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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00134095
First received: August 22, 2005
Last updated: September 16, 2013
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: irinotecan hydrochloride
Drug: tegafur-gimeracil-oteracil potassium
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor shrinkage [ Designated as safety issue: No ]
  • Historical tumor shrinkage [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Median survival [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: September 2004
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134095

Locations
Japan
Yamamoto Kumiai General Hospital
Noshiro, Akita, Japan, 016-0014
Asahikawa Kosei General Hospital
Asahikawa, Hokkaido, Japan, 078-8211
Kobe City General Hospital
Kobe, Hyogo, Japan, 650
Iwate Medical University Hospital
Morioka, Iwate, Japan, 020-8505
Tsuruoka Municipal Shonai Hospital
Tsuruoka, Yamagata, Japan, 997-8515
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Yamagata Prefectural Central Hospital
Yamagata, Japan, 990-2292
Sponsors and Collaborators
Fukushima Medical University Hospital
Investigators
Study Chair: Mitsukazu Gotoh, MD Fukushima Medical University Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00134095     History of Changes
Other Study ID Numbers: CDR0000439474, FMUH-UHA-GC04-02
Study First Received: August 22, 2005
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the stomach
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Tegafur
Irinotecan
Camptothecin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014