Stereotactic Body Radiotherapy (SBRT) boost versus Simultaneous Integrated Boost (SIB) to pelvic nodes among patients receiving radical chemoradiation in Carcinoma Cervix: A Prospective, pilot Study comparing safety profiles.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- The primary objective is to compare the safety profile of SBRT boost vs SIB to pelvic nodes among
研究概览
简要总结
I am writing to request the registration of our clinical trial, "Stereotactic Body Radiotherapy (SBRT) Boost versus Simultaneous Integrated Boost (SIB) to Pelvic Nodes among Patients Receiving Radical Chemoradiation in Carcinoma Cervix: A Prospective, Pilot Study Comparing Safety Profiles," under CTRI.
I request your assistance in facilitating the registration process under the CTRI for this study to contribute valuable insights into optimising radiotherapy approaches in carcinoma cervix management.
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 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients aged 18 years or older with locally advanced cervical cancer suitable for primary treatment with chemoradiotherapy.
- •Pathologically confirmed carcinoma cervix squamous,adenocarcinoma,adeno-squamous carcinoma histology.
- •Patients with stage IIIC disease, who have not undergone previous pelvic radiation therapy or surgery and have an Eastern Cooperative Oncology Group performance status of 0-
- •Patients diagnosed with cervical cancer with pelvic nodal burden less than 3cm or 30cc up to 4 lymph nodes who are eligible for chemo-radiotherapy.
- •Signed informed consent.
- •Adequate end organ function hepatic, renal, cardiac reserve.
排除标准
- •Patients with stage I or stage II or stage IV disease Patients with prior malignancies or active autoimmune diseases will be excluded from the study.
- •Other histology melanoma, small cell, basal cell carcinoma Previous pelvic radiotherapy, hysterectomy, any form of oncological treatment.
- •Contraindications to CEMRI, brachytherapy Age less than 18 years.
- •Uncontrolled medical comorbidity.
结局指标
主要结局
The primary objective is to compare the safety profile of SBRT boost vs SIB to pelvic nodes among
时间窗: The toxicity will be assessed at the following time points: baseline, 4 weeks, 3 months, and 6 months post-treatment completion.
patients with Stage III-C carcinoma cervix by assessing the acute GI and GU toxicity (Grade 3
时间窗: The toxicity will be assessed at the following time points: baseline, 4 weeks, 3 months, and 6 months post-treatment completion.
GI/GU toxicity) within 30 days of completion of treatment.
时间窗: The toxicity will be assessed at the following time points: baseline, 4 weeks, 3 months, and 6 months post-treatment completion.
次要结局
- To compare the dosimetry of organs at risk between the two study arms.(ï‚· To evaluate the efficacy of SBRT in terms of local control using radiological imaging by)
研究者
DR KARUN KAMBOJ
AIIMS New Delhi