NCT00150670

Brief Summary

This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy compared with the monotherapy by TS-1 alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P25-P50 for phase_3 gastric-cancer

Timeline
Completed

Started Mar 2002

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

March 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 7, 2011

Status Verified

July 1, 2011

Enrollment Period

4.8 years

First QC Date

September 7, 2005

Last Update Submit

July 6, 2011

Conditions

Gastric Cancer

Keywords

Stomach cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    every course for first three courses, then every other course

Secondary Outcomes (1)

  • Overall response rate, lesion-directed response rate, time to treatment failure (TTF), hospitalization-free survival period within the periods of TTF, and safety profile

    every course for first three courses, then every other course

Study Arms (2)

1

EXPERIMENTAL

TS-1 and cisplatin

Drug: TS-1 and cisplatin

2

ACTIVE COMPARATOR

TS-1

Drug: TS-1

Interventions

TS-1 and cisplatinDRUG

TS-1(40-60 mg per body surface area) was given orally, twice daily for 3 consecutive weeks, and 60 mg/m2 cisplatin was given intravenously on day 8, followed by a 2-week rest period, within a 5-week cycle.

1
TS-1DRUG

TS-1(40-60 mg per body surface area) was given orally, twice daily for 4 consecutive weeks, followed by a 2-week rest period, within a 6-week cycle.

2

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed adenocarcinoma
  • Unresectable and recurrent gastric cancer
  • Age 20 to 74
  • Performance status 0, 1, or 2 (ECOG)
  • Life expectancy 3 months
  • No prior chemotherapy or radiotherapy for gastric cancer
  • Able to take oral medication
  • Evaluable or not evaluable lesion had already checked more than 28 days before participated in this study
  • Hematopoietic Absolute granulocyte count lower limit of normal-12,000/mm\^3 Platelet ≥ 100,000/mm\^3 Hemoglobin ≥ 8.0 g/dL
  • Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL
  • Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 50 mL/min

You may not qualify if:

  • Pregnant or nursing
  • Bleeding from gastrointestinal tract or no diarrhea
  • Hypersensitivity to TS-1 or CDDP
  • Psychiatric disorder that would preclude study compliance or giving informed consent
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality
  • Serious illness or medical condition
  • Brain metastasis
  • Ascites requiring drainage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Hospital, Kitasato University

2-1-1, Asamizodai, Sagamihara, Kanagawa, Japan

Location

Related Publications (2)

  • Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol. 2008 Mar;9(3):215-21. doi: 10.1016/S1470-2045(08)70035-4. Epub 2008 Feb 20.

    PMID: 18282805RESULT

  • Arai H, Takeuchi M, Ichikawa W, Shitara K, Sunakawa Y, Oba K, Koizumi W, Sakata Y, Furukawa H, Yamada Y, Takeuchi M, Fujii M. Correlation of multiple endpoints in the first-line chemotherapy of advanced gastric cancer: Pooled analysis of individual patient data from Japanese Phase III trials. Cancer Med. 2024 Jan;13(1):e6818. doi: 10.1002/cam4.6818. Epub 2023 Dec 23.

    PMID: 38140879DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

titanium silicideCisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Wasaburo Koizumi, MD, PHD

    East Hospital, Kitasato University

    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 7, 2005

First Posted

September 8, 2005

Study Start

March 1, 2002

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

July 7, 2011

Record last verified: 2011-07

Locations

JP(1)