Status:
UNKNOWN
First-line Olaparib Combined With Bevacizumab Maintenance Therapy
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
18+ years
Brief Summary
Four phase III trials in ovarian cancer consistently showed that front-line poly(ADP-ribose) polymerase (PARP) inhibition can significantly improve progression-free survival. Based on these findings, ...
Detailed Description
The main objective is to evaluate the outcome of olaparib plus bevacizumab combination maintenance therapy by proportion of patients alive and progression free at 1 year (1-yr PFSrate) We hypothesize ...
Eligibility Criteria
Inclusion
- 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 and plus bevacizumab 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 plus bevacizumab maintenance therapy within three months after platinum-based chemotherapy and without disease progression
Exclusion
- 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 plus bevacizumab maintenance therapy.
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05440578
Start Date
June 1 2022
End Date
December 1 2022
Last Update
July 1 2022
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