Evaluation of Baseline Characteristics and Therapeutic Management Strategies in Metastatic Cervical Cancer - A Multicenter Retrospective Longitudinal Study
Organizational Data
- DRKS-ID:
- DRKS00031409
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2023-06-01
- Last update in DRKS:
- 2024-01-08
- Registration type:
- Prospective
Acronym/abbreviation of the study
QA-CXmet 2018 – 2022
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
In patients with metastatic cervical cancer usually a Platinum-based combined chemotherapy is recommended, potentially with the addition of a Bevacizumab-maintenance therapy. However, due to the lack of clear evidence in metastatic disease, there is a considerable variation regarding the optimal Platinum (Cisplatin versus Carboplatin) and the optimal drug partner (Paclitaxel, Topotecan, Gemcitabine, Vinorelbine) used in clinical practice. Moreover, recently the addition of a PDL1-Inhibitior (Pembrolizumab) has been approved in a subset of patients (CPS>1) according to a randomized trial, which was able to demon-strate a significantly improved survival when added to conven-tional first line treatment. In order to evaluate the baseline characteristics as well as current management strategies in patient with metastatic disease and the impact of the different systemic treatment regimens, a retrospective analysis of patients with metastatic disease (first-line and recurrent disease) including their outcome will be analyzed in this trial.
Health condition or problem studied
- Free text:
- Metastatic Cervical Cancer
- ICD10:
- C53 - Malignant neoplasm of cervix uteri
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Observation of routine clinical care of patients with metastatic cervical cancer
Endpoints
- Primary outcome:
- The main target criterion is the degree of implementation of the guideline recommendations in the choice of primary systemic treatment: The guideline recommendation includes platinum-containing combination therapy, maintenance therapy with bevacizumab, and the addition of pembrolizumab when appropriate in patients with a CPS>1
- Secondary outcome:
- Progression Free Survival (PFS) Overall Survival (OS) Subsequent Therapies
Study Design
- Purpose:
- Health care system
- Retrospective/prospective:
- Retrospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Longitudinal study
- Study type non-interventional:
- Patient Registry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Hochtaunus-Kliniken gGmbH - Krankenhaus Bad Homburg - Frauenklinik Bad Homburg
- Medical center Evang. Kliniken Essen-Mitte - Gynäkologie & Gynäkologische Onkologie Essen
- University medical center Universitätsklinikum Regensburg - Klinik für Frauenheilkunde und Geburtshilfe Regensburg
- University medical center Universitätsklinikum Erlangen - Universitätsfrauenklinik Erlangen
- Medical center Martin-Luther-Krankenhaus - Klinik für Gynäkologie und Geburtshilfe Berlin
- Medical center HELIOS Dr. Horst Schmidt Kliniken Wiesbaden - Gynäkologie und Gynäkologische Onkologie Wiesbaden
- Medical center GPR Klinikum Rüsselsheim - Frauenklinik Rüsselsheim
- University medical center Universitätsklinikum Essen - Klinik für Gynäkologie und Geburtshilfe Essen
- Medical center RoMed Klinikum Rosenheim - Gynäkologie Rosenheim
- University medical center Technische Universität München, Klinikum rechts der Isar - Frauenklinik und Poliklinik München
- University medical center LMU Klinikum - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe München
- University medical center Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg Marburg
- University medical center Universitätsklinikum Carl Gustav Carus Dresden an der Technischen Universität Dresden Dresden
- University medical center Universitätsklinikum Jena der Friedrich-Schiller-Universität - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe Jena
- University medical center Universitätsklinikum Hamburg-Eppendorf - Klinik und Poliklinik für Gynäkologie Hamburg
- Medical center Oberschwabenklinik, Krankenhaus St. Elisbeth - Frauenklinik Ravensburg
- Medical center Helios-Klinikum Wuppertal Wuppertal
- University medical center Universitätsklinikum Schleswig-Holstein, Campus Lübeck Lübeck
- University medical center Universitätsklinikum Schleswig-Holstein, Campus Lübeck Lübeck
- University medical center Universitätskliniken des Saarlandes Universitätsfrauenklinik und Poliklinik Homburg/Saar
- Medical center Sana Klinikum Offenbach · Klinik für Gynäkologie und Geburtshilfe Offenbach
- University medical center Ludwig-Maximilians-Universität München (LMU) - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe München
- University medical center Universitätsfrauenklinik und Poliklinik am Klinikum Südstadt Rostock Rostock
- University medical center Universitätsklinikum Bonn - Zentrum für Geburtshilfe und Frauenheilkunde Bonn
- University medical center Johannes Gutenberg Universität - Klinik und Poliklinik für Geburtshilfe und Frauenkrankheiten Mainz
- University medical center Universitätsklinikum Ulm - Frauenheilkunde und Geburtshilfe Ulm
- Medical center Klinikum Lippe-Detmold - Frauenklinik Detmold
- Medical center Klinikum am Gesundbrunnen / SLK-Kliniken Heilbronn GmbH Heilbronn
- Medical center Kaiserswerther Diakonie / Florence-Nightingale-Krankenhaus - Klinik für Gynäkologie und Geburtshilfe Düsseldorf
- Medical center Onkologisches Therapiezentrum am Krankenhaus Jerusalem Hamburg
- Other GYNAEKOLOGICUM Bremen Bremen
- University medical center Medizinische Hochschule Hannover (MHH) - Frauenklinik Hannover
Recruitment period and number of participants
- Planned study start date:
- 2023-06-20
- Actual study start date:
- 2023-06-26
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 300
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Histologically proven diagnosis of cervical cancer Diagnosis FIGO Stage IVB or relapsed metastatic disease between 2018 and 2022
Exclusion Criteria
FIGO stage IA1-IVA Non-squamous or Non-adenocarcinoma histology (e.g. neuroendocrine tumors, sarcoma, lymphoma)
Addresses
Primary Sponsor
- Address:
- AGO Research GmbH, AGO StudiengruppeKaiser-Friedrich-Ring 7165185 WiesbadenGermany
- Telephone:
- +49 611 8804 670
- Fax:
- +49 611-8804 6767
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Hochtaunus-Kliniken gGmbH - Krankenhaus Bad HomburgProf. Dr. med. Dominik DenschlagZeppelinstr. 2061352 Bad Homburg v.d.H.Germany
- Telephone:
- +49 6172-14-3166
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- MMF GmbHMarkus KerkmannLindberghweg 13248155 MünsterGermany
- Telephone:
- +49 251 928 730 00
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Hochtaunus-Kliniken gGmbH - Krankenhaus Bad HomburgProf. Dr. med. Dominik DenschlagZeppelinstr. 2061352 Bad Homburg v.d.H.Germany
- Telephone:
- +49 6172-14-3166
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- AGO Research GmbH, AGO StudiengruppeKaiser-Friedrich-Ring 7165185 WiesbadenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Landesärztekammer HessenHanauer Landstraße 15260314 Frankfurt am MainGermany
- Telephone:
- +49-69-97672209
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-02-28
- Ethics committee number:
- 2023-3311-evBO
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-05-31
Other Address Ethics Committee
- Address:
- Ethik-Kommission der Landesärztekammer HessenHanauer Landstraße 15260314 Frankfurt am MainGermany
- Telephone:
- +49-69-97672209
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.laekh.de/fuer-aerztinnen-und-aerzte/rund-ums-recht/ethik-kommission
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-05-31
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry