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临床试验/NCT03268876
NCT03268876进行中(未招募)不适用

The INFLUENCE of Cytoreduction on Patient Reported Outcomes in Patients With Epithelial Ovarian Cancer

Haukeland University Hospital3 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
70
试验地点
3
主要终点
Mean Global Health Score

研究概览

简要总结

Based on an improved understanding of how the extent of successful cytoreduction is influenced both by inherent tumor biological characteristics as well as the aggressiveness of the surgical approach this project aims to better define the value of cytoreduction and to use the knowledge gained to develop more individualized therapy and follow-up. This will be achieved through a translational biomedical research approach. Due to the research group's traditions clinical phenotyping, biomarker identification, and clinical trials will be the focus.

详细描述

The patients will be recruited at their follow-up appointment after their surgery. At this consultation the patient will be informed about the final diagnosis and extent of disease and a plan for their further chemotherapeutic treatment will be developed. All patients will be offered carboplatin AUC 5 and paclitaxel 175mg/m2 q3w for 6 cycles [+ bevacizumab 7.5mg/kg q3w for 18 cycles in high-risk women of recurrence (IIIc not maximal debulked with a rest tumor of >1 cm2 and stage IV)]. In they fulfill the inclusion criteria and agree the inform consent formula will be signed. During the screening period the study team will secure that the necessary information needed is available and study specific test and analysis will be undertaken. After inclusion the study specific consultations will be scheduled coinciding with the patient regular appointments for treatment and follow-up. The patients will be followed at predetermined time points (after finalizing the chemotherapy; and every 3 months thereafter for 2 years).

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 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Epithelial ovarian cancer
  • Stage > II
  • ECOG < II
  • Treated with primary surgery followed by chemotherapy
  • Willing to participate and to sign the informed consent

排除标准

  • < 18 years old
  • Borderline and non-epithelial ovarian tumors
  • Stage < II
  • Advanced ovarian cancer submitted to neoadjuvant chemotherapy
  • Pregnancy
  • Severe cardiopulmonary disease
  • Patients participating in QoL intervention studies

结局指标

主要结局

Mean Global Health Score

时间窗: 2 years

Is there a relationship between QOL score and immunologic profiling in biological samples?

次要结局

未报告次要终点

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (3)

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