Clinical trial NCT02503436: C-PATROL - Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population
Official title: C-PATROL - a Single Arm, Prospective Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer, Hereditary Ovarian Cancer Syndrome
Keywords: Ovarian Cancer, Fallopian Tube Cancer, primary peritoneal cancer, BRCA1 Gene, BRCA2 Gene
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-07-21
Enrollment: 276
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 300 patients in 80 sites (approx. 40 hospitals and 40 outpatient practices) in Germany. Each site should enrol 2-30 patients

Brief summary: The main objective of the proposed non-interventional study is to obtain real-world effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer Gene(s) mutation positive) platinum sensitive relapsed (PSR) ovarian cancer in German hospitals and outpatient practices treated with olaparib.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Women aged ≥ 18 years
* Patients with platinum sensitive relapsed high grade epithelial ovarian cancers (including primary peritoneal and/or fallopian tube cancer). (Platinum sensitive disease is defined as disease progression ≥6 months after completion of their last dose of platinum based chemotherapy. Patients must be currently in response to platinum-based chemotherapy. For the last chemotherapy course immediately prior to enrolment on the study, patients must be, in the opinion of the investigator, in response (partial or complete), following completion of this chemotherapy course.
* Documented BRCA mutations (germline and/or somatic mutation in BRCA1 (Breast Cancer gene 1) and/or BRCA2 (Breast Cancer gene 2) that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function))
* Patients should be in line with the specifications mentioned in the German LYNPARZA (olaparib) SmPC (Summary Product Characteristics) for hard capsules or tablets.
* Patients are able to read and understand German, English, Turkish or Arabic

Exclusion Criteria:

* Known hypersensitivity to olaparib or any of the excipients of the drug
* Patients who have started olaparib monotherapy for more than 14 days before giving their informed consent
* Pregnancy or breast feeding

Primary outcomes:
measure: To assess clinical effectiveness of olaparib maintenance monotherapy by assessment of progression free survival (PFS) in patients with BRCAm+ ovarian cancer. Methods and time intervals for tumor assessment depend on the investigator's decision.
timeFrame: Date of first documented dose of olaparib to the date of progression (as judged by the investigator) or death (of any cause) whichever occurred before, assessed approximately up to 84 months
Secondary outcomes:
measure: To collect and explore real-life data on patient outcomes in terms of Overall Survival (OS)
timeFrame: Date of first documented dose of olaparib to death of any cause, assessed approximately up to 84 months
measure: Time to first subsequent therapy (TFST)
timeFrame: Date of first documented dose of olaparib to date of first administration of first subsequent therapy or death if this occurs before commencement of first subsequent treatment, assessed approximately up to 84 months
measure: Progression-free survival 2 (PFS2)
timeFrame: Date of first administration of first subsequent therapy to date of progression as assessed by the investigator or death, assessed approximately up to 84 months
measure: Time to second subsequent therapy (TSST)
timeFrame: Date of first documented dose of olaparib to date of first administration of second subsequent therapy or death if this occurs before commencement of second subsequent treatment, assessed approximately up to 84 months
measure: Time to discontinuation of olaparib monotherapy (TDO)
timeFrame: Date of first documented dose of olaparib montherapy to date of last documented dose of olaparib monotherapy or death whichever occurred before, assessed approximately up to 84 months
measure: Assessment of health-related quality of life (HRQoL) in patients participating in the study.
timeFrame: Date of first visit to last visit. HRQoL are collected every 3 months up to 84 months
measure: Safety of Olaparib: collection of Adverse Events (AE)
timeFrame: Date of first documented dose of Olaparib to last visit, assessed approximately up to 84 months
Other outcomes:
Locations:
city: Amberg
country: Germany
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Bad Homburg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Bottrop
country: Germany
facility: Research Site
city: Brandenburg an der Havel
country: Germany
facility: Research Site
city: Braunschweig
country: Germany
facility: Research Site
city: Bremen
country: Germany
facility: Research Site
city: Chemnitz
country: Germany
facility: Research Site
city: Coburg
country: Germany
facility: Research Site
city: Donauwoerth
country: Germany
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Duesseldorf
country: Germany
facility: Research Site
city: Duisburg
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Esslingen am Neckar
country: Germany
facility: Research Site
city: Eutin
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Freiburg im Breisgau
country: Germany
facility: Research Site
city: Fuerstenwalde
country: Germany
facility: Research Site
city: Georgsmarienhuette
country: Germany
facility: Research Site
city: Halle (Saale)
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Heidenheim an der Brenz
country: Germany
facility: Research Site
city: Hildesheim
country: Germany
facility: Research Site
city: Homburg/Saar
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Karlsruhe
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Kempten
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Koeln
country: Germany
facility: Research Site
city: Krefeld
country: Germany
facility: Research Site
city: Kulmbach
country: Germany
facility: Research Site
city: Landshut
country: Germany
facility: Research Site
city: Luebeck
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Moenchengladbach
country: Germany
facility: Research Site
city: Muenchen
country: Germany
facility: Research Site
city: Muenster
country: Germany
facility: Research Site
city: Mutlangen
country: Germany
facility: Research Site
city: Nuernberg
country: Germany
facility: Research Site
city: Oberhausen
country: Germany
facility: Research Site
city: Osnabrueck
country: Germany
facility: Research Site
city: Paderborn
country: Germany
facility: Research Site
city: Plauen
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Rosenheim
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Saarbruecken
country: Germany
facility: Research Site
city: Schwerin
country: Germany
facility: Research Site
city: Singen
country: Germany
facility: Research Site
city: Solingen
country: Germany
facility: Research Site
city: Stralsund
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Traunstein
country: Germany
facility: Research Site
city: Troisdorf
country: Germany
facility: Research Site
city: Tuebingen
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Wolfsburg
country: Germany
facility: Research Site
city: Wuerzburg
country: Germany
facility: Research Site
Study officials:
References: