King Hussein Cancer Center
Amman, Amman Governorate, 11941, Jordan
NCT Number: NCT05014191
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.
Looking for future studies?
Notify Me18 year–80 year
Female
Observational
Amman, Amman Governorate, 11941, Jordan
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vulnerable patients will be excluded (pregnant)
Time frame: 3 months after completion
Time frame: 3 months for each patient
King Hussein Cancer Center
Other
Impact of Treatment Positioning on Radiation Therapy RTOG Toxicity in Patients With Vulvar Cancer
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.
NCT04670016
Brain Diseases, Brain Neoplasms
Calgary, Alberta, Canada
View Trial DetailsNCT02259218
Adult Brain Tumor, Brain Diseases
Columbus, Ohio, United States
View Trial DetailsNCT02589938
Head and Neck Cancer, Head and Neck Neoplasms
Burbank, California, United States
View Trial DetailsNCT04528225
Breast Diseases, Breast Neoplasms
Beijing, Beijing Municipality, China
View Trial Details