Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anal Cancer

Intervention / Treatment
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* Device: special tampon with a diameter of 28mm
* Device: standard tampon with a diameter of 12-13mm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tampon with extended vaginal dilatation<br>Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy | Device: special tampon with a diameter of 28mm<br>* patients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy<br>|
| Active Comparator: Commercially available tampon<br>Patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy | Device: standard tampon with a diameter of 12-13mm<br>* patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence and grade of vaginal fibrosis | during and after radiotherapy, clinical symptoms are assessed and graded | Up to 12 months after start of (chemo)radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical symptoms and toxicity according to the CTC AE version 5.0. criteria | during and after radiotherapy, clinical symptoms are assessed and graded according to the CTC AE v5.0 criteria | weekly during radiotherapy, at each follow-up visit | 
| clinical feasibility of daily use of a special tampon | daily assessment of the clinical feasibility of daily use of a special tampon | continously during radiotherapy | 
| assessment of the compliance for the use of a vaginal dilatator | patients will be instructed to use a vaginal dilator 3 times a week, at each follow-up visit patients are asked about the frequency of vaginal dilator use | continously at every follow-up visit | 
| assessment of quality of life | EORTC-QLQ30/-ANL27 questionnaires are used to assess quality of life | baseline, 6-8 weeks after and 6/12 months after finishing radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, female patients, vaginal dilator, vaginal fibrosis