Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer: A GO SOAR Led Study (GO SOAR2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- NHS Grampian
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
To compare patient outcomes following interval and delayed cytoreductive surgeries and no surgery (neoadjuvant chemotherapy alone) and international variations in access to cytoreductive surgeries in women with advanced stage ovarian cancer.
详细描述
Standard of care in patients with advanced ovarian cancer is primary cytoreductive surgery followed by chemotherapy. Neoadjuvant chemotherapy and interval cytoreductive surgery is an alternative in selected patients. Most data exist with interval cytoreductive surgery following 3-4 cycles of chemotherapy, however, some patients experience a delay. So far, the impact of delayed cytoreductive surgery (following >5 cycles of chemotherapy) on patient outcomes is poorly defined. There is also a paucity of data in women who undergo no surgery (>5 cycles of chemotherapy alone) and factors influencing international discrepancies in access to cytoreductive surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Women with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) or delayed (>5 cycles of chemotherapy) cytoreductive surgeries or no cytoreductive surgery (>5 cycles of chemotherapy alone.
排除标准
- •Women undergoing recurrent cytoreductive surgery.
结局指标
主要结局
overall survival
时间窗: 15 years
defined from date of diagnosis to date of death by any cause or loss to follow-up
facilitator/barriers to access to cytoreductive surgery
时间窗: 15 years
topic guide interview questionnaire to be used to elicit factors aiding/preventing access to cytoreductive surgery internationally
progression free survival
时间窗: 15 years
defined from date of diagnosis to date of first recurrence
次要结局
- Resectability rates(at time of surgery)
- Post-operative morbidity(within 30 days from date of surgery)
研究者
Faiza Gaba
Principle Investigator
University of Aberdeen