Pelvic versus extended field radiotherapy in locally advanced pelvic node positive cervical cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assess the quality of life in both RT arms after chemoradiation followed by brachytherapy.
研究概览
简要总结
There is a paucity of prospective studies comparing pelvic versus extended field radiation with concurrent chemotherapy (CCT).
The current study is based on the hypothesis that addition of prophylactic Extended Field Radiotherapy is expected to result in better Para- aortic lymph nodal control and hence, an improved distant control. Further, the use of image guided external radiotherapy techniques will allow for dose escalation to the involved pelvic nodes without increasing morbidity. The goal of this study is to compare EFRT with standard pelvic radiotherapy in terms of QOL, acute normal tissue response and early treatment outcomes in patients of cervical cancer with pelvic lymph nodal disease at the time of diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •ECOG score of 0-
- •Patients with pelvic node metastasis (FIGO 2018 Stage IIIc1).
- •3.Pelvic lymph node metastasis (pathologic) diagnosed on CT scan/ MRI with highest pelvic node level 1 cm below the aortic bifurcation.
- •Previously untreated, biopsy proven cervical squamous cell carcinoma/ adeno-squamous cell carcinoma.
- •Suitable for concurrent chemoradiation with platinum based chemotherapy
- •Patient’s willingness to give informed consent for the treatment and regular follow up after completion of the treatment throughout the follow up period.
排除标准
- •Patients with para-aortic nodal disease (IIIC2), Stage IVA or Stage IVB disease .
- •Patients with horseshoe kidney.
- •Synchronous malignancy or previous history of malignancy.
- •Presence of uncontrolled or severe comorbidities.
- •Deranged renal function tests.
- •History of pelvic surgery.
结局指标
主要结局
Assess the quality of life in both RT arms after chemoradiation followed by brachytherapy.
时间窗: Baseline and 3months after completion of treatment.
次要结局
- 1.Acute normal tissue response between the two arms.(1.Acute normal tissue reaction during the treatment and at 3 months after completion of treatment.)
- Early treatment outcome after completion of RT in both arms.(At 3 months after completion of treatment.)
研究者
Swapnil
Post Graduate Institute of Medical Education and Research