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

Not Applicable

• Conditions: -C169 Stomach, unspecified; Stomach, unspecified; C169

• Registration Number: PER-025-05
• Lead Sponsor: TAIHO PHARMA USA INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-16
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 35

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.
11. Is willing and able to comply with scheduled visits, treatment plans, laboratory analyzes and other study procedures

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation<br>Measure:General survival: time from randomization to patient death<br>Timepoints:At the time of the event<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Global response index (ORR): Computed tomography and chest x-ray.<br>Duration of the response (DR). Time to tumor response (TTR): Clinical evaluation.<br>Survival without progression (PFS): Until the moment of progression or death of the patient.<br>Time to treatment failure (TTF): Moment in which disease progression occurs, discontinuation or death from any cause.<br>Clinical benefit: ECOG activity status and weight loss.<br>Measure:Global response index (ORR). Duration of the response (DR). Time to the tumor response (TTR). Survival without progression (PFS). Time to tumor progression (TTP). Time to treatment failure (TTF). Clinical benefit<br>Timepoints:Global response index (ORR). Duration of the response (DR). Time to the tumor response (TTR). Clinical benefit: Clinical evaluation at the beginning of each cycle.<br>Survival without progression (PFS). Time to treatment failure (TTF): Moment in which disease progression occurs, discontinuation or death from any cause.<br>