Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

NCT ID: NCT04094454

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2025-10-31

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.

Conditions

Anal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Tampon with extended vaginal dilatation

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

Group Type: EXPERIMENTAL

special tampon with a diameter of 28mm

Intervention Type: DEVICE

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

Commercially available tampon

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

Group Type: ACTIVE_COMPARATOR

standard tampon with a diameter of 12-13mm

Intervention Type: DEVICE

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

Interventions

special tampon with a diameter of 28mm

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

Intervention Type: 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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Juergen Debus

OTHER

Sponsor Role: lead

Responsible Party

Juergen Debus

Principal Ivestigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nathalie Arians, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Nathalie Arians, MD

Role: CONTACT

nathalie.arians@med.uni-heidleberg.de

+49 6221 568202

Matthias Haefner, MD

Role: CONTACT

matthias.heafner@med.uni-heidelberg.de

+49 6221 568202

Facility Contacts

Jürgen Debus, Prof. Dr.

Role: primary

juergen.debus@med.uni-heidelberg.de

+49-6221-56 ext. 8202

Adriane Hommertgen

Role: backup

adriane.hommertgen@med.uni-heidelberg.de

+49-6221-56 ext. 8202

References

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.

Reference Type: DERIVED

PMID: 31964381 (View on PubMed)

Other Identifiers

RADONK-DILANA-2018

Identifier Type: -

Identifier Source: org_study_id