RecruitingPhase 3NCT05780372

Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma

Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: a Multi-center, Non-inferiority, Open-label, Randomized Controlled Phase III Clinical Trial

Sponsor

Sun Yat-sen University

Enrollment

474 participants

Start Date

Aug 8, 2023

Study Type

INTERVENTIONAL

Conditions

Radiotherapy; Complications Nasopharyngeal Carcinoma

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. The purpose of this study is to evaluate the efficacy of reduced neck prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare the radiotherapy-related adverse events and quality of life in two groups.

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 ≥ 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 Criteria11

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.

Interventions

RADIATIONIntensity Modulated Radiation Therapy

All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).

DRUGChemotherapy

Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition.