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

NCT ID: NCT06095154

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2030-12-31

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: 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.

Conditions

Nasopharyngeal Carcinoma by AJCC V8 Stage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CTV Delineation Based on Geometric Expansion From GTV in Nasopharyngeal Carcinoma

Intervention Type: RADIATION

CTVp2 is generated by expanding GTVp by 10 mm and including the nasopharyngeal mucosa.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shaojun Lin, DR

Role: STUDY_CHAIR

Fujian Cancer Hospital

Locations

Fujian Cancer hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shaojun Lin, DR

Role: CONTACT

linshaojun@yeah.net

13860603879

Qiaojuan Guo, DR

Role: CONTACT

guoqiaojuan163@.com

15080013157

Facility Contacts

Shaojun Lin, DR

Role: primary

Other Identifiers

NPC009

Identifier Type: -

Identifier Source: org_study_id