NCT04094454 Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy
| NCT ID | NCT04094454 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Juergen Debus |
| Condition | Anal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2019-10-01 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2019-10-01 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Inclusion Criteria: * Female patient * Histologically confirmed squamous anal cancer * Indication for definitive or postoperative radiotherapy * ECOG 0-2 * Age \> 18 years * Written informed consent Exclusion Criteria: * 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
Contact & Investigator
Nathalie Arians, MD
PRINCIPAL INVESTIGATOR
University Hospital Heidelberg
Frequently Asked Questions
Who can join the NCT04094454 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Anal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04094454 currently recruiting?
Yes, NCT04094454 is actively recruiting participants. Contact the research team at nathalie.arians@med.uni-heidleberg.de for enrollment information.
Where is the NCT04094454 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT04094454 clinical trial?
NCT04094454 is sponsored by Juergen Debus. The principal investigator is Nathalie Arians, MD at University Hospital Heidelberg. The trial plans to enroll 60 participants.
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