Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy
Recruiting now · Not applicable
Conditions studied: Anal Cancer
In brief
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.
Key facts
- Study ID
- NCT04094454
- Run by
- Juergen Debus
- People needed
- 60
- Starts
- 2019-10-01
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-03-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female patient
- Histologically confirmed squamous anal cancer
- Indication for definitive or postoperative radiotherapy
- ECOG 0-2
- Age > 18 years
- Written informed consent
You may not qualify if…
- patients refusal or incapability of informed consent
- no vaginal dilatation possible prior to radiation treatment start
- prior pelvic irradiation (if direct field border or even overlap of radiation fields assumed)
- participation in another clinical trial which might influence the results of the DILANA trial
- pregnancy/nursing period or inadequate contraception in women with child bearing potential
Where it is running
- University Hospital of Heidelberg, Radiation Oncology — Heidelberg, Germany (enrolling)
Full record on ClinicalTrials.gov
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