Optimization of Cervical Nodal CTV for Early and Medium Stage NPC

NCT05145660 · tracked via the Priya Life Science China tracker

Sponsor

Yi Junlin

Phase

Phase 3

Started

2022-09-01

Last updated

2026-05-28

Condition(s) studied

Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

intensity-modulated radiotherapy (IMRT) with reduced-volumeChemotherapy

intensity-modulated radiotherapy (IMRT) with reduced-volume: PGTVnx: 69.9Gy/2.12Gy/33f GTVrpn: 69.9Gy/2.12Gy/33f GTVnd: 69.9Gy/2.12Gy/33f GTVnd-suspicious: 60.06Gy/1.82Gy/33f PTV1: 60.06Gy/1.82Gy/33f PTV2: 50.96Gy/1.82Gy/28f

Chemotherapy: Concurrent cisplatin (100 mg/m², d1-3, Q3w, maximum to three cycles); The application of induction chemotherapy and consolidation chemotherapy is dependent on the physician's discretion.

Study summary

Current radiotherapy guidelines and consensus statements uniformly recommend elective region irradiation (ERI) as the standard strategy for nasopharyngeal carcinoma (NPC). However, given the scarcity of skip-metastasis, the improved assessment accuracy of nodal involvement, and the striking advancements in chemotherapy for NPC, a one-fits-all delineation scheme for clinical target volumes for the nodal region (CTVn) may not be appropriate anymore, and modifications of the CTVn delineation strategy may be warranted. Involved site irradiation (ISI) covering merely the initially involved nodal site and potential extranodal extension has been confirmed to be as effective as ERI with decreased radiation-related toxicities in some malignancies, but has not yet been investigated in NPC. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of ISI with conventional ERI in NPC patients with a limited nodal burden.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Accepted

1. Age between 18 and 75 years; 2. Karnofsky performance status (KPS) score ≥ 70; 3. Pathologically confirmed World Health Organization (WHO) type II-III NPC; 4. TNM stage I-III (T1-3N0-2M0) according to the 8th American Joint Committee on Cancer / Union for International Cancer Control (AJCC/UICC) staging system with a maximum diameter (MAD) of cervical involved LNs ≤ 3 cm, namely LB-LN; 5. Available baseline nasopharynx and neck computed tomography (CT) or magnetic resonance imaging (MRI) (strongly advocated) data (including functional MRI sequences) and measurable tumor lesions; 6. All procedures for defining the tumor burden completed within 4 weeks of registration; 7. Survival expectancy of at least 6 months; 8. Normal marrow and organ function: hemoglobin ≥ 120 g/L, WBCs ≥ 4 × 109 /L, platelets ≥ 100 × 109 /L; liver and kidney function-related indicators within 1.25\*the normal upper limit; 9. Patient willingness to comply with the protocol; 10. Patient willingness and ability to provide an informed consent form.

Primary outcome measure(s)

Regional-recurrence-free survival — 3-year
measured from the registration to the documented regional recurrence

Trial sites (1)

Facility	City	Region	Status
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)	Beijing	China

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Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma Recruiting

Maintenance Therapy With Toripalimab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma Active, not recruiting

Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma Recruiting

Adebrelimab and Chemoradiotherapy in High-risk LANPC Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05145660 on ClinicalTrials.gov ↗ ← All trials in China