Head and Neck NeoplasmsNCT06617910
Stereotactic Radiotherapy for Sinonasal Malignancy
An observational study of Head and Neck Neoplasms, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- SBRT by Cyberknife
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2023to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Head and Neck Neoplasms
- Being tested
- SBRT by Cyberknife
- Keywords
- Sinonasal Malignancy, SBRT, CyberKnife
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT by CyberknifeRadiation
The patients with sinonasal maliganacy receive curative surgery then receive adjuvant RT by the method of SBRT by Cyberknife.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: SBRT by Cyberknife |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The observation periods are 1 year, 3 years,and 5 years after treatment.
Secondary outcomes (2)
treatment-related side effects
Acute or chronic side effects caused by treatment can include radiation dermatitis, dry mouth, vision impairment, and so on.
Measured: 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.
Measured: Data for five years after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Sep 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617910
- Sponsor's protocol ID
- CE23395C
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcomes and Dosimetric Analysis Comparison Between CyberKnife and VMAT Based Methods of Stereotactic Radiotherapy for Sinonasal Malignancy
- ClinicalTrials.gov ID
- NCT06617910
- Acronym / sponsor ID
- CE23395C
- Conditions
- Head and Neck Neoplasms
- Keywords
- Sinonasal Malignancy, SBRT, CyberKnife
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinonasal malignancy patients received post-operative cyberknife | – | Radiation: SBRT by CyberknifeSinonasal malignancy patients in our hospital receive curative surgery. These patients received post-operative radiotheray of SBRT by cyberknife. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT by CyberknifeThe patients with sinonasal maliganacy receive curative surgery then receive adjuvant RT by the method of SBRT by Cyberknife. | Radiation | Sinonasal malignancy patients received post-operative cyberknife |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
treatment-related side effects
Time frame: complications related to treatment within 30 days
Dosimetric Outcomes
Time frame: Data for five years after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival, OS (time frame: Data within five years after treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.