Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma

Launched by SUN YAT-SEN UNIVERSITY · Mar 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating nasopharyngeal carcinoma, a type of cancer that affects the area behind the nose and throat. The researchers want to find out if giving less radiation to the neck area (known as neck prophylactic radiotherapy) is just as effective as the standard treatment, while also looking at any side effects and how it affects the quality of life for patients. The trial is open to adults aged 18 to 70 who have recently been diagnosed with a specific type of nasopharyngeal carcinoma, have not received any previous cancer treatments, and meet certain health criteria.

Participants in the trial can expect to be randomly assigned to either the reduced radiation group or the standard radiation group. Throughout the study, they will be monitored for any side effects and will also provide feedback on their quality of life. It's important to note that individuals with certain conditions, such as distant cancer spread or serious health issues, won't be eligible to participate. This trial aims to improve treatment for nasopharyngeal carcinoma while minimizing complications for patients.

Gender

ALL

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.