Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anal Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 into one of the two arms, which differ only in the diameter of a tampon used for vaginal dilatation du...
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 into one of the two arms, which differ only in the diameter of a tampon used for vaginal dilatation during treatment. All patients will receive standard (chemo)radiotherapy with a total dose of 45-50,4 Gy (single dose 1,8-2 Gy) to the pelvic and inguinal (if required) lymphatic drainage with a boost to the anal canal up to 54-60 Gy (single doses 1.8-2.2 Gy). The primary objective is the assessment of the incidence and grade of vaginal fibrosis 12 months after (chemo)radiotherapy for anal cancer depending on the extent of intrafractional vaginal dilatation. Secondary endpoints are clinical symptoms and toxicity according to the Common Toxicity Criteria (CTC) version 5.0, assessment of clinical feasibility of daily use of a tampon for vaginal dilatation, assessment of the compliance for the use of a vaginal dilatator and quality of life assessed with the EORTC-QLQ30/-ANL27 questionnaires.
Tracking Information
- NCT #
- NCT04094454
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nathalie Arians, MD University Hospital Heidelberg