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Aprepitant, Palonosetron and Dexamethasone Antiemetic Therapy Evaluation trial in germ cell tumor (APDATE)

Aprepitant, Palonosetron and Dexamethasone Antiemetic Therapy Evaluation trial in germ cell tumor (APDATE) - Antiemetic therapy in germ cell tumor

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008110
Enrollment
30
Registered
2012-06-05
Start date
2012-06-01
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

Germ cell tumor

Interventions

Aprepitant, palonosetron and dexamethasone

Sponsors

Department of Urology, Sapporo Medical University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Germ cell tumor 2. Receiving BLM/ETP/CDDP chemotherapy 3. No history of systemic chemotherapy 4. Sufficient organ functions 5. Ability of oral intake 6. ECOG PS 0-2 7. Informed consent

Exclusion criteria

Exclusion criteria: 1. Uncontrollable complications 2. Brain metastasis 3. Active convulsive disease 4. Plural effusion or ascites requiring puncture 5. Obstruction of the gastric outlet or ileus 6. Vomiting or severe nausea before the chemotherapy 7. Anaphylaxis against 5-HT3 receptor inhibitors, aprepitant or dexamethasone 8. Disapproval of contraception 9. History og aprepitant or palonostron 10. Participation of other clinical trials of antiemetics

Design outcomes

Primary

MeasureTime frame
Complete response

Secondary

MeasureTime frame
Conplete control (no emetic episodes, no rescue medication use and no more than mild nausea), adverse events

Countries

Japan

Contacts

Public ContactFumimasa Fukuta

Sapporo Medical University School of Medicine Department of Urology

uroikai@sapmed.ac.jp81-11-611-2111

Outcome results

None listed

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