NCT04830709进行中（未招募）不适用
Prospective Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcome Data in Ovarian Cancer Patients Eligible for First-line Platinum-based Chemotherapy and Intended for BRCA/HRD Testing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 752
- 试验地点
- 90
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
This prospective non-interventional study is intended to generate new data and insights into first-line (1L) treatment of newly diagnosed advanced high-grade epithelial Ovarian cancer (OC) in Germany relevant for patients, physicians and payers. It will capture the influence of 1L Poly ADP ribose polymerase inhibitor (PARPi) maintenance treatment (MTX) on medical routine in Germany, especially on:
- outcome of the 3-steps 1L treatment phase (including surgery, Chemotherapy (CTX) and MTX) including the potential of patients with primary advanced OC to be cured,
- patient's follow-up (FU) during and after MTX therapy,
- patient-reported outcomes (PROs), experiences and needs,
- physician's experience,
- BRCA/HRD and genomic scar testing behavior at diagnosis/during 1L therapy,
- patient selection for different 1L systemic treatment approaches,
- use and safety of drugs,
- treatment sequence in case of recurrence
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Women aged ≥ 18 years
- •Newly diagnosed with primary advanced (FIGO stages III and IV) high-grade epithelial ovarian cancer (including fallopian tube and/or primary peritoneal cancer)
- •For patients who qualify for primary debulking surgery, all surgical procedures must be completed prior to enrollment
- •BRCA mutation test (routinely analyzed germline and/or somatic BRCA1/2 status alone or as part of HRD status determination) already performed or initiated/intended
- •First-line platinum-based chemotherapy planned or a maximum of 3 cycles already received with no sign of disease progression. Total number of cycles after enrollment should be decided individually for each single patient by the treating physician. In case of neoadjuvant chemotherapy and interval debulking surgery, the patient should be enrolled after completion of surgical procedure and at the time of the 1st post-surgery cycle of platinum-based chemotherapy.
- •Willing and able to report PROs electronically
- •Women of childbearing potential must use two forms of reliable contraception according to standard of care
排除标准
- •1. Pregnancy or breast-feeding
- •Current or planned participation in an interventional clinical trial on first-line treatment of OC
- •Current or upcoming systemic treatment of any tumor other than OC
- •Not eligible for platinum-based chemotherapy or early progress during the cycles of first-line platinum-based chemotherapy prior to enrollment
研究组 & 干预措施
Bevacizumab maintenance cohort (BMC)
patients who continue to receive at least one dose of bevacizumab after 1L platinum-based CTX and who have not received PARPi MTX treatment
No maintenance cohort (NMC)
patients who never received any 1L MTX treatment (PARPi or bevacizumab)
PARPi maintenance cohort (PMC)
patients who received at least one dose of PARPi as 1L MTX after 1L platinum-based CTX
结局指标
主要结局
progression-free survival (PFS)
时间窗: date of 1st dose of 1L platinum-based CTX to disease progression (investigator-assessed according to clinical routine) or death of any cause, whichever came first, assessed up to 84 months
The primary outcome is progression-free survival (PFS) defined as time from 1st dose of 1L platinum-based CTX to disease progression (investigator-assessed according to clinical routine) or death of any cause. Methods and intervals for tumor assessments are at the discretion of the treating physician. Details on progression incl. the procedure used to confirm progression (e.g. symptoms, ultrasound, x-ray, CT, MRI) will be captured in the eCRF.
次要结局
- 3rd, 4th, 5th ff. progression-free survival (PFSx = PFS3, 4, 5 ff.)(time from 1st dose of 1L platinum-based CTX to 3rd, 4th, 5th and later disease progression [investigator-assessed according to clinical routine] or death of any cause, whichever came first, assessed up to 84 months)
- Overall survival (OS)(time from 1st dose of 1L platinum-based CTX to death of any cause, assessed up to 84 months)
- Progression-/recurrence-free survival rate(percentage of patients without disease progression/recurrence alive at 2, 3, 5 and 7 years)
- Second progression-free survival (PFS2)(time from 1st dose of 1L platinum-based CTX to second disease progression (investigator-assessed according to clinical routine) or death of any cause, whichever came first, assessed up to 84 months)
- Patient-reported health-related quality of life (HRQoL) - EQ-5D questionnaire(during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months)
- Patient-reported health-related quality of life (HRQoL) - PGI-S questionnaire(during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months)
- Recurrence-free survival (RFS)(time of 1st dose of 1L platinum-based CTX to disease progression (investigator-assessed according to clinical routine) or death of any cause, whichever came first, assessed up to 84 months)
- Time to first subsequent therapy (TFST)(time from 1st dose of 1L platinum-based CTX to the 1st dose of subsequent therapy or death of any cause, whichever came first, assessed up to 84 months)
- Time to second subsequent therapy (TSST)(time from 1st dose of 1L platinum-based CTX to the 1st dose of second subsequent therapy or death of any cause, whichever came first, assessed up to 84 months)
- Time to 3rd, 4th, 5th and later subsequent therapy (TST 3rd, 4th, 5th ff.)(defined as time from 1st dose of 1L platinum-based CTX to the 1st dose of 3rd, 4th, 5th and later subsequent therapy or death of any cause, whichever came first, assessed up to 84 months)
- Patient-reported health-related quality of life (HRQoL) - FACT-O questionnaire(during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months)
- Patient-reported health-related quality of life (HRQoL) - MOSTv2 questionnaire(during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months)
研究者
研究点 (90)
Loading locations...
相似试验
进行中（未招募）
不适用
A Prospective Non-interventional Study to Evaluate Clinical Outcomes of Ribociclib Combined With Endocrine Therapy in Elderly Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in Russian FederationHR+HER2- Advanced Breast CancerNCT06625333Novartis Pharmaceuticals329
招募中
不适用
The Indiana Myeloma RegistryPlasma Cell DyscrasiasNCT03616483Indiana University2,500
已完成
不适用
Prospective Multicentre Non-interventional Study of VANTAS® for the Treatment of Patients With Advanced Prostate CancerProstate CancerNCT01574846Orion Corporation, Orion Pharma142
撤回
不适用
A Study to Evaluate the Clinical Epidemiology of Patients With Heart Failure (HF) in IndiaHeart FailureNCT02047526AstraZeneca
已完成
不适用
Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese OriginGlabellar LinesNCT05089357Galderma R&D250