- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05853549
Clinical Implementation of Surface-guided Radiation Therapy in Vulvar Cancer
May 2, 2023 updated by: Peking Union Medical College Hospital
A Prospective Study to Evaluated the Clinical Implementation Value of an Optical Surface Monitoring System in the Radiotherapy Setup for Patients With Vulvar Cancer, Compared to Standard Laser-based Setup
This prospective study evaluated the clinical implementation value of an optical surface monitoring system (OSMS) in the radiotherapy setup for patients with vulvar cancer, compared to standard laser-based setup
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This was a prospective single-centre trial to investigate the value of OSMS, and we hypothesized that using OSMS would reduce setup error in vulvar cancer treatment compared to a standard laser-based setup.
A dose of 45 Gy was delivered to the clinical target volume with intensity-modulated radiation therapy (IMRT) for a total of 25 fractions, followed by 16 to 24 Gy of local electron beam supplementation.
Marks were placed on each patient's skin to align the room lasers for presetup, and the setup was completed with information from the OSMS.
The deviation values in three translation directions, lateral (Lat), longitudinal (Lng), and vertical (Vrt), and three rotation directions, Rtn (rotation along the z-axis), Pitch (rotation along the x-axis), and Roll (rotation along the y-axis) were obtained.
The absolute values of setup error and error distribution of the standard laser-based setup and OSMS were compared.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Peking Union Medical College Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
- Age ≥18 years and ≤ 85 years.
- Patients with histologically confirmed vulvar cancer.
- No evidence of distant metastasis on CT, MRI or positron emission tomograph (PET)/CT.
- No contraindications to CT scanning.
- Indications for radiotherapy for vulvar cancer.
- Adequate marrow: neutrophile granulocyte count ≥1.5*10^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100*10^9/L.
- Normal liver and kidney function: Creatinine (Cr) < 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 2*upper limit of normal (ULN).
Exclusion Criteria:
- No pathological diagnosis.
- Remote metastasis.
- Anticipated intolerance of pelvic radiotherapy.
- Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: optical surface monitoring system group
Every radiotherapy fraction from each patients with OSMS technology.
Marks were placed on each patient's skin to align the room lasers for presetup, and the setup was completed with information from the OSMS.
The deviation values of setup were obtained.
The absolute values of setup error and error distribution of the standard laser-based setup and OSMS in the multi-directions were compared.
|
An optical surface monitoring system (OSMS) could achieve continuous monitoring of patient position through a nonradiographic and noninvasive technology, which has been widely applied to many sites of radiation therapy, including breast, intracranial, head and neck, abdomen, and extremities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The absolute values of setup error
Time Frame: Through study completion, total an average of eight month
|
Marks were placed on each patient's skin to align the room lasers for presetup, and the setup was completed with information from the OSMS.
The deviation values in multi-directions were obtained.
The absolute values of setup error of the standard laser-based setup and OSMS in the above six directions were compared.
|
Through study completion, total an average of eight month
|
The distribution of setup error
Time Frame: Through study completion, total an average of eight month
|
Marks were placed on each patient's skin to align the room lasers for presetup, and the setup was completed with information from the OSMS.
The deviation values in multi-directions were obtained.
The distribution of the standard laser-based setup and OSMS in the above six directions were compared.
|
Through study completion, total an average of eight month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Fuquan Zhang, M.D., Peking Union Medical College Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2022
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
March 15, 2023
Study Registration Dates
First Submitted
May 2, 2023
First Submitted That Met QC Criteria
May 2, 2023
First Posted (Actual)
May 10, 2023
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 2, 2023
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- pumch-OSMS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vulvar Cancer
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Gynecologic Oncology GroupNational Cancer Institute (NCI)Active, not recruitingStage III Vulvar Cancer | Vulvar Squamous Cell Carcinoma | Stage I Vulvar Cancer | Stage II Vulvar CancerUnited States, Canada
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedLymphedema | Perioperative/Postoperative Complications | Stage II Vulvar Cancer AJCC v7 | Stage IIIA Vulvar Cancer AJCC v7 | Stage IIIB Vulvar Cancer AJCC v7 | Stage IIIC Vulvar Cancer AJCC v7 | Stage IVA Vulvar Cancer AJCC v7 | Stage IA Vulvar Cancer AJCC v7 | Stage IB Vulvar Cancer AJCC v7 | Stage IVB...United States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)Active, not recruitingStage III Vulvar Cancer AJCC v7 | Stage IIIA Vulvar Cancer AJCC v7 | Stage IIIB Vulvar Cancer AJCC v7 | Stage IIIC Vulvar Cancer AJCC v7 | Vulvar Squamous Cell Carcinoma | Stage IVA Vulvar Cancer AJCC v7United States
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