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RECRUITING
NCT07661771
PHASE3

Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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).

RADIATION

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.

RADIATION

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