An observational study in Radiation Toxicity, sponsored by King Hussein Cancer Center. Completed at 1 site in Jordan. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by King Hussein Cancer Center · Observational
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.
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.
108 studies on the registry are indexed under Radiation Injuries; 46 are open to participants now.
This study's enrollment of 20 is below the median of 105 across 41 observational studies indexed under Radiation Injuries.
Browse Radiation Injuries studies →King Hussein Cancer Center is the lead sponsor of 23 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women who were diagnosed with vulvar carcinoma, receiving adjuvant or definitive chemoradiation to primary disease and inguinal lymph nodes
Exclusion Criteria:
Vulnerable patients will be excluded (pregnant)
RTOG acute Skin toxicity (<3 months of starting RT)
Time frame: 3 months after completion
Total treatment time and the need for re-planning
Time frame: 3 months for each patient
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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King Hussein Cancer Center