Reduced neck radiation for nasopharyngeal carcinoma

Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: a Multi-center, Non-inferiority, Open-label, Randomized Controlled Phase III Clinical Trial

This study is testing if giving less radiation to the neck can help people with nasopharyngeal carcinoma feel better and have fewer side effects compared to the usual treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 474 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 7 sites (Chongqing, Chongqing and 6 other locations)
• Trial ID: NCT05780372 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of reduced volume neck prophylactic radiotherapy compared to conventional methods in patients diagnosed with nasopharyngeal carcinoma without distant metastasis. It is a multi-center, open-label, randomized controlled phase III trial that aims to assess not only the efficacy of the treatment but also the associated adverse events and quality of life for participants. The study involves administering intensity-modulated radiation therapy and chemotherapy to eligible patients aged 18-70 with specific health criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 with a newly diagnosed nasopharyngeal non-keratinizing carcinoma and no prior treatment.

Not a fit: Patients with distant metastases or other malignant tumors will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to fewer side effects and improved quality of life for patients undergoing treatment for nasopharyngeal carcinoma.

How similar studies have performed: Other studies have explored similar approaches in radiotherapy, indicating potential for success, but this specific method is being tested for the first time in this context.

Eligibility criteria

Inclusion Criteria:

* Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
* All genders, range from 18-70 years old;
* ECOG score 0-1;
* Clinical stage I-IVa (AJCC/UICC 8th);
* Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
* No contraindications to chemotherapy or radiotherapy;
* Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase \< 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
* Sign the consent form.

Exclusion Criteria:

* Neck lymph nodes exist skipping metastasis;
* Distant metastases;
* Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
* Have or are suffering from other malignant tumors;
* Participating in other clinical trials;
* Pregnancy or lactation;
* Have uncontrolled cardiovascular disease;
* Severe complication, eg, uncontrolled hypertension;
* Mental disorder;
* Drug or alcohol addition;
* Do not have full capacity for civil acts.

Where this trial is running

Chongqing, Chongqing and 6 other locations

• Chongqing Cancer Hospital — Chongqing, Chongqing, China (NOT_YET_RECRUITING)
• Dongguan People Hospital — Dongguan, Guangdong, China (NOT_YET_RECRUITING)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)
• Liuzhou Worker's Hospital — Liuzhou, Guangxi, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (NOT_YET_RECRUITING)
• Jiangxi Cancer Hospital of Nanchang University — Nanchang, Jiangxi, China (NOT_YET_RECRUITING)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Chong Zhao, MD PhD — Sun Yat-sen University
• Study coordinator: Chong Zhao, MD PhD

Conditions: Nasopharyngeal Carcinoma, Radiotherapy, Complications