A Comparative Study Between Two Thoracic Radiotherapy Schedules for Palliation of Symptoms, Radiological Responses and Acute Toxicities in Stage IV Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare between two radiotherapy regimens p 20 Gy/5# in 5 consecutive days and 17 Gy/2# over a week apart and fine the more effective one in terms of:
研究概览
简要总结
Despite numerous research articles published over the years to determine the most effective radiotherapy regimen for Stage IV non-small cell lung cancer (NSCLC), particularly for acute palliative care, a definitive consensus remains elusive. Both extended and short fraction regimens have been thoroughly investigated, yet the choice of regimen often hinges on institutional protocols, the preferences of the treating physician, and, most importantly, the general condition of the patient. Various countries and treatment centres may opt for different regimens based on resource availability, patient volume, and clinical experience. It has been observed that while long-duration regimens may offer better overall survival for patients in good condition, hypo-fractionated regimens provide comparable efficacy in symptom control with fewer treatment sessions. However, longer regimens may increase the risk of toxicity and adverse effects on critical structures. This ongoing uncertainty underscores the need for further research tailored to specific clinical settings.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically or Cytologically proven Non-Small Cell Lung Cancer
- •Stage IV Lung Cancer, according to AJCC Staging 9th version
- •Age more than 18 years and less than 70 years
- •ECOG Grade 0-3
- •Patients willing to take part in the study with an informed written consent.
排除标准
- •Small Cell Lung Cancer
- •Patients with collagen vascular disease or any other systemic comorbidities or severe uncontrolled infection, which may alter treatment outcome.
- •Pregnant or Nursing Women
- •Patients who had deranged blood parameters, impaired liver function, renal function and bone marrow suppression.
- •Patients refusing to take part in the study.
结局指标
主要结局
To compare between two radiotherapy regimens p 20 Gy/5# in 5 consecutive days and 17 Gy/2# over a week apart and fine the more effective one in terms of:
时间窗: 18 months
1. Symptom relief
时间窗: 18 months
2. To check acute toxicities using RTOG scale, and manage patients, if necessary
时间窗: 18 months
3. To evaluate the variation in symptomatic relief associated with different presenting symptoms when administering two distinct radiotherapy regimens, using LCSS scale/RTOG 4 point scale
时间窗: 18 months
次要结局
未报告次要终点
研究者
Dr Sharad Sah
IPGMER and SSKM Hospital, Kolkata