Skip to main content
OpenTrials
Completed

NCT Number: NCT05014191

Treatment Positioning in Vulvar Cancer Radiation Therapy

The study investigators will conduct a prospective study on patients with non-metastatic vulvar cancer who will receive radiation treatment using Volumetric Arc Therapy (VMAT) modality with curative intent. Our aim is to compare straight-leg versus frog-leg position in terms of RTOG acute skin toxicity. Also, the study investigators will evaluate if positioning has an impact on the total treatment time and deviation on Cone Beam CT (CBCT) that might warrant re-simulation and consequently re-planning.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

King Hussein Cancer Center

Amman, Amman Governorate, 11941, Jordan

About this study

Vulvar cancer is a rare tumor with a prevalence of about 3-5% of gynecological malignancies with squamous cell carcinoma being the most common histopathologic subtype. It is more common among elderly and postmenopausal women.

Surgery is the cornerstone for the management of patients with early stage vulvar cancer. Radiotherapy is an integral part of the management of vulvar cancer both in the definitive and adjuvant settings.

Several studies have shown that intensity modulated radiotherapy IMRT is associated with better locoregional control compared with 3-dimensional conformal radiotherapy 3DCRT. In addition, it is associated with dosimetric advantage and better sparing of the organs at risk.

Historically, frog-leg position was the standard to provide better access for electron boost in conventional era. After evolution of inverse planning, electron boost is not further needed. Some centers have adopted straight-leg position.

There is paucity of literature regarding vulvar cancer in general and there is lack of data addressing radiation therapy treatment position specifically.

The study investigators will conduct a prospective study on patients with non-metastatic vulvar cancer who will receive radiation treatment using Volumetric Arc Therapy (VMAT) modality with curative intent. Our aim is to compare straight-leg versus frog-leg position in terms of RTOG acute skin toxicity. Also, the investigators will evaluate if positioning has an impact on the total treatment time and deviation on Cone Beam CT (CBCT) that might warrant re-simulation and consequently re-planning.

If both positions proved to be similar in terms of skin toxicity, then the investigators will adopt supine position in the treatment of all patients with vulvar cancer. It will be more comfortable position, and so more reproducible and this reproducibility will be reflected on better treatment outcomes.

Who can participate

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

Inclusion criteria

  • Age >= 18 years
  • ECOG PS = 0-1
  • Women with Bx confirmed vulvar cancer FIGO stage I-IVA (treated with curative intent)

Exclusion criteria

  • Patients whom radiotherapy plans do not cover inguinal lymph nodes will be excluded.

Vulnerable patients will be excluded (pregnant)

Treatment and study plan

Primary outcomes

  1. RTOG acute Skin toxicity (<3 months of starting RT)

    Time frame: 3 months after completion

Secondary outcomes

  1. Total treatment time and the need for re-planning

    Time frame: 3 months for each patient

Sponsors and collaborators

Lead sponsor

King Hussein Cancer Center

Other

Registry information

Official study title

Impact of Treatment Positioning on Radiation Therapy RTOG Toxicity in Patients With Vulvar Cancer

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2021
Registry last updated
Sep 12, 2025

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.

Published trials that share one or more normalized conditions with this study.