Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

ConditionAnal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJuergen Debus

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

60 Participants
are divided into 2 treatment groups

Locations

1
University Hospital of Heidelberg, Radiation Oncology69120, Heidelberg Germany

Sponsors and collaborators

Juergen Debus

Lead sponsor

University Hospital Heidelberg

Sponsor institution