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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Female patient

• Histologically confirmed squamous anal cancer

• Indication for definitive or postoperative radiotherapy

• ECOG 0-2

• Age \> 18 years

• Written informed consent

Locations
Other Locations
Germany
University Hospital of Heidelberg, Radiation Oncology
RECRUITING
Heidelberg
Contact Information
Primary
Nathalie Arians, MD
nathalie.arians@med.uni-heidleberg.de
+49 6221 568202
Backup
Matthias Haefner, MD
matthias.heafner@med.uni-heidelberg.de
+49 6221 568202
Time Frame
Start Date: 2019-10-01
Estimated Completion Date: 2025-10
Participants
Target number of participants: 60
Treatments
Experimental: Tampon with extended vaginal dilatation
Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy
Active_comparator: Commercially available tampon
Patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy
Related Therapeutic Areas
Sponsors
Leads: Juergen Debus

This content was sourced from clinicaltrials.gov

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