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RecruitingNot ApplicableNCT06282497

Xerostomia-optimised IMRT Versus Standard IMRT in NPC

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

Sponsor

Zhongshan People's Hospital, Guangdong, China

Enrollment

524 participants

Start Date

Oct 23, 2023

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy

Summary

This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria8

  • 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 Criteria7

  • 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.

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Interventions

RADIATIONOptimised neck CTV

neck CTV delineation extends from the lateral process of C1

RADIATIONstandard neck CTV

neck CTV delineation extends from skull base

Locations(1)

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

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NCT06282497