Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

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Brief Title

Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

Official Title

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

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.
    

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.
    


Study Type

Interventional


Primary Outcome

incidence and grade of vaginal fibrosis

Secondary Outcome

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

Condition

Anal Cancer

Intervention

special tampon with a diameter of 28mm

Study Arms / Comparison Groups

 Tampon with extended vaginal dilatation
Description:  Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

60

Start Date

October 1, 2019

Completion Date

October 2024

Primary Completion Date

October 2023

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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Nathalie Arians, MD, +49 6221 568202, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT04094454

Organization ID

RADONK-DILANA-2018


Responsible Party

Sponsor-Investigator

Study Sponsor

Juergen Debus


Study Sponsor

Nathalie Arians, MD, Principal Investigator, University Hospital Heidelberg


Verification Date

June 2021