Stereotactic Radiotherapy for Sinonasal Malignancy

Active, not recruiting

• Conditions: Head and Neck Neoplasms
• Interventions: Radiation: SBRT by Cyberknife

• Registration Number: NCT06617910
• Lead Sponsor: Taichung Veterans General Hospital

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\'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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Primary Completion: 2024-08-31
• Status Verified: 2024-09
• Study First Submitted: 2024-09-22
• Study First Submitted QC: 2024-09-26
• Last Update Submitted: 2024-09-26
• Study First Posted: 2024-09-30
• Last Update Posted: 2024-09-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sinonasal malignancy patients received post-operative cyberknife	SBRT by Cyberknife	Sinonasal malignancy patients in our hospital receive curative surgery. These patients received post-operative radiotheray of SBRT by cyberknife.

Primary Outcome Measures

Name	Time	Method
Overall Survival, OS	Data within five years after treatment.	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.
Disease-Free Survival, DFS	Data within five years after treatment	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.
Local Control, LC	The observation periods are 1 year, 3 years, and 5 years after treatment.	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.
Distant Metastasis-Free Survival, DMFS	The observation periods are 1 year, 3 years,and 5 years after treatment.	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.

Secondary Outcome Measures

Name	Time	Method
treatment-related side effects	complications related to treatment within 30 days	Acute or chronic side effects caused by treatment can include radiation dermatitis, dry mouth, vision impairment, and so on.
Dosimetric Outcomes	Data for five years after treatment.	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.

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan