About this trial
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.
Eligibility criteria
Qualifiers
Female patient
Histologically confirmed squamous anal cancer
Indication for definitive or postoperative radiotherapy
ECOG 0-2
Disqualifiers
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
Trial design
Treatments tested in this trial
- special tampon with a diameter of 28mm
- standard tampon with a diameter of 12-13mm
Treatment groups
Locations
1Sponsors and collaborators
Juergen Debus
Lead sponsor
University Hospital Heidelberg
Sponsor institution