Clinical trial NCT06095154: CTV Delineation Based Solely on Geometric Expansion From GTV in Nasopharyngeal Carcinoma
Official title: CTV Delineation Based Solely on Geometric Expansion From GTV in Nasopharyngeal Carcinoma: A Prospective, Multi-center, Randomized Controlled Phase III Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-23
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Local failure-free survival (LFFS)
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
measure: Regional failure-free survival
timeFrame: 3 years
measure: Distant metastasis-free survival
timeFrame: 3 years
measure: Patient's quality-of-life
timeFrame: 3 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer hospital
state: Fujian
Study officials:
affiliation: Fujian Cancer Hospital
name: Shaojun Lin, DR
role: STUDY_CHAIR
References: