Preventive effect of combination therapy with aprepitant, palonosetron and dexamethasone on chemotherapy-induced nausea and vomiting (CINV) in esophageal cancer patients receiving 5-FU plus cisplatin: a prospective phase II study

Phase 2

• Conditions: Esophageal cancer

• Registration Number: JPRN-UMIN000005551
• Lead Sponsor: niversity of Toyama

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1. Severe complications (intestinal paralysis, symptomatic cardiovascular disease, pulmonary fibrosis, uncontrollable diabetes mellitus, active peptic ulcer, psychiatric disorder, cerebrovascular disorder) 2. Brain metastasis 3. Seizure disorder needing anticonvulsants 4. Massive ascites or pleural effusion 5. Intestinal obstruction 6. Vomiting, or grade 2 or higher nausea according to CTCAE ver4.0 7. QTc>470msec (examined within 28 days before registration) 8. Hypersensitivity or severe drug allergy to aprepitant, palonosetron or other 5-HT3-receptor antagonists 9. Hypersensitivity or severe drug allergy to dexamethasone 10. Pregnant or breast-feeding woman 11. Men of wishing fertility 12. Administration of pimozide 13. Not appropriate for the study at the physician's assessment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with a complete response (defined as no vomiting and no rescue medication) during the delayed phase after administration of 5-FU plus cisplatin

Secondary Outcome Measures

Name	Time	Method
1. The proportion of patients with a complete response during the acute phase and overall phases after administration of 5-FU plus cisplatin 2. The proportion of patients with a complete control (defined as no vomiting, no rescue medication, and no more than mild nausea) during the acute phase, the delayed phase and overall phases 3. The degree of nausea during the acute phase, the delayed phase and overall phases 4. Safety