MedTrace Logo

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

NCT07661771 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 568

Last updated 2026-07-28

No results posted yet for this study

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.

Conditions

  • Non-metastatic Nasopharyngeal Carcinoma

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).

RADIATION

IMRT 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

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jun Ma, Prof. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-24
Primary Completion
2029-07-30
Completion
2034-07-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07661771 on ClinicalTrials.gov