Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

Anal Cancer Clinical Trial

— DILANA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094454
• Other study ID #: RADONK-DILANA-2018
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 2025

Study information

• Verified date: January 2024
• Source: University Hospital Heidelberg
• Contact: Nathalie Arians, MD
• Phone: +49 6221 568202
• Email: nathalie.arians[@]med.uni-heidleberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital of Heidelberg, Radiation Oncology	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Juergen Debus

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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