Back to resultsClinical Implementation of Surface-guided Radiation Therapy in Vulvar Cancer
Primary Purpose
Vulvar Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
optical surface monitoring system
Sponsored by
About this trial
This is an interventional treatment trial for Vulvar Cancer focused on measuring Vulvar cancer, Setup error, Intensity-modulated radiation therapy, Optical surface monitoring system
Eligibility Criteria
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.
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
optical surface monitoring system group
Arm Description
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.
Outcomes
Primary Outcome Measures
The absolute values of setup error
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.
The distribution of setup error
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05853549
First Posted
May 2, 2023
Last Updated
May 2, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05853549
Brief Title
Clinical Implementation of Surface-guided Radiation Therapy in Vulvar Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 18, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
March 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Cancer
Keywords
Vulvar cancer, Setup error, Intensity-modulated radiation therapy, Optical surface monitoring system
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
optical surface monitoring system group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
optical surface monitoring system
Intervention Description
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
Primary Outcome Measure Information:
Title
The absolute values of setup error
Description
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.
Time Frame
Through study completion, total an average of eight month
Title
The distribution of setup error
Description
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.
Time Frame
Through study completion, total an average of eight month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuquan Zhang, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
29933878
Citation
Hoisak JDP, Pawlicki T. The Role of Optical Surface Imaging Systems in Radiation Therapy. Semin Radiat Oncol. 2018 Jun;28(3):185-193. doi: 10.1016/j.semradonc.2018.02.003.
Results Reference
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Learn more about this trial
Clinical Implementation of Surface-guided Radiation Therapy in Vulvar Cancer
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