A Prospective Observational Study on CT Image Based Adaptive Brachytherapy in Locally Advanced Cervical Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the feasibility of delineating HR-CTV on CT image following IBS-GEC ESTRO-ABS recommendations & Pre- & Post-EBRT MRI images.
研究概览
简要总结
Aim of this observational study is to evaluate feasibility of target delineation on CT image for image guided brachytherapy in cervical cancer along with dosimetric analysis & comparison between volume-based dose prescription & point A based dose prescription.The proposed prospective study will be carried out at the Department of Radiation Oncology, Chittaranjan National Cancer Institute,Kolkata. Patients accrued in the study as per inclusion and exclusion criteria, will receive brachytherapy after completion of external-beam radiotherapy. Periodic follow-up of patients will be done to assess the treatment response & toxicities with special attention to GI and GU toxicity.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patients of cervical cancer sent from multidisciplinary tumor board after being proved on histopathology (squamous cell or adenocarcinoma) with FIGO stage IB2 to III 2.Eastern Cooperative Oncology Group performance status upto 2 3.Hemoglobin >10 gm%, Total leukocyte count> 4000 cells/cmm, Platelet count> 1,00,000 cells/cmm (initially or after correction by blood transfusion).
- •4.Liver function test- AST< 2×Upper normal limit, bilirubin <2×upper normal limit Kidney function test- Serum creatinine<1.5 mg/dL and calculated creatinine clearance using the Cockroft-Gault formula >50 ml/min 5.Patient with no history or current clinical evidence of any hematological or bleeding disorders 6.No history of drug use which results in hematological toxicity 7.HBsAg, Anti-HCV, HIV-I & -II Antibody non-reactive patients.
排除标准
- 未提供
结局指标
主要结局
To assess the feasibility of delineating HR-CTV on CT image following IBS-GEC ESTRO-ABS recommendations & Pre- & Post-EBRT MRI images.
时间窗: At baseline
Computation of target coverage along with the doses received at Point A.
时间窗: At baseline
To compare the doses received by bladder, rectum & bowel as per volume-based dose prescription and Point A-based dose prescription.
时间窗: At baseline
次要结局
- To assess the treatment response & toxicity with special attention to Gastrointestinal (GI) & Genitourinary(GU) toxicity.