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Dexamethasone-sparing Approach Including NEPA Against Emesis Caused by Cisplatin

NCT04201769 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2020-04-03

No results posted yet for this study

Summary

This study evaluates the possibility to reduce the total dose of dexamethasone, when administered with NEPA, to prevent chemotherapy-induced nausea and vomiting (CINV) in Non-Small Cell Lung Cancer (NSCLC) patients receiving a cisplatin-based chemotherapy

Conditions

  • Chemotherapy-induced Nausea and Vomiting

Interventions

DRUG

Netupitant/Palonosetron

NEPA is adiministered 60 minutes before chemotherapy, on day 1

DRUG

Dexamethasone

Intravenous dexamethasone 12 mg is administered 30 minutes before chemotherapy initiation, on day 1. The administration of DEX in the subsequent days (2-4) depends on the randomly assignement to treatment arm

Sponsors & Collaborators

  • Consorzio Oncotech

    lead OTHER

Principal Investigators

  • Emilio Bria, MD · Fondazione Policlinico Universitario "A. Gemelli" IRCCS, UCSC - Rome (Italy)

  • Luigi Celio, MD · Fondazione IRCCS "Istituto Nazionale Tumori" - Milan (Italy)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-25
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT04201769 on ClinicalTrials.gov