Nasopharyngeal Carcinoma by AJCC V8 Stage
Conditions
Brief summary
This is a prospective, single-center clinical trial in eccentric nasopharyngeal carcinoma (NPC) patients. The aim of this study is to evaluate the efficacy and safety of NBI combined with MRI-guided optimized CTV compared with conventional CTV, and to compare the radiotherapy-related adverse events and quality of life between the two groups.
Detailed description
All patients with eccentric nasopharyngeal carcinoma were selected on the basis of MRI findings and NBI endoscopy was performed in these patients. The patients were enrolled if both NBI endoscopy and MRI showed eccentric NPC. Patients with contralateral tissue mucosal abnormalities detected by NBI and confirmed by biopsy were excluded. Then the patients were randomly divided into an experimental group (Optimized CTV) or a control group (Conventional CTV) to evaluate the efficacy and safety of the two groups, as well as radiotherapy-related adverse events.
Interventions
RADIATIONCTV optimized IMRT
The contralateral CTV1 was defined as a subclinical disease consisting of 5mm margin surrounding GTVnx.The CTV2 was defined as a potentially involved regions consisting of 5mm margin surrounding CTV1, and contralateral CTV2 only included the pharyngeal recess.
Sponsors
Chongqing University Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females ≥18 years of age; 2. ECOG Performance Status 0,1 or 2; 3. Pathologically diagnosed as nasopharyngeal carcinoma; 4. Pretreatment nasopharynx and neck MRI imaging; 5. Nasopharyngeal suspected lesions were examined by NBI endoscopy; 6. Meeting the definition of eccentric NPC with ipsilateral (affected side) staging of T1-4 and contralateral (healthy side) staging of T0; 7. Patients evaluated without contraindications to radiotherapy; 8. Voluntary participation in clinical research, and signed informed consent.
Exclusion criteria
1. Patients who did not successfully undergo all three examinations (MRI, NBI, and endoscopic biopsy); 2. Other rare pathological types, such as adenocarcinoma; 3. Patients with tumor invasion of the clivus; 4. Patients whose contralateral retropharyngeal lymph nodes met the diagnostic criteria; 5. Invasion of paranasal sinuses (except simple sphenoid invasion).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute adverse reactions | 3 months | The acute adverse reactions of patients during or after radiotherapy were evaluated with the corresponding standard scales. |
| Control rate of non-irradiated area | 36 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence-free survival(LRFS) | 36 months | The duration of time to LRFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause. |
| Progress-free survival(PFS) | 36 months | Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first. |
| Overall survival (OS) | 36 months | Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive. |
Countries
China
Contacts
Primary ContactYuwei Wang, M.M.
Backup ContactYing Wang, Ph.D,M.D.
Outcome results
None listed