Phase III study to clarify the efficacy and safety of aprepitant or palonosetron on chemotherapy with paclitaxel and carboplatin for gynecologic cancer

Phase III study to clarify the efficacy and safety of aprepitant or palonosetron on chemotherapy with paclitaxel and carboplatin for gynecologic cancer - Phase III study to clarify the efficacy and safety of aprepitant or palonosetron on chemotherapy with paclitaxel and carboplatin for gynecologic cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009585

Enrollment

100

Registered

2013-03-01

Start date

2013-03-01

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

Cervical cancer, Corpus cancer, Ovarian cancer, Tubal cancer, Peritoneal cancer

Interventions

Aprepitant and granisetron and dexamethasone Palonosetron and dexamethasone

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Gynecologic cancer patients necessary the chemotherapy with paclitaxel and carboplatin

Exclusion criteria

Exclusion criteria: 1. Past history of previous chemotherapy 2. Hypersensitivity for Aprepitant or Palonosetron

Design outcomes

Primary

Measure	Time frame
Anti emetic efficacy for 5 days after chemotherapy	—

Secondary

Measure	Time frame
1. Anti emetic efficacy on the day of chemotherapy 2. Anti-emetic efficacy during day2 to 5 after chemotherapy 3. Ratio of emesis, vomiting and rescue therapy for 5 days after chemotherapy 4. Time until rescue therapy 5. Food intake after chemotherapy 6. Influence of risk factor (Background of patient) 7. Total amount for anti emetic therapy 8. Influence by difference of the schedule of carboplatin and Paclitaxel 9. Change the efficacy on several courses 10. Efficacy of rescue therapy with aprepitant or palonosetron	—

Measure

Time frame

1. Anti emetic efficacy on the day of chemotherapy 2. Anti-emetic efficacy during day2 to 5 after chemotherapy 3. Ratio of emesis, vomiting and rescue therapy for 5 days after chemotherapy 4. Time until rescue therapy 5. Food intake after chemotherapy 6. Influence of risk factor (Background of patient) 7. Total amount for anti emetic therapy 8. Influence by difference of the schedule of carboplatin and Paclitaxel 9. Change the efficacy on several courses 10. Efficacy of rescue therapy with aprepitant or palonosetron

—

Countries

Japan

Contacts

Public ContactMasato Nishimura

Tokushima University Hospital Obstetrics and Gynecology

088-633-7177

Outcome results

None listed

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