Comparing two types of radiotherapy for nasopharyngeal carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: donna_shee@163.com
• Phone: +8613528109888

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.