Palonosetron in combination with 1-day versus 3-day dexamethason for prevention of nausea and vomiting following paclitaxel and carboplatin for gynecologic cancer: a randomized, multicenter, phase 2 trial

Palonosetron in combination with 1-day versus 3-day dexamethason for prevention of nausea and vomiting following paclitaxel and carboplatin for gynecologic cancer: a randomized, multicenter, phase 2 trial - Palonosetron in combination with 1-day versus 3-day dexamethason for prevention of nausea and vomiting following paclitaxel and carboplatin for gynecologic cancer: a randomized, multicenter, phase 2 trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009215

Enrollment

110

Registered

2012-11-01

Start date

2012-11-01

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, endometrial cancer, ovarian cancer

Interventions

Palonosetoron + dexamethasone day 1-3 Palonosetoron + dexamethasone day 1

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Patients of age =>20 2)Diagnosis of cervical cancer, endometrial cancer, ovarian cancer 3)No history of systemic chemotherapy 4)receiving carboplatin and paclitaxel (TC) chemotherapy. The following treatment is planned. Conventional TC: Paclitaxel 175mg/m2 (day1) + Carboplatin AUC6 (day1) Dose dense TC: Paclitaxel 80mg/m2 (day1, 8, 15) + Carboplatin AUC6 (day1) 5)Adequate bone-marrow function, renal function, liver function 6)Performance status: 0-1 (ECOG) 7)Written informed consent

Exclusion criteria

Exclusion criteria: They had serious complication. No known CNS metastasis Patients who has a convulsive disorders that need anticonvulsants therapy They had ascites or pleural effusion needs paracentesis treatment Patients with obstruction of gastrointestinal tract,for example gastric outlet or ileus Patients with vomiting or nausea (>= Grade2) Hypersensitivity or severe drug allergy for 5-HT3RA Hypersensitivity or severe drug allergy for dexamethasone Pregnant, breastfeeding or expecting woman Patients with a history of palonosetron Without the capability or the intention of cooperating Participated in other anti-emetic clinical trial Patients judged inappropriate for this study by physicians

Design outcomes

Primary

Measure	Time frame
Percentage of patients with complete response (no vomiting and no rescue medication use) during the 120 hours observation period after the infusion of chemotherapy.	—

Secondary

Measure	Time frame
(1) Complete response rate during acute phase (0-24hr) and delayed phase (24-120hr). (2)Complete control rate during acute phase (0-24hr) and delayed phase (24-120hr). (3) Adverse events defined on CTCAE ver 4.0	—

Countries

Japan

Contacts

Public ContactMotoki Matsuura

Nikko Memorial Hospital Gynecology

motoki.gyne@gmail.com

Outcome results

None listed

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