Status:
RECRUITING
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy
Lead Sponsor:
Juergen Debus
Conditions:
Anal Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 re...
Detailed Description
The study is designed as a prospective, randomized, two-armed, single-center phase-II-trial. 60 patients will be included in the study. Patients fulfilling the inclusion criteria will be randomized in...
Eligibility Criteria
Inclusion
- Female patient
- Histologically confirmed squamous anal cancer
- Indication for definitive or postoperative radiotherapy
- ECOG 0-2
- Age \> 18 years
- Written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04094454
Start Date
October 1 2019
End Date
October 1 2025
Last Update
January 5 2024
Active Locations (1)
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1
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany, 69120