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Active, Not Recruiting

NCT Number: NCT06617910

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taichung Veterans General Hospital

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

SBRT by Cyberknife

Radiation

The patients with sinonasal maliganacy receive curative surgery then receive adjuvant RT by the method of SBRT by Cyberknife.

Primary outcomes

  1. Overall Survival, OS

    Time frame: 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.

  2. Disease-Free Survival, DFS

    Time frame: 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.

  3. Local Control, LC

    Time frame: 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.

  4. Distant Metastasis-Free Survival, DMFS

    Time frame: 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 outcomes

  1. treatment-related side effects

    Time frame: 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.

  2. Dosimetric Outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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