CTV Delineation Based Solely on Geometric Expansion From GTV in Nasopharyngeal Carcinoma

CTV Delineation Based Solely on Geometric Expansion From GTV in Nasopharyngeal Carcinoma: A Prospective, Multi-center, Randomized Controlled Phase III Clinical Study

This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The aim of this study is to evaluate the efficacy and safety of modified IMRT, of which CTV delineation was only based on geometric expansion from GTV.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage
• Intervention / Treatment: Radiation: CTV Delineation Based on Geometric Expansion From GTV in Nasopharyngeal Carcinoma

Detailed Description

All enrolled patients underwent intensity-modulated radiation therapy (IMRT). The IMRT technique was selected based on the equipment available at each treatment center and the patients' preferences, including IMRT, VMAT, or TOMOTHERAPY. According to our study design, all enrolled patients will be randomly assigned in a 1:1 ratio before radiation therapy. The target area definitions are based on the international ICRU reports No. 50 and No. 60. The specific target area definitions and prescribed doses for the two groups are as follows:

1. GTVp (70Gy/33Fx) Experimental Group: Gross tumor as seen on imaging and nasopharyngoscopy; Control Group: Gross tumor as seen on imaging and nasopharyngoscopy.
2. CTVp1 (60Gy/33Fx) Experimental Group: None; Control Group: GTVp + 5 mm + entire nasopharyngeal mucosa.
3. CTVp2 (54Gy/33Fx) Experimental Group: GTVp + 10 mm + entire nasopharyngeal mucosa; Control Group: GTVp + 10 mm + high-risk anatomical structures.
4. GTVn Experimental Group: Lymph nodes as seen on imaging; Control Group: Lymph nodes as seen on imaging.
5. CTVn Experimental Group: Defined according to CACA/CMDA guidelines; Control Group: Defined according to CACA/CMDA guidelines.

• Study Type: Interventional
• Enrollment (Estimated): 474
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shaojun Lin, DR; Phone Number: 13860603879; Email: linshaojun@yeah.net
• Study Contact Backup: Name: Qiaojuan Guo, DR; Phone Number: 15080013157; Email: guoqiaojuan163@.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 351100
      • Recruiting
      • Fujian Cancer Hospital
      • Contact: Shaojun Lin, DR

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
2. No distant metastatic;
3. Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital;
4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
5. Signing informed consent;
6. Follow up regularly and comply with test requirements.

Exclusion Criteria:

1. Disease progression during IMRT;
2. Previous malignancy or other concomitant malignant diseases;
3. The evaluation information of tumor efficacy can not be obtained;
4. Receive blind treatment in other clinical research;
5. Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);
6. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;
7. Active systemic infection;
8. No or limited capacity for civil conduct;
9. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
10. Pregnancy or lactation period;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; GTVp (70Gy/33Fx): Gross tumor as seen on imaging and nasopharyngoscopy. CTVp1 (60Gy/33Fx): GTVp + 5 mm + entire nasopharyngeal mucosa. CTVp2 (54Gy/33Fx): GTVp + 10 mm + high-risk anatomical structures. GTVn: Lymph nodes as seen on imaging. CTVn: Defined according to CACA/CMDA guidelines.
Experimental: Experimental Group; GTVp (70Gy/33Fx): Gross tumor as seen on imaging and nasopharyngoscopy. CTVp1 (60Gy/33Fx): None. CTVp2 (54Gy/33Fx): GTVp + 10 mm + entire nasopharyngeal mucosa. GTVn: Lymph nodes as seen on imaging. CTVn: Defined according to CACA/CMDA guidelines.	Radiation: CTV Delineation Based on Geometric Expansion From GTV in Nasopharyngeal Carcinoma; CTVp2 is generated by expanding GTVp by 10 mm and including the nasopharyngeal mucosa.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local failure-free survival (LFFS)	The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	time from the date of the start of chemotherapy to death due to any cause	3 years
Regional failure-free survival	The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.	3 years
Distant metastasis-free survival	The distant metastasis-free survival rate will be estimated using Kaplan-Meier	3 years
Patient's quality-of-life	uropean Organization for Research and Treatment of Cancer Quality-of-Life Head	3 years

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital
• Investigators: Study Chair: Shaojun Lin, DR, Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: October 14, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Carcinoma
• Other Study ID Numbers: NPC009

Drug and device information, study documents

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