S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer

Gastric Cancer Clinical Trial

Official title:

Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00134095
• Other study ID #: CDR0000439474
• Secondary ID: FMUH-UHA-GC04-02
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 22, 2005
• Last updated: September 16, 2013
• Start date: September 2004

Study information

• Verified date: January 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• irinotecan hydrochloride

• tegafur-gimeracil-oteracil potassium

Procedure:
• adjuvant therapy

• conventional surgery

• neoadjuvant therapy

Locations

Country	Name	City	State
Japan	Asahikawa Kosei General Hospital	Asahikawa	Hokkaido
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Kobe City General Hospital	Kobe	Hyogo
Japan	Iwate Medical University Hospital	Morioka	Iwate
Japan	Yamamoto Kumiai General Hospital	Noshiro	Akita
Japan	Tsuruoka Municipal Shonai Hospital	Tsuruoka	Yamagata
Japan	Yamagata Prefectural Central Hospital	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
Fukushima Medical University Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor shrinkage			No
Primary	Historical tumor shrinkage			No
Primary	Overall survival			No
Primary	Progression-free survival			No
Primary	Median survival			No
Primary	Safety			Yes