Ovarian Neoplasms Clinical Trial
Official title:
Outcomes of First-line Olaparib Mono-maintenance Therapy in Newly Diagnosed Ovarian Cancer Patients With tBRCA Wild-type Tumors: a Realworld Study
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, current clinical guidelines recommend the olaparib + bevacizumab combination as a maintenance therapy for ovarian cancer patients with BRCA1/2 wild-type or unknown mutation status who have a complete response (CR)/ partial response (PR) after completing bevacizumab-containing first-line therapy. However, bevacizumab is not a NATIONAL MEDICAL PRODUCTS ADMINSTRATION（NMPA）-approved agent for ovarian cancer patients. In this setting, olaparib mono-maintenance therapy has been implemented among patients with BRCA-wild type tumors in clinical practice in China.
The main objective is to evaluate the outcome of olaparib-based maintenance therapy by proportion of patients alive and progression free at 1 year (1-yr PFS rate) We hypothesize that olaparib monotherapy could be beneficial for tBRCAwt high-grade serous ovarian cancer (HGSOC) patients who are treated with platinum-based first-line chemotherapy. 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03371693 -
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT03648489 -
Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)
|
Phase 2 | |
| Active, not recruiting |
NCT02950064 -
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
|
Phase 1 | |
| Completed |
NCT02569983 -
The SOCQER-2 Study Surgery in Ovarian Cancer - Quality of Life Evaluation Research
|
||
| Withdrawn |
NCT02243059 -
Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer
|
Phase 4 | |
| Terminated |
NCT02055690 -
PAZOFOS: Phase Ib and Phase II Trial of Pazopanib +/- Fosbretabulin in Advanced Recurrent Ovarian Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01719926 -
Phase I Platinum Based Chemotherapy Plus Indomethacin
|
Phase 1 | |
| Completed |
NCT00415181 -
Pharmacogenomics of Paclitaxel in Ovarian Cancer
|
N/A | |
| Completed |
NCT00243685 -
Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis
|
Phase 2/Phase 3 | |
| Recruiting |
NCT01789229 -
Establishment of a Tumor Bank for Tissue Samples
|
||
| Completed |
NCT00069160 -
Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer
|
Phase 2 | |
| Completed |
NCT00772863 -
Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT00046800 -
Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT00035100 -
EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
|
Phase 2 | |
| Terminated |
NCT00034372 -
Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-Chemotherapy Consolidation for Ovarian Carcinoma
|
Phase 2 | |
| Completed |
NCT00001272 -
A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients
|
Phase 1 | |
| Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 | |
| Recruiting |
NCT05001282 -
A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)
|
Phase 1/Phase 2 | |
| Completed |
NCT02227654 -
Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors
|
N/A | |
| Not yet recruiting |
NCT04055038 -
Efficacy of Platinum-based Chemotherapy in Platinum-resistant Ovarian Cancer) (EPITOC)
|
Phase 2/Phase 3 |