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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005551

Enrollment

Registered

2011-06-01

Start date

2011-01-01

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

1. 5-FU plus cisplatin Cisplatin is administered at a dose of 80 mg/m2 by slow drip infusion for 2h on day 1, and 5-FU is administered at a dose of 800 mg/m2 per day by continuous infusion for 24 h o

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed esophageal carcinoma 2. Patients who receive chemotherapy consists of 5-FU plus cisplatin 3. ECOG performance status of 0-2 4. Adequate organ function 5. Sufficient oral intake 6. Written informed consent

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Primary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactAyumu Hosokawa

University of Toyama Department of Gastroenterology and Hematology, Faculty of Medicine

ayhosoka@med.u-toyama.ac.jp076-434-7301

Outcome results

None listed

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