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