Clinical trial NCT03958357: Post Market Clinical Follow-up Study Venezia
Official title: Multi-center Prospective Observational Clinical Follow-Up Study Advanced Gynecological Applicator - Venezia Configuration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Cervix
Uterus
Vagina
Cancer
Gynecology
Cervical cancer
External beam radiation therapy
Brachytherapy
Lead sponsor: Nucletron Operations BV
Sponsor class: INDUSTRY
Collaborators: name: Factory CRO
First posted: 2019-05-22
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be included in this study at 5 centers: 3 centers in Europe and 2 centers in the United States. For all participants chemoradiation treatment is planned with curative intent. Since chemoradiation including external beam radiation therapy and brachytherapy is standard of care for these patients, patients are selected according to the clinical practice guidelines of the clinical center. The treating radiation oncologist decides which patients will undergo the brachytherapy with the Advanced Gynecological Applicator Venezia Configuration.

Brief summary: The investigational device is the Advanced Gynecological Applicator (AGA) Venezia configuration, an applicator to treat locally advanced stage cervical cancer. The goal of the study is to assess the performance and the unknown risks or complications of the AGA Venezia configuration during clinical use of the applicator.

Detailed description: This is a multi-center, prospective, post-market clinical follow-up study to assess the performance and the unknown risks or complications of the Advanced Gynecological Applicator (AGA) Venezia configuration during clinical use of the applicator. The AGA Venezia configuration is a CE-marked, FDA approved and commercially available product. The AGA Venezia configuration is a gynaecological applicator for intracavitary and interstitial brachytherapy. The radiation oncologist can use it for treatment of cancers in the vagina, cervix and uterus. Forty (40) participants will be included in this study at 5 sites: 3 centers in Europe and 2 centers in the United States.

Eligibility criteria: Inclusion Criteria:

* Patients with locally advanced cervical cancer stage IB to IVA
* Patients eligible for brachytherapy according to the criteria of the treating radiation oncologist and center guidelines
* Patients that are eligible to undergo brachytherapy with the Advanced Gynecological Applicator Venezia Configuration according to the criteria of the treating radiation oncologist
* Patient is able to understand and has voluntarily signed and dated the Ethics Committee approved informed consent form prior to initiation of any screening or study-specific procedures.

Exclusion Criteria:

* Patients that have been treated or will be treated for cancer other than cervical cancer.
* Advanced stage cervical cancer patients who have been treated with pelvic radiotherapy, incl. brachytherapy, before.
* Patients younger than 18 years at the time of diagnosis.

Primary outcomes:
measure: Performance of the AGA Venezia configuration applicator as assessed by the 'Applicator Performance Questionnaire'
timeFrame: Within one week after each individual insertion. No change is assessed. The procedure is performed per hospital standard. On average, the procedure and applicator insertions are performed twice.
Secondary outcomes:
measure: Risks and/or complications of the AGA Venezia configuration applicator as assessed by the 'Risks and Complications Questionnaire'
timeFrame: Immediately after each insertion and followed up during the first follow-up visit, typically three months after the last insertion. The procedure is performed per hospital standard. On average, the procedure and applicator insertions are performed twice.
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
city: Munich
country: Germany
facility: Ludwig-Maximilians - University of Munich
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht
Study officials:
affiliation: UMC Utrecht
name: Ina Jurgenliemk-Schulz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University Vienna
name: Alina Sturdza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Robert Hobbs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Case Western
name: Elizabeth Harris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ludwig-Maximilians - University of Munich
name: Stefanie Corradini, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Ina Jurgenliemk-Schulz, MD, PhD
role: STUDY_CHAIR
affiliation: Medical University Vienna
name: Christian Kirisits, Prof. Dr.
role: STUDY_CHAIR
References: