Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy (DILANA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anal Cancer
• Intervention / Treatment: Device: special tampon with a diameter of 28mm; Device: standard tampon with a diameter of 12-13mm

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
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalie Arians, MD; Phone Number: +49 6221 568202; Email: nathalie.arians@med.uni-heidleberg.de
• Study Contact Backup: Name: Matthias Haefner, MD; Phone Number: +49 6221 568202; Email: matthias.heafner@med.uni-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • University Hospital of Heidelberg, Radiation Oncology
    • Contact: Jürgen Debus, Prof. Dr.; Phone Number: 8202 +49-6221-56; Email: juergen.debus@med.uni-heidelberg.de
    • Contact: Adriane Hommertgen; Phone Number: 8202 +49-6221-56; Email: adriane.hommertgen@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Juergen Debus
• Investigators: Principal Investigator: Nathalie Arians, MD, University Hospital Heidelberg

Publications and helpful links

General Publications

• Arians 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; female patients; vaginal dilator; vaginal fibrosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Anus Diseases; Anus Neoplasms
• Other Study ID Numbers: RADONK-DILANA-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No