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NCT05014191 Clinical Trial

Treatment Positioning in Vulvar Cancer Radiation Therapy

Radiation Toxicity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05014191
Other study ID # 20 KHCC 1111
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 1, 2024

Study information
Verified date March 2024
Source King Hussein Cancer Center
Contact FAWZI J Abuhijla, MD, MSc
Phone +962796500577
Email fhijle@khcc.jo
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Jordan King Hussein Cancer Center Amman

Sponsors (1)
Lead Sponsor Collaborator
King Hussein Cancer Center

Country where clinical trial is conducted

Jordan, 

Outcome
Type Measure Description Time frame Safety issue
Primary RTOG acute Skin toxicity (<3 months of starting RT) 3 months after completion
Secondary Total treatment time and the need for re-planning 3 months for each patient
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