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Completed

NCT Number: NCT05853549

Clinical Implementation of Surface-guided Radiation Therapy in Vulvar Cancer

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

Completed

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Key information

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

optical surface monitoring system

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 10, 2023
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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