CTV Delineation Based Solely on Geometric Expansion From GTV in Nasopharyngeal Carcinoma: A Prospective, Multi-center, Randomized Controlled Phase III Clinical Study
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
• No distant metastatic;
• Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital;
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
• Signing informed consent;
• Follow up regularly and comply with test requirements.
Locations
Other Locations
China
Fujian Cancer hospital
RECRUITING
Fuzhou
Contact Information
Primary
Shaojun Lin, DR
linshaojun@yeah.net
13860603879
Backup
Qiaojuan Guo, DR
guoqiaojuan163@.com
15080013157
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 474
Treatments
Experimental: Experimental Group
GTVp (70Gy/33Fx): Gross tumor as seen on imaging and nasopharyngoscopy. CTVp1 (60Gy/33Fx): None. CTVp2 (54Gy/33Fx): GTVp + 10 mm + entire nasopharyngeal mucosa. GTVn: Lymph nodes as seen on imaging. CTVn: Defined according to CACA/CMDA guidelines.
No_intervention: Control Group
GTVp (70Gy/33Fx): Gross tumor as seen on imaging and nasopharyngoscopy. CTVp1 (60Gy/33Fx): GTVp + 5 mm + entire nasopharyngeal mucosa. CTVp2 (54Gy/33Fx): GTVp + 10 mm + high-risk anatomical structures. GTVn: Lymph nodes as seen on imaging. CTVn: Defined according to CACA/CMDA guidelines.
Related Therapeutic Areas
Sponsors
Leads: Fujian Cancer Hospital