Clinical trial · Interventional
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| special tampon with a diameter of 28mm | Device | — | UNRESOLVED |
| standard tampon with a diameter of 12-13mm | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tampon with extended vaginal dilatation
- description
- Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy
- interventionNames
- Device: special tampon with a diameter of 28mm
- type
- ACTIVE_COMPARATOR
- label
- Commercially available tampon
- description
- Patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy
- interventionNames
- Device: standard tampon with a diameter of 12-13mm
Primary outcomes (1)
- measure
- incidence and grade of vaginal fibrosis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDArians N, Hafner M, Krisam J, Lang K, Wark A, Koerber SA, Hommertgen A, Debus J. Intrafractional vaginal dilation in anal cancer patients undergoing pelvic radiotherapy (DILANA) - a prospective, randomized, 2-armed phase-II-trial. BMC Cancer. 2020 Jan 21;20(1):52. doi: 10.1186/s12885-020-6547-7. PMID 31964381