Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy
Conditions
Brief 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
Detailed description
Xerostomia remains one of the most common radiation-induced toxicities, and approximately 80% to 90% of NPC patients still experience varying degrees of xerostomia post-IMRT. Among the major salivary glands, the parotid gland is the largest and produces 60% to 65% of the oral saliva output. Studies have revealed that xerostomia post-IMRT is mainly dependent on the irradiation dose of the parotid glands. Clinical target volumes (CTV) for the cervical nodal region starting from skull base have been the standard in nasopharyngeal carcinoma for several decades. Consequently, the parotid glands overlap with the target volumes and irradiation dose reaches 31.7 Gy to 43.9 Gy in most reports. Retrospective studies reveal that the lateral process of C1 is a suitable cranial edge for neck CTV delineation; therefore, the volume of the parotid glands exposed to high radiation doses can be greatly reduced. we conducted this trial comparing outcomes ,toxicities and QoL of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in nasopharyngeal carcinoma.
Interventions
RADIATIONOptimised neck CTV
neck CTV delineation extends from the lateral process of C1
RADIATIONstandard neck CTV
neck CTV delineation extends from skull base
Sponsors
Zhongshan People's Hospital, Guangdong, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regional recurrence free survival | 3 years | From the date of randomization to regional recurrence or any death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence free survival | 3 years | From the date of randomization to local recurrence or any death |
| Distant metastasis-free survival | 3 years | From the date of randomization to distant metastasis or any death |
| Overall survival | 3 years | From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up |
| Acute toxicities | From the start of treatment until 3 months post treatment | Assessed with CTCAE v5.0 |
| Late toxicities | 3 years post treatment | Assessed with Radiation Therapy Oncology Group criteria and the CTCAE v5.0 |
| Progression free survival | 3 years | From the date of randomization to local or regional recurrence, distant metastasis or any death |
Countries
China
Contacts
Primary ContactGui-qiong Xu, MD
Outcome results
None listed