Comparing two types of radiotherapy for nasopharyngeal carcinoma

Xerostomia-optimised Intensity-modulated Radiotherapy Versus Standard Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma Patients:a Multicenter Non-inferior Randomized Controlled Phase III Clinical Trial

This study is testing if a special type of radiotherapy that protects the salivary glands can help people with nasopharyngeal cancer feel better and live longer compared to standard radiotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 524 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Zhongshan People's Hospital, Guangdong, China (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Zhongshan, Guangdong)
• Trial ID: NCT06282497 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multi-center, open-label, randomized controlled phase III trial that aims to evaluate the effectiveness of xerostomia-optimized intensity-modulated radiotherapy (IMRT) compared to standard IMRT in patients with newly diagnosed nasopharyngeal carcinoma (NPC) without distant metastasis. The study focuses on assessing regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) for participants. By optimizing the radiation dose to minimize exposure to the parotid glands, the trial seeks to reduce the incidence of xerostomia, a common side effect of radiation therapy. Participants will be randomly assigned to receive either the optimized or standard treatment approach.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 with a newly histologically diagnosed nasopharyngeal non-keratinizing carcinoma and an ECOG score of 0-1.

Not a fit: Patients with advanced nodal involvement or those who have previously received radiotherapy or chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce radiation-induced xerostomia in NPC patients, improving their quality of life.

How similar studies have performed: While this approach is based on existing knowledge of radiation therapy, the specific comparison of xerostomia-optimized IMRT versus standard IMRT in NPC is a novel investigation.

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 ≥ 90g/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:

* Level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 3cm in level II ;

  -≥4 nodal regions of ipsilateral neck involvement;
* Radiologically suspicious or confirmed involvement in level II area between skull base and the lateral process of C1;
* Parotid lymph node and/or parotid gland involvement;
* History of parotid disease or surgery;
* Previous malignancy or other concomitant malignant disease;
* Pregnancy or lactation.

Where this trial is running

Zhongshan, Guangdong

• Zhongshan City People's Hospital — Zhongshan, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Gui-qiong Xu, MD — Zhongshan People's Hospital, Guangdong, China
• Study coordinator: Gui-qiong Xu, MD

Conditions Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy