NCT02993653Unknown2 期
Definitive Treatment Protocol for High-dose Intensity-modulated Radiotherapy (IMRT) With Intracavitary Radiotherapy in Locally Advanced Cervical Cancer: A Phase II Trial
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial
详细描述
Radiotherapy
- intensity-modulated radiotherapy of whole pelvis: 60 Gy in 30 fx Re-simulation with pelvic Magnetic resonance imaging at 46 Gy in 23 fx and intensity-modulated radiotherapy on the gross cervical and nodal tumor (initially Positron emission tomography-positive), 14 Gy in 7 fx
- intensity-modulated radiotherapy boost of gross cervical tumor or Intra-cavitary radiotherapy (ICR)
- Re-staging pelvic Magnetic resonance imaging , if complete response occurs Intra-cavitary radiotherapy to A point, 25 Gy in 5 fx for 2 weeks
- Re-staging pelvic Magnetic resonance imaging I, partial response or stable disease occurs intensity-modulated radiotherapy boost , 10 Gy in 4 fx to the gross cervical tumor for 1 week
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •FIGO II-IVA Patients with untreated and histologically confirmed carcinoma of the uterine cervix
- •Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1
- •Patients with adequate bone marrow function: Absolute nutrophil count (ANC) greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl at the beginning
- •Patients with adequate renal function: creatinine equal to or less than 2.0 mg/mL
- •Patients who have signed an approved informed consent and authorization
排除标准
- •Patients with recurrent cervical cancer
- •Patients who have diagnosis of other malignance tumors except papillary or follicular thyroid cancer or skin cancer
- •Patients with metastatic lymphadenopathies other than pelvis (e.g. inguinal, paraaortic, supraclavicular, or mediastinal node)
- •Patients with distant organ metastasis
结局指标
主要结局
Progression-free survival
时间窗: 30 months
Progression means locoregional recurrence, distant metastasis, and local tumor pregression
次要结局
- Overall survival(30 months)
- Treatment-related adverse events are assessed by CTCAE v4.0.(acute within 3 months and chronic after 3 months after radiotherapy)
研究者
Jong Hoon Lee
Professor
Seoul St. Mary's Hospital
研究点 (1)
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