NCT05014191

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

4.5 years

First QC Date

August 14, 2021

Last Update Submit

September 6, 2025

Conditions

Radiation Toxicity

Outcome Measures

Primary Outcomes (1)

  • RTOG acute Skin toxicity (<3 months of starting RT)

    3 months after completion

Secondary Outcomes (1)

  • Total treatment time and the need for re-planning

    3 months for each patient

Study Arms (2)

Radiation therapy in frog leg position

Radiation therapy in straight leg position

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales only
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Hussein Cancer Center

Amman, Amman Governorate, 11941, Jordan

Location

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Fawzi J Abuhijla

    King Hussein Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2021

First Posted

August 20, 2021

Study Start

July 1, 2020

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

JO(1)