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

Phase 3

Not yet recruiting

• Conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage
• Interventions: Radiation: New-mode reduce-volume target IMRT

• Registration Number: NCT06095154
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

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.

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: GTVp + 5 mm; 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 Timeline

• Study First Submitted: 2023-10-14
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Study Start: 2025-01-01
• Primary Completion: 2027-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 474

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.

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New-mode reduced CTVp	New-mode reduce-volume target IMRT	Patients with newly diagnosed, non-metastatic NPC was given New-mode reduce-volume target IMRT. The CTVp was defined as a subclinical disease consisting of 10 mm margin surrounding GTVnx (not including all nasopharyngeal mucosa)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
overall survival	3 years	time from the date of the start of chemotherapy to death due to any cause
Regional failure-free survival	3 years	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.
Distant metastasis-free survival	3 years	The distant metastasis-free survival rate will be estimated using Kaplan-Meier
Patient's quality-of-life	3 years	uropean Organization for Research and Treatment of Cancer Quality-of-Life Head