Nasopharyngeal Cancinoma (NPC)
Conditions
Keywords
nasopharyngeal carcinoma, radiotherapy
Brief summary
This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture.
Detailed description
This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture. The enrolled patients will be 1:1 randomly assigned to receive reduced CTV delineation radiotherapy (anterior border of CTV2 defined as 5 mm anterior to the choanae), or standard CTV delineation radiotherapy (anterior border of CTV2 defined as the posterior 1/3 of the nasal cavity).
Interventions
RADIATIONstandard CTV delineation
The anterior border of CTV2 is delineated at the posterior 1/3 of the nasal cavity.
RADIATIONreduced CTV delineation
The anterior border of CTV2 is defined as 5 mm anterior to the posterior nasal cavity anteriorly from the choanae.
Sponsors
First People's Hospital of Foshan
Affiliated Hospital of Guangdong Medical University
The Wuzhou Red Cross Hospital
The Fourth Affiliated Hospital of Guangxi Medical University
Zhongshan City People 's Hospital
Hai-Qiang Mai,MD,PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Newly diagnosed, histologically confirmed non-keratinizing carcinoma (WHO classification). 2. Stage I-III disease (AJCC 9th edition). 3. Tumor extends to nasal cavity (including nasal septum). 4. No distant metastasis (M0). 5. Age 18-70 years. 6. Male or non-pregnant female. 7. Scheduled for radiotherapy. 8. ECOG performance status 0-1 . 9. Adequate bone marrow function: white blood cells \>4×10⁹/L, hemoglobin \>90 g/L, platelets \>100×10⁹/L. 10. Normal hepatic/renal function: total bilirubin ≤1.5×ULN, AST/ALT ≤2.5×ULN, alkaline phosphatase ≤2.5×ULN, creatinine clearance ≥60 mL/min. 11. Written informed consent obtained.
Exclusion criteria
1. Keratinizing squamous cell carcinoma (WHO Type I) or basaloid squamous cell carcinoma. 2. Age \<18 or \>70 years. 3. Recurrent disease or distant metastasis. 4. No tumor extension into the nasal cavity (including the nasal septum). 5. Prior malignancy (except adequately treated basal/squamous cell skin cancer or cervical carcinoma in situ). 6. Pregnancy/lactation (premenopausal women require pregnancy test; effective contraception mandated). 7. Prior radiotherapy (except non-melanoma skin cancer with lesions outside current portals). 8. Preoperative chemotherapy or surgical resection of primary/neck lesions (excluding diagnostic procedures). 9. Severe coexisting illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local relapse-free survival | 3 year | The time from randomization to documented local relapse or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant metastasis-free survival | 3 year | The time from randomization to distant metastasis or death from any cause. |
| Regional relapse-free survival | 3 year | The time from randomization to documented regional relapse or death from any cause. |
| Incidence rate of adverse events (AEs) | 2 year | Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme. |
| Change of quality of life | 1 year | Quality of life scores were assessed for each scale by using the 22-item Sino-Nasal Outcome Test (SNOT-22) before radiotherapy, at the end of radiotherapy, and at the 3, 6, 12 month after radiotherapy. |
| Overall survival | 3 year | The time from randomization to death from any cause or censored at the date of the last follow-up. |
| Progression-free survival | 3 year | The time from randomization to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occur first. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of radiation-induced sinusitis | 1 year | Radiation-induced sinusitis was assessed by head and neck enhanced magnetic resonance imaging (MRI) before radiotherapy, at the end of radiotherapy, and at 3, 6, and 12 months after radiotherapy. |
| Incidence of olfactory dysfunction | 1 year | Olfactory function was assessed using the Visual Analogue Scale (VAS) before radiotherapy, at the end of radiotherapy, and at 3, 6, 12 month after radiotherapy. |
| Incidence of acquired nasal cavity stenosis and atresia | 1 year | Acquired nasal cavity stenosis and atresia was assessed by electronic nasopharyngoscopy before radiotherapy, at the end of radiotherapy, and at 3, 6, and 12 months after radiotherapy. |
Countries
China
Contacts
Primary ContactHai-Qiang Mai, Dr.
Backup ContactQiu-Yan Chen, Dr.
Outcome results
None listed