Clinical trial NCT00134095: S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer
Official title: Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: adenocarcinoma of the stomach
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-08-24
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as S-1 and irinotecan, 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 completely removed.

PURPOSE: This phase II trial is studying how well giving S-1 together with irinotecan works in treating patients who are undergoing surgery for locally advanced stomach cancer.

Detailed description: OBJECTIVES:

Primary

* Determine the efficacy of neoadjuvant S-1 and irinotecan in patients with locally advanced gastric cancer.

Secondary

* Determine the histological response in patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.
* Determine the progression-free survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Determine postoperative morbidity in patients treated with this regimen.
* Determine the rate of potentially curative surgery in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral S-1 on days 1-21 and irinotecan IV over 90 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. After surgery, patients resume treatment with S-1 alone as before for 1 year.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed gastric adenocarcinoma

  * Locally advanced disease

    * Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)
* Planning to undergo curative surgery after neoadjuvant chemotherapy

PATIENT CHARACTERISTICS:

Age

* 20 to 75

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* WBC 4,000-12,000/mm\^3
* Granulocyte count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL

Hepatic

* AST and ALT ≤ 100 U/L
* Bilirubin ≤ 1.5 mg/dL

Renal

* Creatinine normal OR
* Creatinine clearance ≥ 50 mL/min

Pulmonary

* PaO_2 \> 60 mm Hg on room air

Other

* Able to swallow oral medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior biologic therapy for gastric cancer

Chemotherapy

* No prior chemotherapy for gastric cancer

Endocrine therapy

* No prior endocrine therapy for gastric cancer

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: Tumor shrinkage
measure: Historical tumor shrinkage
measure: Overall survival
measure: Progression-free survival
measure: Median survival
measure: Safety
Secondary outcomes:
Other outcomes:
Locations:
city: Noshiro
country: Japan
facility: Yamamoto Kumiai General Hospital
state: Akita
city: Asahikawa
country: Japan
facility: Asahikawa Kosei General Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City General Hospital
state: Hyogo
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Tsuruoka
country: Japan
facility: Tsuruoka Municipal Shonai Hospital
state: Yamagata
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Yamagata
country: Japan
facility: Yamagata Prefectural Central Hospital
Study officials:
affiliation: Fukushima Medical University Hospital
name: Mitsukazu Gotoh, MD
role: STUDY_CHAIR
References: