Clinical trial NCT00088816: S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer
Official title: Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: stage IV gastric cancer
adenocarcinoma of the stomach
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Time to progression
measure: Tumor response
measure: Death related to treatment
measure: Histological response
measure: Postoperative complications
measure: Surgical/pathological curative resection
measure: Types of initial recurrence
measure: Adverse events
Other outcomes:
Locations:
city: Izumo-shi
country: Japan
facility: Shimane Prefectural Central Hospital
state: Shimane
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Kyoto
country: Japan
facility: National Hospital Organization - Kyoto Medical Center
city: Kyoto
country: Japan
facility: Kyoto-Katsura Hospital
city: Osaka
country: Japan
facility: Kitano Hospital
city: Osaka
country: Japan
facility: Kansai Denryoku Hospital
city: Yamato City Kanagawa
country: Japan
facility: Yamato Municipal Hospital
Study officials:
affiliation: Kyoto University Hospital
name: Seiji Satoh
role: STUDY_CHAIR
References:
citation: 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.