RecruitingNot ApplicableNCT04094454

Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study

Sponsor

Juergen Debus

Enrollment

60 participants

Start Date

Oct 1, 2019

Study Type

INTERVENTIONAL

Conditions

Anal Cancer

Summary

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

Female patient
Histologically confirmed squamous anal cancer
Indication for definitive or postoperative radiotherapy
ECOG 0-2
Age \> 18 years
Written informed consent

Exclusion Criteria5

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