Actively Recruiting
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy
Led by Juergen Debus · Updated on 2026-03-10
60
Participants Needed
1
Research Sites
391 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A commercially available vaginal dilator set will be used as measuring device. The grading of vaginal stenosis will be determined as difference of the diameter of vaginal dilator to the baseline. A reduction of the diameter of \<20% is defined as vaginal stenosis Grade 1, a reduction of 20-35% as Grade 2, a reduction of \>35-49% as Grade 3 and a reduction \>/=50% as Grade 4. The investigators hypothesize that the rate of vaginal stenosis Grade 1 or higher 12 months after radiotherapy is lower in the group using extended vaginal dilation during radiotherapy (Arm A). Rates of vaginal stenosis of 50% have been observed in previous patient collectives and the investigators hypothesize that a reduction to 25% is possible in the experimental group.
CONDITIONS
Official Title
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patient
- Histologically confirmed squamous anal cancer
- Indication for definitive or postoperative radiotherapy
- ECOG performance status 0 to 2
- Age over 18 years
- Written informed consent provided
You will not qualify if you...
- Patient refusal or inability to provide informed consent
- Unable to perform vaginal dilation before starting radiation treatment
- Prior pelvic irradiation with overlapping radiation fields
- Participation in another clinical trial that may affect this study's results
- Pregnancy, nursing, or inadequate contraception in women who can bear children
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany, 69120
Actively Recruiting
Research Team
N
Nathalie Arians, MD
CONTACT
M
Matthias Haefner, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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