NCT02681432Unknown3 期
Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel for the Treatment of Patients With Recurrent or Primary Advanced Ovarian Cancer : A Randomised Phase 3 Study
PEDRO VILLAREJO CAMPOS1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.
详细描述
Randomized clinical trial performed in woman with epithelial primary ovarian cancer (stage FIGO II, III and IV) or tumor recurrence. A cytoreductive surgery will be perform in all of the patients include in the trial, and it will be assign at randomization:
- HIPEC-arm: cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with paclitaxel (175 mg / m2) for 60 minutes at a temperature of 42-43º degrees; followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.
- No HIPEC-arm: Cytoreductive surgery followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histologically confirmed epithelial ovarian cancer (stage II / III / IV disease of FIGO) or tumor recurrences (the women of childbearing age need to have a negative pregnancy test)
- •Complete cytoreduction: Index CC0/CC1 cytoreduction (residual tumor size after surgery, no visible (CC0) or less than 0.25 cm (CC1))
- •No extra-abdominal tumor disease
- •Absence of heart failure. Adequate renal and hepatic functions
- •Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%
排除标准
- •Patients with unresectable tumor or incomplete cytoreduction.
- •Contraindications for treatment with paclitaxel: patients with severe hypersensitivity to paclitaxel or any of the excipients,pregnancy or lactation and patients with baseline neutrophil count <1.500/mm3 (<1.000/mm3 for patients with Kaposi sarcoma). Paclitaxel is also contraindicated in patients who have concurrent and severe infections.
- •Extra-abdominal metastases or unresectable liver metastases
- •Presence of other malignant tumor disease.
- •Multisegmental complete bowel obstruction.
- •Patients with severe medical problems that will preclude compliance with the study or with an unacceptable risk
- •Patients who refuse treatment or consent to participate in study
研究组 & 干预措施
HIPEC
Experimental
Primary ovarian cancer FIGO stage II, III or IV or recurrent
干预措施: HIPEC (Drug)
No HIPEC
Active Comparator
Primary ovarian cancer FIGO stage II, III or IV or recurrent
干预措施: No HIPEC (Procedure)
结局指标
主要结局
Overall survival
时间窗: every 6 months till 36 months
From the date of surgery to the date of death or to the end of study (follow up every 6 months till 3 years)
次要结局
- Progression free survival(follow up every 6 months till 18 months)
研究者
PEDRO VILLAREJO CAMPOS
MD, PhD.Associate Professor of Surgery. University of Castilla-La Mancha
Hospital General de Ciudad Real
研究点 (1)
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