S-1 and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage III Stomach Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, 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 removed. It is not yet known whether giving S-1 together with cisplatin before surgery is more effective than surgery followed by S-1 in treating stomach cancer.
PURPOSE: This randomized phase III trial is studying how well giving S-1 together with cisplatin before surgery works compared to surgery followed by S-1 in treating patients with stage III stomach cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: cisplatin Drug: tegafur-gimeracil-oteracil potassium Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Phase III Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Potentially Resectable Stage III Advanced Gastric Cancer |
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival (PFS) [ Designated as safety issue: No ]
- Postoperative PFS [ Designated as safety issue: No ]
- Surgical/pathological curative resection [ Designated as safety issue: No ]
- Death related to treatment [ Designated as safety issue: No ]
- Death related to operation [ Designated as safety issue: No ]
- Postoperative complications [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2004 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Compare the overall survival of patients with potentially resectable stage III gastric cancer treated with neoadjuvant S-1 and cisplatin followed by gastrectomy and adjuvant S-1 vs no neoadjuvant chemotherapy before gastrectomy and adjuvant S-1.
Secondary
- Compare the progression-free survival of patients treated with these regimens.
- Compare the curative resection rates in patients treated with these regimens.
- Compare the safety of these regimens, in terms of postoperative complications, adverse events, and treatment- or surgery-related mortality rate, in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T3 vs T4) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I (control): Patients undergo gastrectomy with D2+ lymph node dissection. Patients then receive adjuvant oral S-1.
- Arm II (neoadjuvant therapy): Patients receive neoadjuvant 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. Patients then undergo surgery and receive adjuvant S-1 as in arm I.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed gastric adenocarcinoma, including type II or type III adenocarcinoma of the esophagogastric junction
Stage III disease
T3 or T4 and/or N2
- No stage IV disease
- Helical CT scan and laparoscopic staging required
- Potentially resectable disease
PATIENT CHARACTERISTICS:
Age
- 20 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 4,000/mm³, but < 12,000/mm³
- Granulocyte count ≥ 2,000/mm³
- Platelet count ≥ 100,000/mm³
- 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
- Arterial oxygen pressure (PaO_2) ≥ 70 mm Hg on room air
Other
- Able to take oral medications
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
Contacts and Locations| Japan | |
| Yamato Municipal Hospital | |
| Yamatotakada, Nara, Japan, 635-8501 | |
| Shimane Prefectural Central Hospital | |
| Izumo-shi, Shimane, Japan, 693-0068 | |
| Fukui Red Cross Hospital | |
| Fukui, Japan, 918-8501 | |
| National Hospital Organization - Kyoto Medical Center | |
| Kyoto, Japan, 612-0861 | |
| Kyoto University Hospital | |
| Kyoto, Japan, 606-8507 | |
| Kitano Hospital | |
| Osaka, Japan, 530-8480 | |
| Study Chair: | Seiji Satoh | Kyoto University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00182611 History of Changes |
| Other Study ID Numbers: | CDR0000426403, KYUH-UHA-GC04-03 |
| Study First Received: | September 15, 2005 |
| Last Updated: | October 30, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III gastric cancer adenocarcinoma of the stomach |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases S 1 (combination) Cisplatin |
Tegafur Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013