Treatment Positioning in Vulvar Cancer Radiation Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Radiation Toxicity

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Jordan
  • Amman Governorate
    • Amman, Amman Governorate, Jordan, 11941
      • King Hussein Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Women who were diagnosed with vulvar carcinoma, receiving adjuvant or definitive chemoradiation to primary disease and inguinal lymph nodes

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Radiation therapy in frog leg position
Radiation therapy in straight leg position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
RTOG acute Skin toxicity (<3 months of starting RT)	3 months after completion

Secondary Outcome Measures

Outcome Measure	Time Frame
Total treatment time and the need for re-planning	3 months for each patient

Collaborators and Investigators

• Sponsor: King Hussein Cancer Center
• Investigators: Principal Investigator: Fawzi J Abuhijla, King Hussein Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: August 14, 2021
• First Submitted That Met QC Criteria: August 14, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 6, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Radiation Injuries
• Other Study ID Numbers: 20 KHCC 1111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No