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.

Not Applicable

• Conditions: cervical cancer

• Registration Number: JPRN-UMIN000007638
• Lead Sponsor: chiba university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

Not provided

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Between registration and administration of the study drug, patients who met the following discontinuation criteria were withdrawn from the study: appeared not to be eligible; received an antiemetic drug within 24 h before administration of study drug; and vomiting, retching, or grade 2 or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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
(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).