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Trial Title:
CTV Delineation Based Solely on Geometric Expansion From GTV in Nasopharyngeal Carcinoma
NCT ID:
NCT06095154
Condition:
Nasopharyngeal Carcinoma by AJCC V8 Stage
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
CTV Delineation Based on Geometric Expansion From GTV in Nasopharyngeal Carcinoma
Description:
CTVp2 is generated by expanding GTVp by 10 mm and including the nasopharyngeal mucosa.
Arm group label:
Experimental Group
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.
Criteria for 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;
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 1, 2025
Completion date:
December 31, 2030
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06095154
