A phase II study of Palonosetron combined with Dexamethasone and Aprepitant to prevent nausea and vomiting in patients receiving highly emetogenic chemotherapy for esophageal cancer

A phase II study of Palonosetron combined with Dexamethasone and Aprepitant to prevent nausea and vomiting in patients receiving highly emetogenic chemotherapy for esophageal cancer - A phase II study of Palonosetron, Dexamethasone and Aprepitant in patients receiving chemotherapy for esophageal cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005017

Enrollment

Registered

2011-02-03

Start date

2011-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer

Interventions

Aprepitant is administered orally at 125 mg/body 1 hour before Cisplatin administration. On day 2 and 3, Aprepitant is administrated orally or through a gastrostomy tube at 80 mg/body. Palonosetron 0

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) age: >=20 2) histologically or cytologically confirmed esophageal cancer 3) chemotherapy na&iuml;ve patients who are scheduled to receive high emetogenic chemotherapy (5-FU/CDDP) 4) sufficient function of important organs a)WBC: >=3,000/mm3 b)AST: <100 IU/L c)ALT: <100 IU.L d)Ccr: >=60 ml/min/body 5) Performance Statues: 0-1(ECOG) 6) written informed consent

Exclusion criteria

Exclusion criteria: 1) with seizure disorder needing anticonvulsants unless clinically stable 2) with vomiting, retching, or grade 2 or higher nausea according to CTCAE 3) with severe allergy to Palonosetron, Aprepitant and Dexamethasone 4) pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant 5) receiving an antiemetic drug 6) receiving pimozide (orap) 7) with history of mental disorder or treating it at the moment 8) doctor's decision not to be registered to this study

Design outcomes

Primary

Measure	Time frame
the proportion of patients with a Complete Response during the acute phase (0&#8211;24 h postchemotherapy) and the delayed phase (24&#8211;120 h postchemotherapy) and the overall phase(0&#8211;120 h postchemotherapy)	—

Secondary

Measure	Time frame
1) the proportion of patients with a Complete Control during the acute phase (0&#8211;24 h postchemotherapy) and the delayed phase (24&#8211;120 h postchemotherapy) and the overall phase(0&#8211;120 h postchemotherapy) 2) the proportion of patients without nausea during the acute phase (0&#8211;24 h postchemotherapy) and the delayed phase (24&#8211;120 h postchemotherapy) and the overall phase(0&#8211;120 h postchemotherapy) 4)safety	—

Measure

Time frame

1) the proportion of patients with a Complete Control during the acute phase (0&#8211;24 h postchemotherapy) and the delayed phase (24&#8211;120 h postchemotherapy) and the overall phase(0&#8211;120 h postchemotherapy) 2) the proportion of patients without nausea during the acute phase (0&#8211;24 h postchemotherapy) and the delayed phase (24&#8211;120 h postchemotherapy) and the overall phase(0&#8211;120 h postchemotherapy) 4)safety

—

Countries

Japan

Contacts

Public ContactYasushi Ichikawa

Yokohama City University Graduate School of Medicine Department of Clinical Oncology

045-787-2623

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026