Nasopharyngeal Carcinoma by AJCC V8 Stage
Conditions
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.
Interventions
RADIATIONCTV Delineation Based on Geometric Expansion From GTV in Nasopharyngeal Carcinoma
CTVp2 is generated by expanding GTVp by 10 mm and including the nasopharyngeal mucosa.
Sponsors
Fujian Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local failure-free survival (LFFS) | 3 years | The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 3 years | time from the date of the start of chemotherapy to death due to any cause |
| Regional failure-free survival | 3 years | The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test. |
| Distant metastasis-free survival | 3 years | The distant metastasis-free survival rate will be estimated using Kaplan-Meier |
| Patient's quality-of-life | 3 years | uropean Organization for Research and Treatment of Cancer Quality-of-Life Head |
Countries
China
Contacts
Primary ContactShaojun Lin, DR
Backup ContactQiaojuan Guo, DR
Outcome results
None listed