Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04201769
Status:
UNKNOWN
Last Update Posted:
2020-04-03
First Post:
2019-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexamethasone-sparing Approach Including NEPA Against Emesis Caused by Cisplatin
Sponsor:
Consorzio Oncotech
Organization:
Study Overview
Official Title:
A Standard Regimen of Dexamethasone in Comparison to Two Dex-sparing Regimens in Addition to NEPA in Preventing CINV in naïve NSCLC Patients to be Treated With Cisplatin Based Chemotherapy: a Three-arm, Open-label, Randomized Study
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUNG-NEPA
Brief 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
Detailed Description:
On day 1 (day of chemotherapy), all eligible patients will receive oral NEPA (300 mg netupitant/0.5 mg palonosetron), 60 minutes before chemotherapy, and intravenous dexamethasone 12 mg, 30 minutes before chemotherapy initiation.
For the prevention of delayed CINV, patients will be assigned randomly to one of the following treatment arms:
* Test arm A: no further anti-emetic prophylaxis on days 2 thorough 4;
* Test arm B: oral dexamethasone 4 mg once per day in the morning of days 2 and 3;
* Reference arm C: oral dexamethasone 4 mg twice per day on days 2 thorough 4.
For the prevention of delayed CINV, patients will be assigned randomly to one of the following treatment arms:
* Test arm A: no further anti-emetic prophylaxis on days 2 thorough 4;
* Test arm B: oral dexamethasone 4 mg once per day in the morning of days 2 and 3;
* Reference arm C: oral dexamethasone 4 mg twice per day on days 2 thorough 4.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: