RecruitingPhase 3NCT07661771

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

Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma: A Non-Inferiority, Multicenter, Randomized Phase 3 Trial

Sponsor

Sun Yat-sen University

Enrollment

568 participants

Start Date

Jul 24, 2026

Study Type

INTERVENTIONAL

Conditions

Non-metastatic Nasopharyngeal Carcinoma

Summary

This is a non-inferiority, multicenter, randomized phase 3 trial aimed at investigating the impact of individualized primary clinical target volume based on margin expansion on patients' prognosis and complications compared with the consensus primary clinical target volume based on margin expansion and stepwise extension pattern for patients with newly diagnosed non-metastatic nasopharyngeal carcinoma.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Comprehensive Therapy Based on Tumor Stage, IMRT with Consensus Primary Clinical Target Volume, and others for people with non-metastatic nasopharyngeal carcinoma. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREComprehensive 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).

RADIATIONIMRT with Individualized 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

RADIATIONIMRT 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(5)

Dongguan People's Hospital

Dongguan, Guangdong, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, Guangdong, China

Hunan Cancer Hospital

Changsha, Hunan, China

Xiangya Hospital Central South University

Changsha, Hunan, China

View Full Details on ClinicalTrials.gov

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NCT07661771