Study of oral neurokinin-1 antagonist, aprepitant for the prevention of nausea and vomiting in patients receiving chemotherapy with irinotecan alone or combination of irinotecan plus cisplatin for unresectable gastric cancer

Study of oral neurokinin-1 antagonist, aprepitant for the prevention of nausea and vomiting in patients receiving chemotherapy with irinotecan alone or combination of irinotecan plus cisplatin for unresectable gastric cancer - Effect of aprepitant in patients receiving chemotherapy with irinotecan alone or combination of irinotecan plus cisplatin

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004021

Enrollment

Registered

2010-08-09

Start date

2010-08-01

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

gastric cancer

Interventions

1) Aprepitant: 125mg P.O./day on day1 followed by 80mg P.O./day on day2 and 3 2) Dexamethasone: 3.3mg I.V./body on day1-3 3) Granisetron: 40ug I.V./kg on day1 1) Placebo: Placebo capsules P.O. on d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologic diagnosis of gastric cancer 2) Possible state of oral intake 3) Unresectable gastric cancer 4) Performance status is 0 to 2 5) Patients who are older than 20 years at entry 6) WBC > 3,000/mm3, Platelets > 10,000/mm3 7) Patients who understand the study contents and give informed consents by themselves

Exclusion criteria

Exclusion criteria: 1) Known hypersensitivity to any component of study regimen 2) Patients receiving pimozide or atazanavir sulfate 3) Patients with active infectious diseases 4) Patients with active interstitial pneumonia or pulmonary fibrosis 5) Patients with large quantity of pleural effusion or ascites 6) Patients with frequent diarrhea (watery) 7) Patients with jaundice 8) Patients with ileus 9) Pregnant or lactating women 10) Patients who are regarded in-eligible by the doctor who participates in this study

Design outcomes

Primary

Measure	Time frame
1) Overall complete response (no vomiting and no rescue treatment) [Time Frame: During and post chemotherapy (0-120hr)] 2) Complete response acute/delayed phase [Time Frame: During and post chemotherapy (0-120hr)] 3) Overall complete protection (no vomiting, no rescue treatment and no significant nausea (VAS<25mm)) [Time Frame: During and post chemotherapy (0-120hr)] 4) Complete protection acute/delayed phase [Time Frame:During and post chemotherapy(0-120hr)]	—

Measure

Time frame

1) Overall complete response (no vomiting and no rescue treatment) [Time Frame: During and post chemotherapy (0-120hr)] 2) Complete response acute/delayed phase [Time Frame: During and post chemotherapy (0-120hr)] 3) Overall complete protection (no vomiting, no rescue treatment and no significant nausea (VAS<25mm)) [Time Frame: During and post chemotherapy (0-120hr)] 4) Complete protection acute/delayed phase [Time Frame:During and post chemotherapy(0-120hr)]

—

Secondary

Measure	Time frame
1) Proportion of patients without vomiting and nausea, frequency of vomiting, no rescue treatment, and time to first vomiting or first rescue treatment [Time Frame: During and post chemotherapy (0-120hr)] 2) Evaluation of nausea, vomiting and appetite loss using CTCAE, VAS scale and Functional Living index-Emesis (FLIE) scale[Time Frame: During and post chemotherapy (0-120hr)] 3) Investigation of potential factors predisposing patients to nausea and vomiting (e.g.,patient's sense of anxiety)	—

Measure

Time frame

1) Proportion of patients without vomiting and nausea, frequency of vomiting, no rescue treatment, and time to first vomiting or first rescue treatment [Time Frame: During and post chemotherapy (0-120hr)] 2) Evaluation of nausea, vomiting and appetite loss using CTCAE, VAS scale and Functional Living index-Emesis (FLIE) scale[Time Frame: During and post chemotherapy (0-120hr)] 3) Investigation of potential factors predisposing patients to nausea and vomiting (e.g.,patient's sense of anxiety)

—

Countries

Japan

Contacts

Public ContactJunji Tanaka

Hyogo College of Medicine Division of Upper Gastroenterology, Department of Internal Medicine

Outcome results

None listed

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