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

NCT ID: NCT06244394

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-12-10

Brief 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.

Conditions

Nasopharyngeal Carcinoma; Radiation-Induced Temporal Lobe Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

NPC patients with RTLI after IMRT

nasopharyngeal carcinoma patients with radiation-induced temporal lobe injury after intensity-modulated radiation therapy

intensity-modulated radiotherapy

Intervention Type: 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.

NPC patients without RTLI after IMRT

nasopharyngeal carcinoma patients without radiation-induced temporal lobe injury after intensity-modulated radiation therapy

intensity-modulated radiotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lirong Wu

Associate chiefphysician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

RTLI prediction model

Identifier Type: -

Identifier Source: org_study_id