Consolidation Intensity-Modulated Whole Abdominal Radiotherapy for High-Risk Patients With Ovarian Cancer Stage FIGO III
试验速览
- 阶段
- 2 期
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- compatibility of the treatment
研究概览
简要总结
The primary objective of this phase-II study is to assess the toxicity of consolidation intensity-modulated whole-abdominal radiotherapy using tomotherapy in patients with advanced optimally debulked stage International Federation of Gynecology and Obstetrics (FIGO) III ovarian cancer with a complete remission after adjuvant chemotherapy.
36 patients will be treated to a total dose of 30 Gy in 1.5 Gy fractions. The planning target-volume includes the entire peritoneal cavity and the pelvic and para-aortal node regions. Intensity-modulated whole-abdominal radiotherapy allows an effective sparing of liver, kidneys and bone-marrow (vertebral bodies and pelvic bones).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •histologically confirmed ovarian cancer or tube cancer or primary peritoneal carcinoma stage FIGO III
- •primary optimal debulking surgery
- •postoperative gross residual tumor ≤ 1cm ( R0, R1 oder R2 < 1cm situation)
- •adjuvant chemotherapy with platin and taxane
- •complete remission after chemotherapy
- •Karnofsky performance score > 60
- •patients >18 years of age
- •written informed consent
排除标准
- •stage FIGO I or II
- •stage III with postoperative gross residual tumor > 1cm
- •stage FIGO IV
- •recurrence situation
- •delayed wound healing post laparotomy
- •leucopenia <2000/ml before radiotherapy
- •thrombocytopenia <75000/ml before radiotherapy
- •clinically active renal, hepatic, cardiac, metabolic, respiratory, coagulation or hematopoietic disease
- •status post pelvic or abdominal radiotherapy
- •status post other cancer disease in the past 5 years (cervical cancer in situ, basal cell carcinoma, squamous cell carcinoma of the skin are excluded)
- •participation in another clinical trial
结局指标
主要结局
compatibility of the treatment
时间窗: Beginning of radiotherapy till 6 weeks after its completion
Therapy compatibility defined as non-occurrence of life-threatening grade 4 (CTCAE v3.0) acute toxicity
次要结局
- Rate of incomplete radiotherapy(4 weeks)
- Overall survival(3 years)
- Rate of delayed radiotherapy(4 weeks)
- Acute toxicity(From the beginning of radiotherapy till 6 weeks after its completion)
- Late Toxicity(6 weeks -3 years after the completion of radiotherapy)
- Disease-free survival(3 years after the completion of radiotherapy)
- Quality of life(3 years)