Retrospective Study on the Prediction of Radiation-induced Brain Injury in Patients With Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Retrospective Study to Establish a Prediction Model for Radiation-induced Brain Damage in Nasopharyngeal Carcinoma Patients Based on Pretreatment Imaging and Radiotherapy Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06244394
• Other study ID #: RTLI prediction model
• Status: Completed
• Start date: June 1, 2023
• Est. completion date: December 10, 2023

Study information

• Verified date: January 2024
• Source: Jiangsu Cancer Institute & Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Radiation therapy has become the preferred treatment for nasopharyngeal cancer due to the sensitivity of nasopharyngeal carcinoma to radiation. However, even with the use of intensity-modulated radiation therapy (IMRT), radiation-induced temporal lobe injury (RTLI) can be a severe complication. Patients with RTLI may experience long-term memory loss, personality changes, physical dysfunctions, and other symptoms, which seriously impair their quality of life and long-term prognosis. Currently, the diagnosis of RTLI primarily relies on clinical symptoms and imaging examinations such as computed tomography (CT) and conventional MRI. However, these methods only enable the diagnosis of RTLI at a late stage when it is irreversible and cannot be effectively treated. Therefore, the early identification or individualized prediction of RTLI after IMRT holds exceptional importance for improving the quality of life in nasopharyngeal carcinoma patients. The exact mechanism of RTLI remains unclear. Many clinical covariates have been proven to be associated with RTLI in NPC patients, including stage, age, and dosimetric parameters. In addition, it was reported that each patient's temporal lobe exhibits unique genetic susceptibility to radiation exposure. In this study, we aim to predict the occurrence of RTLI by analyzing clinical factors and heterogeneity of temporal lobe tissue prior to irradiation. Finally, we want to construct and validate a prediction model for RLTI, which can support clinician decision-making in developing individualized treatment plans and providing preventive measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• (1) pathological confirmation of NPC; (2) receipt of IMRT; (3) nasopharynx-neck MRI within 2 weeks before antineoplastic treatment

Exclusion Criteria:

• (1) temporal lobe invasion; (2) with central nervous system diseases except RTLI; (3) receiving additional radiation after IMRT; (4) incomplete clinical or imaging data

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Radiation:
• intensity-modulated radiotherapy
All patients were staged according to the 8th edition of the TNM classification by the American Joint Committee on Cancer/Union for International Cancer Control and received a standardized treatment regimen including IMRT and concurrent or adjuvant chemotherapy. Inverse IMRT treatment planning was performed on a Varian Inspiration Platform (version 10.0), using the simultaneous integrated boost technique. The prescribed doses were 68-75 Gy to the PTV of the GTVnx in 32-34 fractions; 64-75 Gy to the PTV of the GTVnd in 32-34 fractions; 60 Gy to the PTV of CTV1 in 32 fractions; and 50 Gy to the PTV of CTV2 in 28 fractions. All patients were given one fraction daily 5 days a week. The dose-volume-histograms (DVHs) of the organs at risk were evaluated as described in the radiation therapy oncology group (RTOG) 0225 protocol to prevent violation of the tolerance limits.

Locations

Country	Name	City	State
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Cancer Institute & Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NPC patients with RTLI	Patients with nasopharyngeal cancer who were diagnosed with radiation-induced brain injury during follow-up period	three years
Primary	NPC patients without RTLI	Patients with nasopharyngeal cancer who were not diagnosed with radiation-induced	three years