Efficacy of palonosetron plus aprepitant in preventing chemoradiotherapy-induced nausea and emesis in patients receiving daily low-dose cisplatin-based concurrent chemoradiotherapy for uterine cervical cancer: a phase II study

Efficacy of palonosetron plus aprepitant in preventing chemoradiotherapy-induced nausea and emesis in patients receiving daily low-dose cisplatin-based concurrent chemoradiotherapy for uterine cervical cancer: a phase II study - Efficacy of palonosetron plus aprepitant in preventing chemoradiotherapy-induced nausea and emesis in patients receiving daily low-dose cisplatin-based concurrent chemoradiotherapy for uterine cervical cancer: a phase II study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011616

Enrollment

Registered

2013-09-02

Start date

2013-07-01

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

Interventions

The daily chemoradiation comprised pelvic external beam radiotherapy (2 Gy/day, 25 fractions, five times a week) with daily low-dose cisplatin (8 mg/m2/day). All eligible patients received aprepitant

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: i) histologically confirmed uterine cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma) ii) those with clinical stage IB2-IVa cancer in whom daily low-dose cisplatin-based concurrent chemoradiotherapy was planned as primary and adjuvant treatments iii) no prior chemotherapy or radiotherapy iv) age over 20 years with an Eastern Cooperative Oncology Group performance status of 0-2 v) adequate bone marrow, renal, and liver functions.

Exclusion criteria

Exclusion criteria: i) severe systemic or uncontrolled disease (uncontrolled diabetes mellitus or hypertension) ii) asymptomatic metastases to the brain iii) seizure disorder requiring anticonvulsants unless clinically stable iv) uncontrolled pleural effusion or ascites v) gastric outlet or intestinal obstruction vi) a known hypersensitivity to palonosetron, granisetron, or other 5-HT3-receptor antagonists or dexamethasone ingredients. In the period between registration of patients and administration of the study drug, patients who met the following discontinuation criteria were withdrawn from the study

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoints of this study were proportion of patients with complete response (defined as no emetic episodes and no rescue medication) during the overall phase.	—

Secondary

Measure	Time frame
The secondary endpoints were complete control (defined as no emetic episodes, no rescue medication, and no more than mild nausea), the number of emetic episodes, severity of nausea, adverse effect, time to administration of rescue therapy, and total dose of rescue dexamethasone.	—

Countries

Japan

Contacts

Public ContactAkira Mitsuhashi

Graduate School of Medicine, Chiba University Reproductive Medicine

antira@faculty.chbia-u.jp043-222-7171

Outcome results

None listed

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