NCT00152243

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3 gastric-cancer

Timeline
Completed

Started Jun 1997

Longer than P75 for phase_3 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1997

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

July 7, 2011

Status Verified

July 1, 2011

Enrollment Period

8.8 years

First QC Date

September 8, 2005

Last Update Submit

July 6, 2011

Conditions

Gastric Cancer

Keywords

Stomach Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival and relapse-free survival

    every course for first three courses, then every other course

Secondary Outcomes (1)

  • Adverse events

    any time

Study Arms (2)

1

EXPERIMENTAL

UFT (uracil, tegafur)

Drug: UFT (uracil, tegafur)

2

OTHER

Surgery alone

Procedure: Surgery alone

Interventions

UFT (uracil, tegafur)DRUG

uracil-tegafur 360 mg per square meter per day orally 16 months

1
Surgery alonePROCEDURE

Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer.

2

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior anticancer treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute Hospital, Japanese Foundation for Cancer Research

3-10-6, Ariake, Koto-ku, Tokyo, Japan

Location

Related 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 serosa-negative, locally advanced gastric cancer. Br J Surg. 2007 Dec;94(12):1468-76. doi: 10.1002/bjs.5996.

    PMID: 17948223RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

TegafurUracilSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

FluorouracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Toshifusa Nakajima, MD

    Cancer Institute Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

June 1, 1997

Primary Completion

March 1, 2006

Study Completion

August 1, 2007

Last Updated

July 7, 2011

Record last verified: 2011-07

Locations

JP(1)