Clinical outcomes of cervical cancer with a short intra-cavitary brachytherapy schedule involving 5 sessions of 6Gy each.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Tumor Response in terms of partial or complete response. It will be assessed by clinical or radiological imaging.
研究概览
简要总结
The project title is Clinical outcomes of Cervical Cancer with a short intra-cavitary brachytherapy schedule involving 5 sessions of 6Gy each.
Cervical cancer, a preventable and treatable disease, is still a leading cause of mortality among women in developing countries. As per GLOBOCAN 2020 statistics, 1,23,907 new cases were diagnosed and 77,348 lost their lives in India alone. In a locally advanced cervical cancer combined chemoradiation and brachytherapy is the standard of care treatment. Brachytherapy involves the application of a radioactive source near the tumor. It takes advantage of the inverse-square law, whereby radiation dose is inversely proportional to the square of the distance from the source. In practical terms, this allows for a very high dose to the tumor with relative sparing of the surrounding normal structures. Two applications multi fractionated Brachytherapy augments early completion of treatment which has been explored in cervical cancer, with no increase in acute or late toxicities with improved clinical outcomes in terms of local control, disease free survival, and overall survival by improving compliance and reducing overall treatment time. Individual fraction size be < 7.5Gy and the range of fractions should be 4 to 8; however, many fractionation schedules, varying from institution to institution are in use. We plan to deliver 5 sessions of 6Gy brachytherapy in two settings with a one-week gap and expect an increase in patient compliance with a reduction in overall treatment time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- Female
入选标准
- •Biopsy-proven newly diagnosed carcinoma cervix Patients fit for chemotherapy Age less than 65 years without comorbid conditions FIGO Stage IB, IIA, IIB, IIIB without lower one-third involvement ECOG 0-2 No major life-threatening complications.
排除标准
- •More than 65 years ECOG 3 or more Prior pelvic radiotherapy Uncontrolled Diabetes and hypertension Patients with a prior history of DVT/Pulmonary embolism Lower one-third involvement of any stage.
结局指标
主要结局
Tumor Response in terms of partial or complete response. It will be assessed by clinical or radiological imaging.
时间窗: it will be assessed over 2 monthly follow up to 1 year. | The baseline will be the initial tumor size before the application.
次要结局
- Acute toxicities like diarrhea, dermatitis, anemia, neutropenia, etc.(Assessed weekly during radiation therapy)
- Late toxicities which include cystitis & proctitis etc(6 months up to 1 year)
研究者
Muhammed Basil Y P
Jawaharlal Institute of Post Graduate Medical Education and Research,JIPMER
