JPRN-jRCT2031220203
Recruiting
Phase 2
A Randomized Study of Paclitaxel - Carboplatin followed by maintenance Niraparib compared to Paclitaxel - Carboplatin - Bevacizumab followed by maintenance Niraparib+Bevacizumab in Patients With Advanced Ovarian Cancer, Following a Front-Line Complete Cytoreductive Surgery - NIRVANA-1
Hasegawa Kosei0 sites24 target enrollmentJuly 8, 2022
Conditionsovarian cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- ovarian cancer
- Sponsor
- Hasegawa Kosei
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female patient \>\= 18 years of age.
- •2\. Signed informed consent and ability to comply with treatment and follow\-up.
- •3\. Patient with newly diagnosed,
- •a. Ovarian cancer, primary peritoneal cancer and/or fallopian\-tube cancer,
- •b. Histologically confirmed (based on local histopathological findings):
- •\- high grade serous or
- •\- high grade endometrioid (grade 2 and 3\) or
- •\- other epithelial non mucinous and non\-clear cell ovarian cancer in a patient with germline BRCA1 or 2 deleterious mutation
- •c. At an advanced stage: FIGO stage IIIA to IIIC of the 2018 FIGO classification.
- •4\. Patient having undergone frontline, complete cytoreductive surgery (i.e. no visible residual disease): The patient will be considered eligible once the ESGO Quality Assurance in Ovarian Cancer Surgery will have been filled out and validated.
Exclusion Criteria
- •1\. Patient with clear cell adenocarcinoma or carcinosarcoma, non\-epithelial origin of the ovarian tumor, the fallopian tube or the peritoneal tumor (i.e. germ cell tumors).
- •2\. Ovarian tumor of low malignant potential (e.g. borderline tumor), or mucinous carcinoma.
- •3\. Patient with a diagnosis, detection, or treatment of another type of cancer \=\< 3 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin and cervical cancer in situ that has been definitively treated, and synchronous stage 1, grade 1 endometrial cancer).
- •Patient with history of primary triple negative breast cancer may be eligible provided she completed her definitive anticancer treatment more than 3 years ago and she remains breast cancer disease free prior to start of study treatment.
- •4\. Patient with synchronous high grade serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium is not eligible.
- •5\. Patient with myelodysplastic syndrome/acute myeloid leukemia history.
- •6\. Patient receiving radiotherapy within 6 weeks prior to study treatment.
- •7\. Previous allogenic bone marrow transplant.
- •8\. Any previous treatment with PARP inhibitor.
- •9\. Administration of other simultaneous chemotherapy drugs \- except during a HIPEC procedure with cisplatin at PDS, any other anticancer therapy or anti\-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroid antiemetics).
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
A Randomized Study of Paclitaxel – Carboplatin followed by maintenance Niraparib compared to Paclitaxel – Carboplatin – Bevacizumab followed by maintenance Niraparib + Bevacizumab in Patients With Advanced Ovarian Cancer Following a Front-Line Complete Cytoreductive SurgeryKCT0007855ational Cancer Center20
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