Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06095154
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-10-14
Brief Title:
CTV Delineation Based Solely on Geometric Expansion From GTV in Nasopharyngeal Carcinoma
Sponsor:
Fujian Cancer Hospital
Organization:
Fujian Cancer Hospital
Study Overview
Official Title:
CTV Delineation Based Solely on Geometric Expansion From GTV in Nasopharyngeal Carcinoma A Prospective Multi-center Randomized Controlled Phase III Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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 a randomized phase III prospective multi-center trial in newly diagnosed nasopharyngeal carcinoma NPC patients without distant metastasis The aim of this study is to evaluate the efficacy and safety of modified IMRT of which CTV delineation was only based on geometric expansion from GTV
Detailed Description:
All enrolled patients underwent intensity-modulated radiation therapy IMRT The IMRT technique was selected based on the equipment available at each treatment center and the patients preferences including IMRT VMAT or TOMOTHERAPY According to our study design all enrolled patients will be randomly assigned in a 11 ratio before radiation therapy The target area definitions are based on the international ICRU reports No 50 and No 60 The specific target area definitions and prescribed doses for the two groups are as follows
1 GTVp 70Gy33Fx Experimental Group Gross tumor as seen on imaging and nasopharyngoscopy Control Group Gross tumor as seen on imaging and nasopharyngoscopy
2 CTVp1 60Gy33Fx Experimental Group GTVp 5 mm Control Group GTVp 5 mm entire nasopharyngeal mucosa
3 CTVp2 54Gy33Fx Experimental Group GTVp 10 mm entire nasopharyngeal mucosa Control Group GTVp 10 mm high-risk anatomical structures
4 GTVn Experimental Group Lymph nodes as seen on imaging Control Group Lymph nodes as seen on imaging
5 CTVn Experimental Group Defined according to CACACMDA guidelines Control Group Defined according to CACACMDA guidelines
1 GTVp 70Gy33Fx Experimental Group Gross tumor as seen on imaging and nasopharyngoscopy Control Group Gross tumor as seen on imaging and nasopharyngoscopy
2 CTVp1 60Gy33Fx Experimental Group GTVp 5 mm Control Group GTVp 5 mm entire nasopharyngeal mucosa
3 CTVp2 54Gy33Fx Experimental Group GTVp 10 mm entire nasopharyngeal mucosa Control Group GTVp 10 mm high-risk anatomical structures
4 GTVn Experimental Group Lymph nodes as seen on imaging Control Group Lymph nodes as seen on imaging
5 CTVn Experimental Group Defined according to CACACMDA guidelines Control Group Defined according to CACACMDA guidelines
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