Clinical trial NCT06617910: Stereotactic Radiotherapy for Sinonasal Malignancy
Official title: Treatment Outcomes and Dosimetric Analysis Comparison Between CyberKnife and VMAT Based Methods of Stereotactic Radiotherapy for Sinonasal Malignancy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Head and Neck Neoplasms
Keywords: Sinonasal Malignancy
SBRT
CyberKnife
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief summary: 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\&#39;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\&#39;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).


Eligibility criteria: 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 \&amp;gt;=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.

Primary outcomes:
measure: Overall Survival, OS
timeFrame: Data within five years after treatment.
measure: Disease-Free Survival, DFS
timeFrame: Data within five years after treatment
measure: Local Control, LC
timeFrame: The observation periods are 1 year, 3 years, and 5 years after treatment.
measure: Distant Metastasis-Free Survival, DMFS
timeFrame: The observation periods are 1 year, 3 years,and 5 years after treatment.
Secondary outcomes:
measure: treatment-related side effects
timeFrame: complications related to treatment within 30 days
measure: Dosimetric Outcomes
timeFrame: Data for five years after treatment.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References: