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NCT Number: NCT06244394

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensity-Modulated Radiotherapy

Radiation

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.

Primary outcomes

  1. NPC patients with RTLI

    Time frame: three years

    Patients with nasopharyngeal cancer who were diagnosed with radiation-induced brain injury during follow-up period

  2. NPC patients without RTLI

    Time frame: three years

    Patients with nasopharyngeal cancer who were not diagnosed with radiation-induced

Sponsors and collaborators

Lead sponsor

Jiangsu Cancer Institute & Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2024
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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