Tomotherapy in Postsurgery Recurrent Carcinoma Cervix
Phase II Study Evaluating the Role of Tomotherapy- Based Intensity Modulated Radiotherapy and Brachytherapy in Postsurgery Recurrent Carcinoma Cervix
研究概览
详细说明
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
METHODOLOGY: Ninety cases of cervical cancer with postsurgery recurrence limited to the pelvis will be screened and taken for study if eligible after taking the informed consent.
Patients will receive external radiation therapy using IMRT to pelvis with additional dose of localized radiotherapy boost with brachytherapy to the vault with weekly concurrent chemotherapy.
The local recurrence rate and 5 year disease free survival rate of all the patients will be studied.
PROJECT PERIOD:
Total project period : 5 years Recruitment, Data collection : 4 years Complete analysis of data : 1 year
STUDY SITE: Tata memorial centre
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
Maharashtra
-
Mumbai、Maharashtra、印度、400012
- 招聘中
- Tata Memorial Centre
-
接触：
- Reena Engineer, MD
- 电话号码：+912224177165
- 邮箱：reena_engineer@rediffmail.com
-
接触：
- ShyamKishore Shrivastava, MD
- 电话号码：+912224177163
- 邮箱：shrivastavask@tmc.gov.in
-
首席研究员：
- Reena Engineer, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
. 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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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
大体时间：3 Years
|
Progression free survival of all patients
|
3 Years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To study the late toxicities associated with this treatment
大体时间：3 Years
|
Side effects of radiotherapy and chemotherapy will be recorded at baseline, during treatment, at 6 and 12 months and annually thereafter according to the RTOG scales
|
3 Years
|
合作者和调查者
调查人员
- 首席研究员：Reena Engineer, MD、Tata Memorial Centre
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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