Menu
Recruiting NCT06095154

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

Phase III Interventional Nasopharyngeal Carcinoma by AJCC V8 Stage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CTV Delineation Based on Geometric Expansion From GTV in Nasopharyngeal Carcinoma.
Who it may be relevant to
Registry conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Local failure-free survival (LFFS) [Time frame: 3 years]
Secondary outcome measures (4)
  • overall survival [Time frame: 3 years]
  • Regional failure-free survival [Time frame: 3 years]
  • Distant metastasis-free survival [Time frame: 3 years]
  • Patient's quality-of-life [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fujian Cancer hospital — Fuzhou

Identifiers

NCT: NCT06095154 · NPC009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