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NCT Number: NCT04094454

Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

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.

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Key information

Conditions

Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

special tampon with a diameter of 28mm

Device

patients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy

standard tampon with a diameter of 12-13mm

Device

patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy

Primary outcomes

  1. incidence and grade of vaginal fibrosis

    Time frame: Up to 12 months after start of (chemo)radiotherapy

    during and after radiotherapy, clinical symptoms are assessed and graded

Secondary outcomes

  1. clinical symptoms and toxicity according to the CTC AE version 5.0. criteria

    Time frame: weekly during radiotherapy, at each follow-up visit

    during and after radiotherapy, clinical symptoms are assessed and graded according to the CTC AE v5.0 criteria

  2. clinical feasibility of daily use of a special tampon

    Time frame: continously during radiotherapy

    daily assessment of the clinical feasibility of daily use of a special tampon

  3. assessment of the compliance for the use of a vaginal dilatator

    Time frame: continously at every follow-up visit

    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

  4. assessment of quality of life

    Time frame: baseline, 6-8 weeks after and 6/12 months after finishing radiotherapy

    EORTC-QLQ30/-ANL27 questionnaires are used to assess quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Matthias Haefner, MD

CONTACT

[email protected]

+49 6221 568202

Nathalie Arians, MD

CONTACT

[email protected]

+49 6221 568202

Sponsors and collaborators

Lead sponsor

Juergen Debus

Other

Registry information

Official study title

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

Acronym: DILANA

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2019
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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