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Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma
Sponsor: Sun Yat-sen University
Summary
This is a non-inferiority, multicenter, randomized phase 3 trial aimed to evaluate whether primary clinical target volume (CTVp) delineation based on margin expansion provides comparable outcomes compared with the consensus CTVp approach based on margin expansion and the stepwise extension pattern in newly diagnosed non-metastatic nasopharyngeal carcinoma.
Official title: Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma: A Non-Inferiority, Multicenter, Randomized Phase 3 Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
568
Start Date
2026-07-24
Completion Date
2034-07-30
Last Updated
2026-08-19
Healthy Volunteers
No
Conditions
Interventions
Comprehensive Therapy Based on Tumor Stage
1. T1N0: Radiotherapy Only. 2. T1N1, T2N0-1, T3N0: Radiotherapy with or without Concurrent Chemotherapy (Cisplatin). 3. T3N1, T4N0: Concurrent Chemoradiotherapy (Cisplatin) with or without Induction Chemotherapy (GP Regimen). 4. T1-4N2-3, T4N1: ① Induction Chemotherapy (GP Regimen) + Concurrent Chemoradiotherapy (Cisplatin); ② Induction Chemoimmunotherapy (GP Regimen + PD-1 Monoclonal Antibody) + Concurrent Chemoradiotherapy (Cisplatin) + Adjuvant Immunotherapy (PD-1 Monoclonal Antibody); ③ Induction Chemotherapy (GP Regimen) + Concurrent Chemoradiotherapy (Cisplatin) + Adjuvant Immunotherapy (PD-1 Monoclonal Antibody).
IMRT with Primary Clinical Target Volume Based on Margin Expansion
1. Target delineation: 1. CTVp\_High = GTVp + 0 mm; 2. CTVp\_Mid = CTVp\_High + 5 mm; 3. CTVp\_Low = CTVp\_Mid + 5 mm + whole nasopharynx; 4. CTVn\_High = GTVn + 0 mm; 5. CTVn\_Mid = CTVn\_High + 3-5 mm (for nodes with imaging-detected extranodal extension) or 0 mm (for nodes without imaging-detected extranodal extension) + equivocal nodes in the anticipated drainage levels, close proximity to enlarged nodes, or with suspicious PET results; 6. CTVn\_Low = CTVn\_Mid + 3 mm + elective drainage levels. 2. Dose prescription: 1. 6996 cGy/33 fx for CTVp\_High and CTVn\_High; 2. 6006 cGy/33 fx for CTVp\_Mid and CTVn\_Mid; 3. 5412 cGy/33 fx for CTVp\_Low and CTVn\_Low.
IMRT with Consensus Primary Clinical Target Volume
1. Target delineation: 1. CTVp\_High = GTVp + 0 mm; 2. CTVp\_Mid = CTVp\_High + 5 mm; 3. CTVp\_Low = CTVp\_Mid + 5 mm + whole nasopharynx + high-risk structures based on stepwise local extension patterns of tumor spread; 4. CTVn\_High = GTVn + 0 mm; 5. CTVn\_Mid = CTVn\_High + 3-5 mm (for nodes with imaging-detected extranodal extension) or 0 mm (for nodes without imaging-detected extranodal extension) + equivocal nodes in the anticipated drainage levels, close proximity to enlarged nodes, or with suspicious PET results; 6. CTVn\_Low = CTVn\_Mid + 3 mm + elective drainage levels; 2. Dose prescription: 1. 6996 cGy/33 fx for CTVp\_High and CTVn\_High; 2. 6006 cGy/33 fx for CTVp\_Mid and CTVn\_Mid; 3. 5412 cGy/33 fx for CTVp\_Low and CTVn\_Low.
Locations (7)
Dongguan People's Hospital
Dongguan, Guangdong, China
First People's Hospital of Foshan
Foshan, Guangdong, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China