RECRUITINGPhase 3INTERVENTIONAL

Optimization of Cervical Nodal CTV for Early and Medium Stage NPC

Optimization of Cervical Nodal Clinical Tumor Volume for Early and Medium Stage Nasopharyngeal Carcinoma: a Multicenter Non-inferior Randomized Controlled Phase III Clinical Trial

About This Trial

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.

Who May Be Eligible (Plain English)

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: blood count (hemoglobin) at least 120 g/L, WBCs ≥ 4 × 109 /L, platelet count at least 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 willing to sign a consent form form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

RADIATION

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

DRUG

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.

Locations (1)

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