Identifikation of parameters for the development of a Score to predict the non-compliance of patients with recurrent ovarian cancer undergoing a routine therapy with Ovastat(R). A non-interventional observation trial (NIS)
Organizational Data
- DRKS-ID:
- DRKS00011344
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2016-11-21
- Last update in DRKS:
- 2023-11-07
- Registration type:
- Retrospective
Acronym/abbreviation of the study
SCORE trial
URL of the study
Brief summary in lay language
Patients suffering from ovarian cancer often interrupt their chemotherapy after only one or two cycles of therapy. In this cases it is unlikely that patients will benefit from the therapy. The aim of this trial is to to develop a score for the prediction of an early therapy discontinuation based on data from questionaires and clinical examinations. This data will be collected before the therapy starts. Once developed, the score can support physicians and patients to decide for or against another line of chemotherapy.
Brief summary in scientific language
Based on routine clinical examintions ( anamnesis, general condition, laboratory parameters ) and supported by different questionaires concerning previous therapy, expectation on therapy, symptoms of disease (MOST questionaire) and stance on complementary medicine (AKKOM questionair) data from 500 patiens with recurrent ovarian cancer are collected in a non interventional trial. A treatment with treosulfan (Ovastat(R)) was planned before entering the trial for all patients included. The aim of the trial is to explore the correlations between the collected data and an early discontinuation of therapy and to develop a score based on this correlations. The decision for or against a treosulfan therapy can be supported by the Score so that in case of a high probability of early therapy discontinuation the stress for the patient by another chemotherapy line can be avoided.
Health condition or problem studied
- ICD10:
- C56 - Malignant neoplasm of ovary
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Patients suffering from reccurend ovarian cancer are treated with treosulfan in a non-interventional trial. As treosulfan is approved and can be administered in an intravenous and an oral formulation as well, treosulfan can be used in this trial in both formulations according to patients and physicians preference. The dosage is: i.v. treosulfan: 7.000 mg/m2,q3w oder q4w (both time intervalls are according to approval) - alternative : treosulfan oral, 400-600mg/m2 per day for 28 days, q56d - in a recent trial, currently in print, Sehouli et.al. could prove equal efficacy for oral and intravenous treosulfan. [A phase III, open label, randomized multicenter controlled trial of oral versus intravenous Treosulfan in heavily pretreated recurrent ovarian cancer: A study of the North-Eastern German Society of Gynecological Oncology (NOGGO); Journal of Cancer Research and Clinical Oncology in press] before starting the treatment, Patients answer questionaries concerning cancer realted questtions (MOST questionary), therapyexpierience and - expectation and attitude towards complementary medicine (AKKOM questionary).
Endpoints
- Primary outcome:
- Identifikation of parameters for the development of a Score to predict the non-compliance of patients with recurrent ovarian cancer undergoing a routine therapy with treosulfan (Ovastat(R)).
- Secondary outcome:
- evalution of preference for a i.v. or oral therapy and reasons for the decision - dose intensity and duration of treatment - reasons for therapy discontinuation and dose modification - tolerability - concurrent medication - influence of comarbidity and age on therapy efficacy and and intensity - determination of objective response (PR+CR) and clinical Benifit (CR+PR+SD) - median progressiondree Survival (PFS) - PFS rate after one year - Time to treatment failure (TTF) - one Year survival rate - Subgroup analyses: age <65 and age>65 - previous and subsequent therapies - relation beteween Therapy compliance and efficacy
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Doctor's practice Westerstede
- Medical center Friederikenstift Hannover
- University medical center Freiburg im Breisgau
- Doctor's practice Mannheim
- Medical center Klinikum Kassel GmbH Kassel
- Doctor's practice Leer
- Medical center Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Villingen-Schwenningen
- Medical center Ortenau Klinikum Offenburg-Gengenbach Offenburg
- Medical center Städt. Klinikum Karlsruhe Karlsruhe
- Doctor's practice Hannover
- Doctor's practice Stolberg
