Phase II Study Evaluating the Role of Tomotherapy- Based Intensity Modulated Radiotherapy and Brachytherapy in Postsurgery Recurrent Carcinoma Cervix
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- To evaluate the utility of intensity-modulated radiotherapy (IMRT) in delivering dose escalated radiotherapy in postoperative recurrent cases of carcinoma cervix, in terms of local control
研究概览
简要总结
Radiotherapy is the most appropriate treatment for postoperative recurrent carcinoma cervix. However it is technically difficult to deliver adequate doses of RT due to presence of small intestines in the radiation area; thus disease control rates are poor and complication rates are high with conventional radiotherapy. Use of IMRT and brachytherapy for these cases allows for increasing dose to the tumor while sparing normal structures. It is expected that the use of a combination of IMRT & brachytherapy will achieve higher disease control rates and decrease the complication rates.
详细描述
SPECIFIC OBJECTIVES:
- To evaluate the efficacy of combination of intensity-modulated radiotherapy (IMRT) and brachytherapy in delivering dose escalated radiotherapy in postoperative residual / recurrent cases of carcinoma cervix, in terms of local control proportion and progression free survival (PFS)
- To study the late and acute toxicities associated with this treatment.
- Dosimetric comparison of Tomotherapy and conventional IMRT
DESIGN: Prospective, phase II study.
STUDY POPULATION: All patients of age < 65 years diagnosed with postsurgery recurrent squamous cell carcinoma cervix without previous history of radiotherapy.
STUDY SIZE: 90 patients
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
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •. Only histologically proven postoperative recurrence of squamous carcinoma of cervix following hysterectomy >3 months without adjuvant treatment
- •Patients below 65 years of age and with KPS >70%.
- •Patients with disease confined to the pelvis, based on CT/MRI/PET Scan
- •Normal ECG and cardiovascular system
- •Normal hematological parameters
- •Normal renal and liver function tests
排除标准
- •Previous chemotherapy or radiotherapy to the pelvis
- •Pelvic LN >3cm in size
- •Presence of disease outside the pelvis (Paraortic nodes, distant metastasis)
- •Bilateral hydronephrosis
- •Co-morbid conditions like uncontrolled Diabetes Mellitus or medical renal disease
- •Medical or Psychological condition that would preclude treatment
- •Patient unreliable for treatment and follow-up.
结局指标
主要结局
To evaluate the utility of intensity-modulated radiotherapy (IMRT) in delivering dose escalated radiotherapy in postoperative recurrent cases of carcinoma cervix, in terms of local control
时间窗: 3 Years
Progression free survival of all patients
次要结局
- To study the late toxicities associated with this treatment(3 Years)