A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by daily low-dose cisplatin-based concurrent chemoradiotherapy in patients with uterine cervical cancer.

A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by daily low-dose cisplatin-based concurrent chemoradiotherapy in patients with uterine cervical cancer. - A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by daily low-dose cisplatin-based concurrent chemoradiotherapy in patients with uterine cervical cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007638

Enrollment

Registered

2012-04-02

Start date

2012-04-01

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 x25) with daily low-dose cisplatin (8.0 mg/m2/day) Palonosetron (0.75 mg) as a single fixed intravenous dose 30 min be

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed uterine cervical cancer (squqmous cell carcinoma ,adenocarcinoma and adenosquamous cell carcinoma) 2) Clinical stage IB2-IVa patients who planned daily low-dose cisplatin-based concurrent chemoradiotherapy 3) Aged 20 years or more 4) ECOG Performance Status 0-2 5) Adequate bone-marrow function, renal function, liver function 6) Fully written informed consent.

Exclusion criteria

Exclusion criteria: 1) severe, uncontrolled, concurrent illness other than neoplasia; 2) asymptomatic metastases to the brain; 3) seizure disorder needing anticonvulsants unless clinically stable; 4) uncontrolled pleural effusion or ascites; 5) gastric outlet orintestinal obstruction; 6) any vomiting, retching, or grade 2or higher nausea according to CTCAE; 7) a known hypersensitivity to palonosetron, granisetron, or other 5-HT3-receptor antagonists or dexamethasone ingredients; 8) Between registration and administration of the study drug, patients who met the following discontinuation criteria were withdrawn from the study: appeared not to be eligible; received an antiemetic drug within 24 h before administration of study drug; and vomiting, retching, or grade 2 or higher nausea according to CTCAE within 24 h before administration of study drug.

Design outcomes

Primary

Measure	Time frame
The primary end point was the proportion of patients with a CR (no emesis and no rescue medication) during chemoradiothyeapy (day 1-35)	—

Secondary

Measure	Time frame
(i) proportion of patients with complete control (CC: no emetic episode, no rescue medication, and no more than mild nausea) during chemoradiothyeapy (day 1-35) (ii)CR rate and CC rate each of during day1~7, day8~14, day 15~21, day 22~28 and day 29~35 (iii) Overall patient satisfaction with antiemetic therapy was measured by a MASCC Antiemesis Tool (MAT) daily (iv) time to treatment failure (TTF: time to first emetic episode or first administration of rescue medication).	—

Measure

Time frame

(i) proportion of patients with complete control (CC: no emetic episode, no rescue medication, and no more than mild nausea) during chemoradiothyeapy (day 1-35) (ii)CR rate and CC rate each of during day1~7, day8~14, day 15~21, day 22~28 and day 29~35 (iii) Overall patient satisfaction with antiemetic therapy was measured by a MASCC Antiemesis Tool (MAT) daily (iv) time to treatment failure (TTF: time to first emetic episode or first administration of rescue medication).

—

Countries

Japan

Contacts

Public Contactakra 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