- Medical center Kreiskrankenhaus Torgau "Johann Kentmann" gGmbH Torgau
- Doctor's practice Naunhof
- Medical center Agaplesion Diakonieklinikum Rotenburg GmbH Rotenburg/Wümme
- Doctor's practice Nordhorn
- Doctor's practice Würselen
- Doctor's practice Remscheid
- Medical center Klinikum Ansbach Ansbach
- University medical center Universitätsklinikum Jena Jena
- Medical center Kreiskrankenhaus Freudenstadt Freudenstadt
- Medical center Elisabeth Krankenhaus Essen Essen
- Medical center Medius Kliniken Ostfildern Ruit GmbH Ostfildern
- University medical center Universitätsklinikum Schleswig-Holstein Kiel
- Medical center Medius Klinik Nürtingen Nürtingen
- University medical center Universitätsklinikum Ulm Ulm
- Doctor's practice Mühlheim an der Ruhr
- University medical center Charité - Universitätsmedizin Berlin Berlin
- Medical center Kommunalunternehmen Klinikum Augsburg Augsburg
- Medical center Helios Klinikum Krefeld Krefeld
- Medical center Diako Ev. Diakonie-Krankenhaus gGmbH Bremen
- Doctor's practice Bielefeld
- University medical center Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden Dresden
- Medical center Klinikum Osnabrück Osnabrück
- University medical center Greifswald
- Medical center Franziskus Hospital Bielefeld
- Medical center Klinikverbund Südwest Böblingen
- Other Apel Medconsult GmbH Witterda
- Medical center Evangelisches Krankenhaus Bergisch Gladbach Bergisch Gladbach
- Doctor's practice Bonn
- Other OnkoLog Moers GbR Moers
- Doctor's practice Heidelberg
- Medical center Agaplesion Ev. Klinikum Schaumburg Obernkirchen
- University medical center Universität des Saarlandes Campus Saarbrücken Homburg
- University medical center UKSH Lübeck
- University medical center Universitätsmedizin Göttingen
- Doctor's practice Dresden
- Doctor's practice Donauwörth
- Doctor's practice München
- Medical center Evangelisches Klinikum Bethel gGmbH Bielefeld
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2016-08-15
- Planned study completion date:
- 2023-11-24
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 500
- Final Sample Size:
- 194
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - patients with recurrent ovarian cancer who have decided to undergo a chemotherapy with treosulfan - patients aged 18 years or older - patients who are able to answer questionaires in german language - willingness to answer questionaires - before entering the trial informed consent and data privacy statement must be signed by the patient
Exclusion Criteria
contemporaneous partizipation in a different clinical trial during the time of treatment or within the last 30 days. - hypersensitivity to treosulfan - patients with missing or reduced legal competence - patients in an instituion due to a legal or governmental order - pregnant and breast-feeding women - no anamnesis form (contains only data collected in routine anamnesis)
Addresses
Primary Sponsor
- Address:
- medac Gesellschaft für klinische Spezialpräparate mbHTheaterstraße 622880 WedelGermany
- Telephone:
- +49 4103 8006 0
- Fax:
- +49 4103 8006 100
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medac.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- medac Gesellschaft für klinische Spezialpräparate mbHDr. Insa WolfTheaterstraße 622880 WedelGermany
- Telephone:
- +49 4103 8006 9479
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medac.de
Contact for Public Queries
- Address:
- medac Gesellschaft für klinische Spezialpräparate mbHDr. Insa WolfTheaterstraße 622880 WedelGermany
- Telephone:
- +49 4103 8006 9479
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medac.de
Principal Investigator
- Address:
- medac Gesellschaft für klinische Spezialpräparate mbHDr. Insa WolfTheaterstraße 622880 WedelGermany
- Telephone:
- +49 4103 8006 9479
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medac.de
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- medac Gesellschaft für klinische Spezialpräparate mbHTheaterstraße 622880 WedelGermany
- Telephone:
- +49 4103 8006 0
- Fax:
- +49 4103 8006 100
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medac.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Charité – Universitätsmedizin BerlinCharitéplatz 110117 BerlinGermany
- Telephone:
- (+49)30-450517222
- Fax:
- (+49)30-450517952
- 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:
- 2016-01-04
- Ethics committee number:
- EA2/005/16
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2016-01-28
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:
- Beobachtungsplan
- 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