Stereotactic Radiotherapy for Sinonasal Malignancy

Treatment Outcomes and Dosimetric Analysis Comparison Between CyberKnife and VMAT Based Methods of Stereotactic Radiotherapy for Sinonasal Malignancy

Sinonasal Tumors are a rare type of head and neck tumor, accounting for approximately 3% of head and neck cancers. Treatment primarily involves surgical intervention, with radiation therapy as an adjunct. Due to the tumor's anatomical location near critical structures such as the eyes, optic nerves, optic chiasm, brainstem, and oral cavity, if the tumor cannot be completely resected, postoperative radiation therapy is often necessary. Given the complexity of the tumor's anatomical position, subsequent radiation therapy planning becomes more challenging, as it must balance tumor control and organ preservation. This study retrospectively analyzes patients with sinonasal tumors who received stereotactic radiosurgery (CyberKnife) at our hospital, comparing the dosimetric advantages, treatment efficacy, survival analysis, and side effects with those of volumetric modulated arc therapy (VMAT).

Study Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Radiation: SBRT by Cyberknife

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The sixth-generation computer-assisted radiotherapy system was introduced at this hospital in 2019. This study will attempt to analyze the dose differences between treatment plans using traditional linear accelerators and those using the computer-assisted system for patients who received stereotactic radiotherapy at this hospital over the past five years.

Description

Inclusion Criteria:

• The pathological tissue report from the endoscopic surgery at this hospital confirmed a diagnosis of malignant sinus tumor.
• Received radical stereotactic radiotherapy at this hospital.
• Pre-treatment baseline imaging (CT or MRI) was performed.
• Received radical radiotherapy at this hospital and has been under long-term follow-up with complete medical records at this hospital.

Exclusion Criteria:

• Local lymphatic metastasis and distant metastasis have been excluded by imaging examinations (cN >=1, M =1).
• Not treated with radical radiotherapy at this hospital and has been under long-term follow-up at this hospital with incomplete medical records.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sinonasal malignancy patients received post-operative cyberknife; Sinonasal malignancy patients in our hospital receive curative surgery. These patients received post-operative radiotheray of SBRT by cyberknife.	Radiation: SBRT by Cyberknife; The patients with sinonasal maliganacy receive curative surgery then receive adjuvant RT by the method of SBRT by Cyberknife.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival, OS	Determine the start dates of surgery and radiotherapy from the hospital's medical record system, and collect data on death events, regardless of whether they are tumor-related.	Data within five years after treatment.
Disease-Free Survival, DFS	Determine the treatment start date from the hospital's medical record system, and confirm whether there is any disease recurrence or progression through follow-up data or imaging examination results.	Data within five years after treatment
Local Control, LC	Measure the proportion of no recurrence in the local tumor area after treatment. Researchers determine the treatment start date from the hospital's medical record system and confirm the presence or absence of local tumor recurrence through follow-up data, imaging examinations, and pathology results.	The observation periods are 1 year, 3 years, and 5 years after treatment.
Distant Metastasis-Free Survival, DMFS	Measure the time until the occurrence of distant metastasis after treatment. Researchers first determine the treatment start date, and then assess distant metastasis through data, imaging examinations, and clinical evaluations.	The observation periods are 1 year, 3 years,and 5 years after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment-related side effects	Acute or chronic side effects caused by treatment can include radiation dermatitis, dry mouth, vision impairment, and so on.	complications related to treatment within 30 days
Dosimetric Outcomes	The quality of a radiation therapy plan can be assessed through dose uniformity and dose constraints for adjacent critical organs (such as the optic nerve and brainstem). Researchers first collect dose distribution data from the treatment planning system and use dose calculation software to analyze dose uniformity indices (such as the homogeneity index) to evaluate the distribution of doses. At the same time, dose constraint standards for adjacent critical organs are established to ensure that the doses to these organs remain within safe limits during treatment. These indicators reflect the quality of the radiation therapy plan and can help researchers assess the safety and efficacy of the treatment.	Data for five years after treatment.

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): August 31, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: September 22, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: SBRT; CyberKnife; Sinonasal Malignancy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: CE23395C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No