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Efficacy and Adverse Effects of Olaparib in Ovarian Cancer.

NCT04699006 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 245

Last updated 2023-06-15

No results posted yet for this study

Summary

Ovarian cancer is the second fatal gynecological cancer. More than 70% of ovarian cancer patients are diagnosed as advanced. Olaparib is the first oral poly adenosine diphosphate-ribose polymerase inhibitor (PAPPi) approved by the U.S. Drug Administration (FDA) in December 2014. It can be used as a maintenance treatment for adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer after platinum-containing chemotherapy has achieved complete or partial remission. At present, most studies based on olaparib are randomized controlled trials (RCTs). Because RCTs often have strict inclusion and exclusion criteria and they are implemented in a highly standardized environment. Its internal validity is high, but the research results may not be able to be extrapolated to practice. This study is a prospective real world study. In this study, based on the modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), we evaluate the use of olaparib in patients with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer in the progression-free survival (PFS), overall survival (OS), and objective control rate (ORR), etc. At the same time, the safety and tolerability of olaparib and the impact on the quality of life of patients are evaluated. Finally, we analyze the results as a supplement to the conclusions of randomized controlled trials to provide better guidance for patients.

Conditions

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Qiling Li, MD,PhD · First Affiliated Hospital Xi'an Jiaotong University

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2024-01-01
Completion
2026-01-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04699006 on ClinicalTrials.gov