NCT00088816

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works in treating patients who are undergoing surgery for stage IV gastric cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 gastric-cancer

Geographic Reach
1 country

7 active sites

Status
unknown

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

April 1, 2003

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Last Updated

September 17, 2013

Status Verified

March 1, 2008

Enrollment Period

4.9 years

First QC Date

August 4, 2004

Last Update Submit

September 16, 2013

Conditions

Gastric Cancer

Keywords

stage IV gastric canceradenocarcinoma of the stomach

Outcome Measures

Primary Outcomes (1)

  • Overall survival

Secondary Outcomes (8)

  • Time to progression

  • Tumor response

  • Death related to treatment

  • Histological response

  • Postoperative complications

  • +3 more secondary outcomes

Interventions

cisplatinDRUG
tegafur-gimeracil-oteracil potassiumDRUG
adjuvant therapyPROCEDURE
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed gastric adenocarcinoma * Stage IV disease meeting 1 of the following staging criteria according to Japanese gastric cancer classification: * T4, N2 * T4, N3 * P1, CY1 * CT scan and laparoscopic staging required PATIENT CHARACTERISTICS: Age * 20 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * WBC ≥ 4,000/mm\^3 AND \< 12,000/mm\^3 * Granulocyte count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL Hepatic * AST and ALT ≤ 2.5 times upper limit of normal * Bilirubin ≤ 1.5 mg/dL Renal * Creatinine clearance ≥ 50 mL/min Pulmonary * PaO\_2 ≥ 70 mm Hg on room air Other * Able to swallow oral medication PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for gastric cancer Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for gastric cancer Surgery * No prior surgery for gastric cancer Other * No other prior therapy for gastric cancer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

National Hospital Organization - Kyoto Medical Center

Kyoto, Kyoto, 612-0861, Japan

Location

Kyoto-Katsura Hospital

Kyoto, Kyoto, 615-8256, Japan

Location

Kitano Hospital

Osaka, Osaka, 530-8480, Japan

Location

Kansai Denryoku Hospital

Osaka, Osaka, 553-0003, Japan

Location

Shimane Prefectural Central Hospital

Izumo-shi, Shimane, 693-0068, Japan

Location

Yamato Municipal Hospital

Yamato City Kanagawa, 242-8602, Japan

Location

Related Publications (1)

  • Satoh S, Okabe H, Teramukai S, Hasegawa S, Ozaki N, Ueda S, Tsuji A, Sakabayashi S, Fukushima M, Sakai Y. Phase II trial of combined treatment consisting of preoperative S-1 plus cisplatin followed by gastrectomy and postoperative S-1 for stage IV gastric cancer. Gastric Cancer. 2012 Jan;15(1):61-9. doi: 10.1007/s10120-011-0066-9. Epub 2011 Jun 11.

    PMID: 21667134RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

CisplatinChemotherapy, AdjuvantNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Seiji Satoh

    Kyoto University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2004

First Posted

August 5, 2004

Study Start

April 1, 2003

Primary Completion

March 1, 2008

Last Updated

September 17, 2013

Record last verified: 2008-03

Locations

JP(7)