Treatment Positioning in Vulvar Cancer Radiation Therapy

Last updated: March 17, 2024
Sponsor: King Hussein Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05014191
20 KHCC 1111
  • Ages 18-80
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Patients whom radiotherapy plans do not cover inguinal lymph nodes will be excluded. Vulnerable patients will be excluded (pregnant)

Study Design

Total Participants: 20
Study Start date:
July 01, 2020
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • King Hussein Cancer Center

    Amman, 11941
    Jordan

    Active - Recruiting

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