Clinical Implementation of Surface-guided Radiation Therapy in Vulvar Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-18

Study Completion Date

2023-03-15

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Vulvar Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

optical surface monitoring system

Intervention Type DEVICE

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

Interventions

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optical surface monitoring system

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No