An Initial Feasibility Study to Integrate High-precision, Image Guided, Radiotherapy(MRI Based Brachytherapy and CT/MRI Fused Dynamic IMRT Planning) in the Treatment Planning of 10 Patients With Locally Advanced Carcinoma of the Cervix
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Feasibility parameters
研究概览
简要总结
Main cause of mortality in cervix cancer is local relapse in the pelvis. Since distant metastasis is quiet rare, increasing local control in the pelvis can directly translate into improvement in survival. Obstacles in front of this approach is the dose limitation to normal organs located in the pelvis adjacent to the tumor. 3-D MRI based EBRT and Brachytherapy will grant safe delivery of more conformal higher doses of radiation to the tumor and allowing sparing of the normal structures.
详细描述
A total of 10 patients with a diagnosis of locally advanced cervical carcinoma will be enrolled. After diagnosis and written informed consent, patients will undergo investigations prior to treatment planning, including CT imaging as per standard of care. In addition, patients will have an MRI of the pelvis + PET scan + EUA and gold seeds insertion to verify pelvic organs movement and EB-IMRT with daily cone beam CT. Brachytherapy treatment planning will be based on MRI imaging with the applicator in situ.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-chemo-therapy including MRI guided BT. (stage IB2 bulky disease-stage IVa)
- •Staging according to FIGO and TNM guidelines
- •Positive biopsy showing squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix
- •No pelvic nodes > 2cm
- •MRI of pelvis at diagnosis
- •MRI of the retroperitoneal space and abdomen at diagnosis
- •MRI with applicator in place at time of BT
- •Age 18-70 years
- •Patient informed consent
排除标准
- •Pelvic nodes > 2cm
- •Previous pelvic or abdominal radiotherapy
- •Previous total or partial hysterectomy
- •Combination of preoperative radiotherapy with surgery
- •Patients receiving neo-adjuvant chemotherapy
- •Patients receiving BT only
- •Contraindications to MRI
结局指标
主要结局
Feasibility parameters
时间窗: One year
次要结局
- Response rate, acute and late toxicity, local control rate, survival(Five years)
- Dosimetric comparison between 2D and 3D Brachytherapy treatment planning