Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT04507841|
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : August 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Niraparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer|
|Actual Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||July 1, 2022|
Experimental: Niraparib group
Niraparib was used in patients with newly diagnosed ovarian cancer before any treatment. The daily dose (e.g. 200 mg is 2 capsules of 100 mg) should be strictly controlled according to the experimental design.
Niraparib was used as 100mg capsules once a day since cycle 1 / day 1. The daily dose (e.g. 200 mg is 2 capsules of 100 mg) should be strictly controlled according to the experimental design. Patients should take medicine regularly every day under the guidance of doctors (the best in the morning). The patient must swallow all the capsules completely and do not chew the capsules. You may drink water or eat when taking medicine.
- R0 resection rate [ Time Frame: 3-month ]the percentage of patients received R0 resection after Niraparib neoadjuvant treatment.
- Overall Response Rate (ORR) [ Time Frame: 3-month ]Overall Response Rate according to RECIST1.1. ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of diameters (SoD) of target lesions.
- Disease Control Rate [ Time Frame: 3-month ]Disease control rate is defined as the proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1 and CA125 according to GCIC guidelines
- Complete pathologic response rate [ Time Frame: 3-month ]Complete pathologic response rate is measured according to Miller-Panye system.
- Progression Free Survival (PFS) [ Time Frame: 3-year ]PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Overall survival (OS) [ Time Frame: 5-year ]Overall survival. OS is defined as the time from the study enrollment to death due to any cause.
- Quality of Life (QOL) measures using Functional Assessment of Cancer Therapy (FACT- ovarian cancer) [ Time Frame: 5 years ]To evaluate quality of life (QOL) for the subjects undergoing this treatment, using validated tools. QOL will be assessed every 3 months during treatment course. [Functional Assessment of Cancer Therapy - Ovarian Cancer questionnaire (score range from 0 to 160. Higher scores represent better quality of life.
- Patient report outcome, EQ-VAS [ Time Frame: 3 years ]life quality assessment. EQ-VAS, EuroQol-visual analogue scales. Score range from 0 [worse outcome] to 10 [better outcome]).
- Rate of treatment interruption and termination [ Time Frame: 5 years ]The rate of treatment interruption and termination caused by patients' intolerance of treatment side effects and other reasons;
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 5 years ]To further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in patients with stage III, all stage IV ovarian cancer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04507841
|Contact: Qinglei Gao, MD. PhDemail@example.com|
|Wuhan, Hubei, China, 430000|
|Contact: Qinglei Gao, MD. PhD +86-27-83662681 firstname.lastname@example.org|
|Principal Investigator:||Qinglei Gao, MD. PhD||Tongji Hospital|