S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer
Recruitment status was Active, not recruiting
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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 |
- 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) |
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 |
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| 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 | |
| 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: | October 30, 2010 |
| 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 S 1 (combination) Irinotecan Camptothecin |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013