Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-06-27 @ 3:33 AM
Study NCT ID:
NCT03637335
Status:
TERMINATED
Last Update Posted:
2018-08-20
First Post:
2018-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Palliative Radiotherapy With or Without Carboplatin
Sponsor:
Institut Cancerologie de l'Ouest
Organization:
Study Overview
Official Title:
Phase-3 Study, Randomized, Controlled, Multi-center, Double Blind, Comparing Palliative Radiotherapy With or Without Carboplatin
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped due to insufficient recruitment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
METAXIOM
Brief Summary:
The study population has locally advanced or metastatic bronchial or head and neck cancer.
This study assesses the value of concomitant chemo/radiotherapy with carboplatin daily during metastatic radiotherapy versus radiotherapy alone.
The realization of a systemic treatment during the radiotherapy could make it possible to obtain a benefit on the control of the evolution of the metastases and thus of the pains generated, as well as on the quality of life of the patients. In addition, a benefit in overall survival is possible.
This study assesses the value of concomitant chemo/radiotherapy with carboplatin daily during metastatic radiotherapy versus radiotherapy alone.
The realization of a systemic treatment during the radiotherapy could make it possible to obtain a benefit on the control of the evolution of the metastases and thus of the pains generated, as well as on the quality of life of the patients. In addition, a benefit in overall survival is possible.
Detailed Description:
The study population has locally advanced or metastatic bronchial or head and neck cancer.
Patients receive 10 injections of carboplatin (validated chemo-sensitizing molecule) or placebo (glucose) before 10 radiation sessions.
The overall duration is 14 days.
Patients receive 10 injections of carboplatin (validated chemo-sensitizing molecule) or placebo (glucose) before 10 radiation sessions.
The overall duration is 14 days.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: