Suspended

S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer

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What is being tested

cisplatin

+ tegafur-gimeracil-oteracil potassium
+ adjuvant therapy
Drug
Procedure
Who is being recruted

Gastric Cancer

Over 20 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2003

See protocol details

Summary

Principal SponsorKyoto University
Last updated: September 17, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2003Actual date on which the first participant was enrolled.

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. OBJECTIVES: Primary * Determine the efficacy and feasibility of neoadjuvant chemotherapy comprising S-1 and cisplatin in patients with stage IV gastric adenocarcinoma. * Determine the overall survival of patients treated with this regimen. Secondary * Determine the time to progression and types of initial recurrence in patients treated with this regimen. * Determine tumor response in patients treated with this regimen. * Determine mortality and morbidity related to treatment in these patients. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral S-1 on days 1-21 and cisplatin IV over 2 hours on day 8. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. Patients resume oral S-1 after surgery. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Official TitlePhase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer 
Principal SponsorKyoto University
Last updated: September 17, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
50 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 20 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Gastric Cancer
Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 7 locations
Suspended
Shimane Prefectural Central HospitalIzumo-shi, JapanSee the location
Suspended
Kyoto University HospitalKyoto, Japan
Suspended
National Hospital Organization - Kyoto Medical CenterKyoto, Japan
Suspended
Kyoto-Katsura HospitalKyoto, Japan
Suspended7 Study Centers