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

NCT06095154 | Recruiting Phase 3

• 1 other identifier: NPC009
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma by AJCC V8 Stage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• overall survival

  3 years

• Regional failure-free survival

  3 years

• Distant metastasis-free survival

  3 years

• Patient's quality-of-life

  3 years

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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

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

Experimental Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Disease progression during IMRT;
• Previous malignancy or other concomitant malignant diseases;
• The evaluation information of tumor efficacy can not be obtained;
• Receive blind treatment in other clinical research;
• Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);
• Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;
• Active systemic infection;
• No or limited capacity for civil conduct;
• 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;
• Pregnancy or lactation period;

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Cancer hospital

Fuzhou, Fujian, 351100, China

RECRUITING

Study Officials

• Shaojun Lin, DR

  Fujian Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Shaojun Lin, DR

CONTACT

13860603879; linshaojun@yeah.net

Qiaojuan Guo, DR

CONTACT

15080013157; guoqiaojuan163@.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2023
• First Posted: October 23, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

CN (1)