NCT00182611

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether giving S-1 together with cisplatin before surgery is more effective than surgery followed by S-1 in treating stomach cancer. PURPOSE: This randomized phase III trial is studying how well giving S-1 together with cisplatin before surgery works compared to surgery followed by S-1 in treating patients with stage III stomach cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at below P25 for phase_3 gastric-cancer

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

6 active sites

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

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

June 26, 2013

Status Verified

November 1, 2008

Enrollment Period

4.4 years

First QC Date

September 15, 2005

Last Update Submit

June 25, 2013

Conditions

Gastric Cancer

Keywords

stage III gastric canceradenocarcinoma of the stomach

Outcome Measures

Primary Outcomes (1)

  • Overall survival

Secondary Outcomes (7)

  • Progression-free survival (PFS)

  • Postoperative PFS

  • Surgical/pathological curative resection

  • Death related to treatment

  • Death related to operation

  • +2 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, including type II or type III adenocarcinoma of the esophagogastric junction * Stage III disease * T3 or T4 and/or N2 * No stage IV disease * Helical CT scan and laparoscopic staging required * Potentially resectable disease PATIENT CHARACTERISTICS: Age * 20 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * WBC ≥ 4,000/mm³, but \< 12,000/mm³ * Granulocyte count ≥ 2,000/mm³ * Platelet count ≥ 100,000/mm³ * 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 * Arterial oxygen pressure (PaO\_2) ≥ 70 mm Hg on room air Other * Able to take oral medications 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 (6)

Fukui Red Cross Hospital

Fukui-shi, Fukui, 918-8501, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

National Hospital Organization - Kyoto Medical Center

Kyoto, Kyoto, 612-0861, Japan

Location

Yamato Municipal Hospital

Yamatotakada, Nara, 635-8501, Japan

Location

Kitano Hospital

Osaka, Osaka, 530-8480, Japan

Location

Shimane Prefectural Central Hospital

Izumo-shi, Shimane, 693-0068, Japan

Location

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 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 16, 2005

Study Start

April 1, 2004

Primary Completion

September 1, 2008

Study Completion

November 1, 2008

Last Updated

June 26, 2013

Record last verified: 2008-11

Locations

JP(6)