFT on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment response, 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 16 months after the start of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2007
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 = 1.5 times ULN

• Renal BUN =1.5 times ULN Creatinine = 1.5 times ULN

Exclusion Criteria:

• Prior anticancer treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• UFT (uracil, tegafur)
uracil-tegafur 360 mg per square meter per day orally 16 months

Procedure:
• Surgery alone
Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer.

Locations

Country	Name	City	State
Japan	Cancer Institute Hospital, Japanese Foundation for Cancer Research	3-10-6, Ariake, Koto-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Nakajima T, Kinoshita T, Nashimoto A, Sairenji M, Yamaguchi T, Sakamoto J, Fujiya T, Inada T, Sasako M, Ohashi Y; National Surgical Adjuvant Study of Gastric Cancer Group. Randomized controlled trial of adjuvant uracil-tegafur versus surgery alone for ser — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival and relapse-free survival		every course for first three courses, then every other course	No
Secondary	Adverse events		any time	Yes