Clinical trial NCT05853549: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vulvar Cancer
Keywords: Vulvar cancer
Setup error
Intensity-modulated radiation therapy
Optical surface monitoring system
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
2. Age ≥18 years and ≤ 85 years.
3. Patients with histologically confirmed vulvar cancer.
4. No evidence of distant metastasis on CT, MRI or positron emission tomograph (PET)/CT.
5. No contraindications to CT scanning.
6. Indications for radiotherapy for vulvar cancer.
7. Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L.
8. 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:

1. No pathological diagnosis.
2. Remote metastasis.
3. Anticipated intolerance of pelvic radiotherapy.
4. 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.

Primary outcomes:
measure: The absolute values of setup error
timeFrame: Through study completion, total an average of eight month
measure: The distribution of setup error
timeFrame: Through study completion, total an average of eight month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Fuquan Zhang, M.D.
role: STUDY_CHAIR
References:
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.