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临床试验/NCT02569983
NCT02569983已完成不适用

A Multi-centre Prospective Pilot Observational Cohort Study to Assess Quality of Life and Survival After Surgery for Advanced Ovarian Cancer

University of Birmingham14 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
235
试验地点
14
主要终点
Quality of life

研究概览

简要总结

The primary aims of the SOCQER-2 study are to describe any impact on short (6 weeks), medium term (6, 12 months) and long term (18 months, 24 months) PRO/quality of life using validated questionnaires in patients undergoing standard or extensive surgery for suspected or confirmed Stage III/IV ovarian cancer and to describe progression free survival (PFS) in these patients.

详细描述

BACKGROUND

The cornerstones of treatment for advanced ovarian cancer are surgical cytoreduction and systemic therapy. The aim of surgery is the maximal cytoreduction of all visible disease, ideally reaching a total macroscopic tumour clearance.

Whilst most gynaecological oncologists accept that surgical procedures needed to achieve complete cytoreduction are on a continuum, a Cochrane review summarises types of ovarian cancer surgery as follows:

  • standard surgery
  • radical surgery
  • supra-[ultra-] radical surgery

Several observational studies and two systematic reviews of non-randomised studies have shown an association between the amount of residual disease following surgery and survival, controlling for various confounding factors. However, the systematic reviews identified no randomised control trials directly comparing standard surgery versus extensive surgery. A National Institute for Health and Care Excellence (NICE) Interventional Procedures Overview found a number of retrospective observational studies comparing extensive with standard surgery, and found that women who underwent extensive surgery had better survival to those undergoing standard surgery, thus suggesting that the utilisation of surgical procedures to achieve complete cytoreduction may overcome disease aggressiveness. Incidence of serious complications, however, was higher in patients undergoing extensive surgery. However, there were several confounding factors e.g patients with good performance status are more likely to be selected to undergo extensive surgery. Equally, patients with lesser disease burden can have complete removal of tumour by standard surgery alone.

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

入选标准

  • Patients with suspected or confirmed ovarian cancer with macroscopic spread beyond the pelvis (FIGO stage III-IV), determined through pre-operative clinical assessment or imaging
  • Patient listed for primary debulking surgery or neo-adjuvant chemotherapy with the intent of interval debulking surgery

排除标准

  • Ovarian cancer relapse
  • Progression of cancer
  • Informed consent not obtained.
  • Primary chemotherapy with no intent of interval surgery
  • Actively receiving treatment for another cancer
  • Secondary cancers <5years or relapsed secondary cancer in the past

结局指标

主要结局

Quality of life

时间窗: up to 2 years

次要结局

  • Progression free survival(up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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