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NCT Number: NCT02503436

C-PATROL - Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population

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.

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Key information

Conditions

Ovarian Cancer, Hereditary Ovarian Cancer Syndrome Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Diseases Fallopian Tube Neoplasms Fanconi Anemia, Complementation Group D1 Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Amberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 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

  1. To collect and explore real-life data on patient outcomes in terms of Overall Survival (OS)

    Time frame: Date of first documented dose of olaparib to death of any cause, assessed approximately up to 84 months

  2. Time to first subsequent therapy (TFST)

    Time frame: 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

  3. Progression-free survival 2 (PFS2)

    Time frame: 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

  4. Time to second subsequent therapy (TSST)

    Time frame: 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

  5. Time to discontinuation of olaparib monotherapy (TDO)

    Time frame: 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

  6. Assessment of health-related quality of life (HRQoL) in patients participating in the study.

    Time frame: Date of first visit to last visit. HRQoL are collected every 3 months up to 84 months

    Health related quality of life (HRQoL): Assessment of general cancer-associated and specific ovarian cancer associated parameters by use of standardized HRQoL questionnaires:

    • Functional assessment of Cancer Therapy for Patients with Ovarian Cancer (FACT-O)
    • Functional Assessment of Chronic Illness - Fatigue (FACIT-Fatigue)
    • Functional Living Index - Emesis (FLIE)

  7. Safety of Olaparib: collection of Adverse Events (AE)

    Time frame: Date of first documented dose of Olaparib to last visit, assessed approximately up to 84 months

    Type and frequeny of adverse event (AE), intensity, causal relationship to olaparib, outcome, seriousness, management of adverse event

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: C-PATROL

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2015
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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