Ignite Creation Date:
2024-05-06 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03346109
Status:
UNKNOWN
Last Update Posted:
2022-04-06
First Post:
2017-11-15
Brief Title:
To Study the Feasibility and Quality of Life of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Prospective Randomised Controlled Non-inferior Trial Studying the Feasibility and Potential Quality of Life Benefits of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma
Status:
UNKNOWN
Status Verified Date:
2022-04
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:
None
Brief Summary:
This is an randomized controlled phase 3 clinical trial The purpose of this study is to evaluate whether medial group retropharyngeal node MRLN sparing could reduce the incidence of radiation-caused dysphagia and improve patients quality of life without compromising survival rate
Detailed Description:
In this study patients with non-keratinizing stage T1-4 N0-3 M0 NPCUICCAJCC 8th edition except for patients with MRLN metastasis are randomly assigned to receive MRLN sparing or prophylactic irradiation Patients in MRLN sparing group will not routinely receive MRLN irradiation to 56Gy33Fr while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy33Fr Our primary endpoint is local relapse-free survival LRFS Secondary end points include overall survival OS incidence of out-field recurrence rate toxic effects and quality of life QOLAll efficacy analyses are conducted in the intention-to treat population and the safety population include only patients who receive their randomly assigned treatment
Study Oversight
Has Oversight DMC:
None
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?:
None