PER-025-05
Completed
未知
OPEN STUDY, MULTICENTER, RANDOMIZED, PHASE 3, OF S-1 IN COMBINATION WITH CISPLATINE COMPARED AGAINST 5-FU IN COMBINATION WITH CISPLATINO, IN PATIENTS WITH ADVANCED GASTRIC CANCER NOT TREATED PREVIOUSLY WITH CHEMOTHERAPY FOR ADVANCED DISEASE
TAIHO PHARMA USA INC.,0 sites35 target enrollmentJune 16, 2005
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- -C169 Stomach, unspecified
- Sponsor
- TAIHO PHARMA USA INC.,
- Enrollment
- 35
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. You have granted written consent.
- •2\. Has metastatic or locally advanced gastric cancer (Stage IV) histologically confirmed, not resectable.
- •3\. Has a measurable or measurable but not measurable disease.
- •4\. No previous palliative chemotherapy is allowed.
- •5\. You can take medications orally.
- •6\. You are\> 18 years old.
- •7\. At least 3 weeks of previous major surgery occurred.
- •8\. At least 4 weeks of previous radiotherapy were passed.
- •9\. Has an activity status 0 to 1 according to ECOG.
- •10\. It has an adequate organic function.
Exclusion Criteria
- •1\. Patients who have had treatment with any of the following: a) Any prior palliative chemotherapy or any prior therapy for malignancy. b) Coadjuvant or neoadjuvant therapy within the last 12 months. c \= Concurrent treatment with an anticancer agent in research. d \= Previous cisplatin as neo\-adjuvant chemotherapy and / or adjuvant with cumulative doses\> 300 mg / m2\. e)\> 25% of irradiated medullary bone. f) Concurrent treatment with an agent under investigation or within 30 days of randomization. g) Current enrollment in another clinical study.
- •2\. Has a serious illness.
- •3\. Patient is receiving concomitant treatment with drugs that interact with S\-1\.
- •4\. Patient is receiving concomitant treatment with drugs that interact with 5\-FU.
- •5\. Patient is receiving concomitant treatment with drugs that interact with cisplatin.
- •6\. Patient is is a woman and is pregnant or breastfeeding.
- •7\. Has a known hypersensitivity to 5\-FU or cisplatin.
- •8\. Patients with reproductive potential who refuse to use adequate contraception
Outcomes
Primary Outcomes
Not specified
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