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The Optimization of Antiemetic Regimen for C-RINV in LA-HNSCCs

NCT05202275 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2022-01-21

No results posted yet for this study

Summary

This study sought to investigate the efficacy and safety of a three-drug combination antiemetic regimen of olanzapine combined with aprepitant and palonosetron for the prevention of chemoradiotherapy-induced nausea and vomiting in locally advanced head and neck squamous cell carcinoma.

Conditions

Interventions

DRUG

Olanzapine

Intensity-modulated radiotherapy was given to the patients with regimen of 69.96 Gy-73.92 Gy to the gross target volume of nasopharynx, 69.96 Gy to the gross target volume of positive nodes, 60.06 Gy the high risk clinical target volume, 50.96 Gy to the low risk clinical target volume. Concurrent chemotherapy is administrated with cisplatin 100mg/m2 at d1, d22, d43 during radiotherapy. All patients were given orally olanzapine 10mg once on d1-5; intravenously palonosetron 0.25mg once on d1; aprepitant 125 mg once on d1, then 80mg once on d2-5 at every chemotherapy cycle.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Ye Zhang, MD · National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-12-31
Completion
2023-09-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05202275 on ClinicalTrials.gov