Optimizing radiation treatment for nasopharyngeal carcinoma

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

This study is testing two different radiation treatments for people with early to medium stage nasopharyngeal carcinoma to see which one works better and causes fewer side effects.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 414 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: ChineseAMS (unknown)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Beijing)
• Trial ID: NCT05145660 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare two radiation treatment strategies for patients with early to medium stage nasopharyngeal carcinoma (NPC). It will evaluate involved site irradiation (ISI), which targets only the affected lymph nodes, against the conventional elective region irradiation (ERI) that treats a broader area. The study will assess regional control, survival outcomes, radiation-related toxicities, and quality of life in a multicenter, randomized controlled format involving 488 patients. Participants will be assigned to either treatment group in a 1:1 ratio, with careful monitoring of their health and treatment responses.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with pathologically confirmed WHO type II-III nasopharyngeal carcinoma and specific TNM staging criteria.

Not a fit: Patients with advanced-stage NPC or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and less toxic radiation treatment options for patients with nasopharyngeal carcinoma.

How similar studies have performed: While involved site irradiation has shown promise in other malignancies, its effectiveness in nasopharyngeal carcinoma remains largely untested.

Eligibility criteria

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.

Where this trial is running

Beijing

• 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 (RECRUITING)

Study contacts

• Principal investigator: Junlin Yi — Chinese Academy of Medical Sciences
• Study coordinator: Junlin Yi, doctor

Conditions: Nasopharyngeal Carcinoma