Stereotactic Body Radiotherapy Boost Versus Simultaneous Integrated Boost to Pelvic Nodes Among Patients Receiving Radical Chemoradiation in Carcinoma Cervix
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Incidence of grade 3 or higher treatment-related adverse events
研究概览
简要总结
Cervical cancer is a significant cause of morbidity and mortality among women worldwide. Radiotherapy, in combination with chemotherapy or as a standalone treatment, is an effective treatment option for cervical cancer. However, traditional radiotherapy has its limitations, such as the potential for damage to surrounding healthy tissues. Stereotactic Body RadioTherapy (SBRT) is a newer radiotherapy technique that delivers high doses of radiation to the tumor with minimal damage to the surrounding tissues. This study aims to evaluate the safety of Stereotactic Body RadioTherapy to involved node in cervical cancer.
详细描述
The goal of this observational study is to compare the safety profile of Stereotactic Body Radiotherapy Boost vs Simultaneous Integrated Boost to pelvic nodes among patients with Stage III-C carcinoma cervix by assessing the acute GI and GU toxicity (>Grade 3 GI/GU toxicity) within 30 days of completion of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with stage IIIC cervical cancer
- •No previous pelvic radiation therapy or surgery
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
排除标准
- •Patients with stage I or stage II or stage IV disease.
- •Patients with prior malignancies or active autoimmune diseases
- •Uncontrolled medical comorbidity
研究组 & 干预措施
Stereotactic Body Radiotherapy (SBRT) boost to involved pelvic lymph nodes (14 Gy in 2 fractions)
The experimental arm Stereotactic Body Radiotherapy (SBRT) boost regimen will consist of two fractions of 700 cGy each total of 14Gy in 2 fractions, delivered at 1st and 2nd week of the treatment.In the proposed protocol, the pelvic field dose will be delivered as 45 Gy in 25 fractions, while the nodal boost will be delivered as SBRT 14 Gy in 2 fractions, typically at the first and second weeks of treatment, subject to plan evaluation and organ-at-risk constraints. This sequencing is consistent with the concept of combining broad pelvic coverage with ablative focal escalation.
Patients will be immobilized supine with an abdominopelvic thermoplastic shell, and simulation will be performed using contrast-enhanced planning CT with MRI and PET-CT fusion where available. Bladder and bowel preparation will be standardized before simulation and treatment to improve reproducibility and reduce interfraction variation.
干预措施: Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph Nodes (Radiation)
Conventional nodal boost by Simultaneous Integrated Boost (SIB)to involved pelvic lymph nodes)
Patients in the standard arm will receive conventional radical chemoradiation for locally advanced carcinoma cervix with pelvic external beam radiotherapy and concurrent weekly cisplatin, followed by brachytherapy. Pelvic radiotherapy will be delivered to a dose of 45 Gy in 25 fractions over 5 weeks, using IMRT/VMAT or fixed-field technique, with standard contouring of elective pelvic target volumes and gross disease. The nodal boost will be delivered as a conventional Simultaneous Integrated Boost (SIB) to the involved pelvic node(s) during the course of external beam radiotherapy. A total dose of 55 Gy or 57.5 Gy in 25 fractions, delivered in a simultaneous integrated manner according to nodal size, location, and institutional planning constraints. Treatment will be planned with appropriate image guidance, and organs at risk will be respected according to predefined dose constraints. Toxicity will be monitored during treatment and follow-up, and graded using CTCAE version 5.0.
干预措施: Standard Arm: Simultaneous Integrated Boost to involved pelvic node (Radiation)
结局指标
主要结局
Incidence of grade 3 or higher treatment-related adverse events
时间窗: 30 days
The primary outcome measure is the incidence of grade 3 or higher treatment-related adverse events, specifically acute gastrointestinal and genitourinary toxicity, assessed within 30 days of completion of treatment using CTCAE version 5.0.
次要结局
- Grade 3 or higher acute gastrointestinal and genitourinary toxicity(6 months)
- Dosimetric comparison(6 months)
- Local control(6 months)
研究者
Karun Kamboj
Assistant Professor
All India Institute of Medical Sciences