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

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

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy
• Intervention / Treatment: Radiation: Optimised neck CTV; Radiation: standard neck CTV

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.

• Study Type: Interventional
• Enrollment (Estimated): 524
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gui-qiong Xu, MD; Phone Number: +8613528109888; Email: donna_shee@163.com

Study Locations

• China
  • Guangdong
    • Zhongshan, Guangdong, China, 528403
      • Recruiting
      • Zhongshan City People's Hospital
      • Contact: Gui-qiong Xu, MD; Phone Number: +8613528109888; Email: donna_shee@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; optimised neck CTV delineation	Radiation: Optimised neck CTV; neck CTV delineation extends from the lateral process of C1
Active Comparator: Control Group; standard neck CTV delineation	Radiation: standard neck CTV; neck CTV delineation extends from skull base

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional recurrence free survival	From the date of randomization to regional recurrence or any death	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up	3 years
Distant metastasis-free survival	From the date of randomization to distant metastasis or any death	3 years
Progression free survival	From the date of randomization to local or regional recurrence, distant metastasis or any death	3 years
Acute toxicities	Assessed with CTCAE v5.0	From the start of treatment until 3 months post treatment
Local recurrence free survival	From the date of randomization to local recurrence or any death	3 years
Late toxicities	Assessed with Radiation Therapy Oncology Group criteria and the CTCAE v5.0	3 years post treatment

Collaborators and Investigators

• Sponsor: Zhongshan People's Hospital, Guangdong, China
• Investigators: Principal Investigator: Gui-qiong Xu, MD, Zhongshan People's Hospital, Guangdong, China

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2029

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Nasopharyngeal Neoplasms; Salivary Gland Diseases; Carcinoma; Nasopharyngeal Carcinoma; Xerostomia
• Other Study ID Numbers: ZSCPH-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No