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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimized CTV | Experimental | The contralateral CTV1 was defined as a subclinical disease consisting of 5mm margin surrounding GTVnx.The CTV2 was defined as potentially involved regions consisting of 5mm margin surrounding CTV1, and contralateral CTV2 only included the pharyngeal recess. |
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| Conventional CTV | No Intervention | The CTV1 was defined as GTVnx + 5 mm + entire nasopharynx mucosa .The CTV2 was defined as GTV1+ 5 mm + corresponding anatomical structures. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTV optimized IMRT | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute adverse reactions | The acute adverse reactions of patients during or after radiotherapy were evaluated with the corresponding standard scales. | 3 months |
| Control rate of non-irradiated area | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence-free survival(LRFS) | The duration of time to LRFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause. | 36 months |
| Progress-free survival(PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuwei Wang, M.M. | Contact | 13436161758 | 38664816@qq.com | |
| Ying Wang, Ph.D,M.D. | Contact | 13996412826 | yingwang197011@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Wang, Ph.D, M.D. | Chongqing University Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing University Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | 400030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40831921 | Derived | Song Y, Wang Y, Yang M, Yu X, Li M, Long B, Shu X, Zhang X, Wang F, Wang C, Hu M, Sui JD, Wang Y. Individualization of clinical target volume delineation in eccentric nasopharyngeal carcinoma: a prospective comparative study. Front Oncol. 2025 Aug 4;15:1587764. doi: 10.3389/fonc.2025.1587764. eCollection 2025. |
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Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
| 36 months |
| Overall survival (OS) | Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive. | 36 months |