Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Evaluation and comparison of early surgical complications of primary surgery and Interval debulking surgery.
研究概览
简要总结
Patients with advanced ovarian cancer (FIGO stage III C) and highly disseminated tumor will be randomized into two arms: primary debulking surgery followed by adjuvant chemotherapy vs. neoadjuvant chemotherapy followed by interval debulking surgery (IDS). The primary end point is the evaluation and comparison of the surgical complications of primary surgery and IDS and the evaluation of the progression free survival (PFS)
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected advanced ovarian cancer (FIGO stage IIIC)
- •PIV ≥ 8, PIV ≤ 12
- •Estimated life expectancy of at least 4 weeks.
- •Appropriate respiratory, hepatic, cardiological, bone marrow and renal functions (Creatinine Clearance > 60 mL/min according to Cockcroft formula)
- •Patient capable of consent.
排除标准
- •Pregnancy or breastfeeding.
- •Non-appropriate respiratory, hepatic, cardiological, bone marrow and renal functions
- •Large size mass reaching the xiphoid, occupying all the abdominal cavity and/or infiltrating the abdominal wall.
- •Mesenteric retraction
研究组 & 干预措施
Primary debulking surgery
All patients with suspicion of advanced ovarian carcinoma (FIGO stage IIIC) will undergo to a diagnostic laparoscopy in order to obtain a laparoscopic score (PIV) based on seven parameters: omental cake, peritoneal and diaphragmatic extensive carcinosis, mesenteric retraction, bowel and stomach infiltration, spleen and/or liver superficial metastasis, as previously published (Fagotti et al, American Journal of Obstetrics and Gynecology, 2008) Patients with PIV ≥ 8 and ≤ 12 randomized in this group will be submitted to an attempt of primary debulking surgery in order to obtain RT < 1 cm, followed by adjuvant chemotherapy.
干预措施: Primary Debulking Surgery + Adjuvant Chemotherapy (Procedure)
Interval debulking surgery
All patients with suspicion of advanced ovarian carcinoma (FIGO stage IIIC) will undergo to a diagnostic laparoscopy in order to obtain a laparoscopic score (PIV) based on seven parameters: omental cake, peritoneal and diaphragmatic extensive carcinosis, mesenteric retraction, bowel and stomach infiltration, spleen and/or liver superficial metastasis, as previously published (Fagotti et al, American Journal of Obstetrics and Gynecology, 2008) Patients with PIV ≥ 8 and ≤ 12 randomized in this group will be submitted only to diagnostic laparoscopy followed by neoadjuvant chemotherapy and subsequent Interval Debulking Surgery, followed by further cycles of chemotherapy.
干预措施: Neoadjuvant chemotherapy + Interval Debulking Surgery (Drug)
结局指标
主要结局
Evaluation and comparison of early surgical complications of primary surgery and Interval debulking surgery.
时间窗: thirty days
Early surgical complications: * Blood transfusion * Re-laparotomy * suture dehiscence of laparotomy. * Venous thrombosis * Haemorrhage * Death in the post-operative period * Digestive fistula * Urinary fistula * Lymphocyst * Fever * Infection * Pleural effusion * Pulmonary embolism * Pneumothorax * Pneumonia
Evaluation and comparison of late surgical complications of primary surgery and Interval debulking surgery
时间窗: six months
Late surgical complication: * Death for every reason. * Suture dehiscence of laparotomy with opening of the abdominal muscles * Fever due to lymphocystis infection
Evaluation of the progression free survival (PFS)
时间窗: Thirty-six months
Time from randomization until recurrence of tumor or death from any cause.
次要结局
- Overall Survival(Thirty-six months)
- Evaluation of Quality of life(12 months)
研究者
Prof. Giovanni Scambia
Professor
Catholic University of the Sacred Heart