Outcomes of First-line Olaparib Mono-maintenance therapy-a Multicenter, Retrospective Study Using Data From Real-world Clinical Setting
NCT ID: NCT05153603
Last Updated: 2021-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2022-04-30
2022-12-31
Brief Summary
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Detailed Description
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The secondary objectives are to evaluate the outcomes of olaparib-based maintenance therapy by: 1) 2-yr PFS rate; 2) median PFS; 3) median Time to First Subsequent Therapy or death (mTFST) ; 4) post-progression treatment after first progression; 5) reason for olaparib dose adjustment, dose interruptions, and dose discontinuations; 6) Reason for use of concomitant therapy.
The exploratory objective is to evaluate the status quo of genetic testing, R0 resection and related outcomes.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Olaparib mono-maintenance therapy group
Olaparib monotherapy in clinical practice and will be conducted in patients with tBRCAwt newly diagnosed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy following the standard of care from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) at tertiary-referral university hospitals and main cancer centers in China.
Olaparib mono-maintenance therapy
Olaparib mono-maintenance therapy in patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III-IV) ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer is defined as drug exposure. At least one dose of olaparib tablets monotherapy as maintenance therapy will be required.
Interventions
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Olaparib mono-maintenance therapy
Olaparib mono-maintenance therapy in patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III-IV) ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer is defined as drug exposure. At least one dose of olaparib tablets monotherapy as maintenance therapy will be required.
Eligibility Criteria
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Inclusion Criteria
* Female Patients must be ≥18 years old at diagnosis.
* Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III-IV) ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer and received olaparib from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required).
* Patients must have a tumor BRCA testing result which is tBRCAwt, defined as tumor BRCA wild type (patients without evidence of BRCA 1 and/or BRCA 2 deleterious or suspected deleterious mutations).
* Patients who have completed first-line platinum-based chemotherapy and were in clinical complete response (CR) or in partial response (PR).
* Patients who were still in CR or PR before receiving maintenance therapy.
* Patients who received at least one dose of olaparib tablets monotherapy as maintenance therapy within three months after platinum-based chemotherapy and without disease progression.
Exclusion Criteria
* Patient with multiple primary cancers as reported in EMR.
* Concomitant any anti- cancer therapy (chemotherapy, immunotherapy, hormonal therapy (Hormone replacement therapy (HRT) is acceptable), radiotherapy, biological therapy or other novel agent) during Olaparib maintenance.
* Any previous treatment with PARP inhibitor.
* Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
* Patients with symptomatic uncontrolled brain metastases.
* Any other concerns related to decreased efficacy and safety of maintenance therapy.
18 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Principal Investigators
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Zhong-qiu Lin, MD, PhD,Professor
Role: STUDY_CHAIR
Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Jing Li, MD, PhD,Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Central Contacts
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Other Identifiers
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ESR-20-20889-02
Identifier Type: -
Identifier Source: org_study_id