A randomized controlled trial of neoadjuvant chemotherapy with interval cytoreduction vs primary cytoreduction in advanced (stage IIIc/IV) epithelial ovarian cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 2. To compare operating time, blood loss, organ resections needed, perioperative complications and length of postoperative stay in the two groups.
研究概览
简要总结
Ovarian cancer is the second most common gynceological malignancy world wide. In India it is the third most common cancer among women. Most of the women present at an advanced stage leading to higher morbidity and moratality. The current standard treatment to advanced epitehlial ovarian cancer is primary surgery followed by 6 cycles of platinum based adjuvant chemotherapy. There is no level 1 evidence to this approach. An alternate has been recently proposed and tested by some authors. This included initial 3 cycles of platinum based chemotherapy followed by surgery and later additional 3 cycles of chemotherapy. In this study we are comparing these two approaches in a randomized manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Previously untreated patients with cytologically/histologically proven ovarian cancer showing peritoneal deposits outside the pelvis of >2cms either clinically/ radiologically 2.Patients with cytological/histologically proven ovarian cancer with regional lymph node metastasis 3.Patients with malignant pleural effusion confirmed to be of ovarian origin,.
排除标准
- •1.Patients with early stage ovarian cancer and those with peritoneal deposits <2 cms.
- •2.Patients with distant metastasis except mentioned above.
- •3.Nonepithelial tumors of ovary such as germ cell tumor, sexcord stromal tumor etc.
- •4.Patients who have been previously treated or started treatment outside the institute or recurrent lesions will be excluded.
- •5.Patients with poor performance status or medical contraindications for chemotherapy and/or surgery will be excluded.
结局指标
主要结局
2. To compare operating time, blood loss, organ resections needed, perioperative complications and length of postoperative stay in the two groups.
时间窗: February 2015
To compare primary debulking surgery followed by chemotherapy and neoadjuvant chemotherapy followed by interval debulking surgery and additional chemotherapy in women with stage IIIc/IV epithelial ovarian carcinoma.
时间窗: February 2015
次要结局
- To compare the rates of optimal cytoreduction in both the groups(4. To compare loco-regional recurrence rates and disease free survival in the two groups.)