Study of second-generation 5-HT3-receptor antagonist; palonosetron for prevention of nausea and emesis in patients receiving chemotherapy including cisplatin for gastric cancer.

Not Applicable

• Conditions: Advanced gastric cancer

• Registration Number: JPRN-UMIN000009016
• Lead Sponsor: Digestive Disease Support Organization (DDSO)

Brief Summary

Complete response rate: 91.6% Complete protectionrate: 66.7%

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-01
• Study Completion: 2014-07-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

1) patients with serious hepatic insufficiency or renal failure. 2) patients with emesis within 24 hours before first administrating of cisplatin. 3) patients who were administered antiemetic drugs within 48 hours before first administrating of cisplatin. 4) patients with emetic factor except for chemotherapy 5) patient who was intended radiation therapy 6) patients judged inappropriate for this study by physicians. 7) patients who received Pimozide.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ratio of complete response (defined as no emesis and no rescue treatment). [Time Frame: overall; 0-120hr after chemotherapy, acute phase; 0-24hr, delayed phase; 24-120hr].

Secondary Outcome Measures

Name	Time	Method
1) ratio of patient without emesis. 2) ratio of patient without rescue treatment. 3) ratio of patient without nausea. 4) time to first emesis. 5) evaluation of volume of meal intake. 6) evaluation of QOL with Functional Living index-Emesis (FLIE) scale.