Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy
Recruiting · NCT04094454 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Female patient
- Histologically confirmed squamous anal cancer
- Indication for definitive or postoperative radiotherapy
- ECOG 0-2
- Age \> 18 years
- Written informed consent
Exclusion criteria
- 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
1 location listed.
- University Hospital of Heidelberg, Radiation Oncology - Heidelberg, Germany