Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

Overview

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.

Full Title of Study: “Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy – Prospective, Randomized, Two-armed Phase-II-study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2023

Detailed 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 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.

Interventions

  • Device: special tampon with a diameter of 28mm
    • patients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy
  • Device: standard tampon with a diameter of 12-13mm
    • patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy

Arms, Groups and Cohorts

  • Experimental: Tampon with extended vaginal dilatation
    • Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy
  • Active Comparator: Commercially available tampon
    • Patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Juergen Debus
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Juergen Debus, Principal Ivestigator – University Hospital Heidelberg
  • Overall Official(s)
    • Nathalie Arians, MD, Principal Investigator, University Hospital Heidelberg
  • Overall Contact(s)
    • Nathalie Arians, MD, +49 6221 568202, nathalie.arians@med.uni-heidleberg.de

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