JOURNAL ONKOLOGIE – STUDIE
DILANA Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy
Rekrutierend
NCT-Nummer:
NCT04094454
Studienbeginn:
Oktober 2019
Letztes Update:
09.01.2020
Wirkstoff:
-
Indikation (Clinical Trials):
Anus Neoplasms
Geschlecht:
Frauen
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Juergen Debus, Juergen Debus
Collaborator:
-
Studienleiter
Principal Investigator
University Hospital Heidelberg
Kontakt
Kontakt:
Phone: +49 6221 568202
E-Mail: nathalie.arians@med.uni-heidleberg.de» Kontaktdaten anzeigen
Kontakt:
Phone: +49 6221 568202
E-Mail: matthias.heafner@med.uni-heidelberg.de» Kontaktdaten anzeigen
Studienlocations (1 von 1)
University Hospital of Heidelberg, Radiation Oncology
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jürgen Debus, Prof. Dr.
Phone: +49-6221-56
Phone (ext.): 8202
E-Mail: juergen.debus@med.uni-heidelberg.de
Adriane Hommertgen
Phone: +49-6221-56
Phone (ext.): 8202
E-Mail: adriane.hommertgen@med.uni-heidelberg.de» Ansprechpartner anzeigen
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jürgen Debus, Prof. Dr.
Phone: +49-6221-56
Phone (ext.): 8202
E-Mail: juergen.debus@med.uni-heidelberg.de
Adriane Hommertgen
Phone: +49-6221-56
Phone (ext.): 8202
E-Mail: adriane.hommertgen@med.uni-heidelberg.de» Ansprechpartner anzeigen
Studien-Informationen
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.
Ein-/Ausschlusskriterien
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
Studien-Rationale
Primary outcome:1. 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 outcome:
1. 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
2. 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
3. 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
4. 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
Studien-Arme
- 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
Geprüfte Regime
- 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
Quelle: ClinicalTrials.gov
