CTRI/2023/02/049783招募中不适用
Comparison of two palliative hypofractionated Radiotherapy schedules in patients of advanced Head and Neck Squamous cell Carcinoma - a single institutional prospective randomized study.
未提供1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月22日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- QUAD SHOT IS AN EFFECTIVE PALLIATIVE REGIMEN FOR ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA.
研究概览
简要总结
Aggressive radical treatment may not be suitable for many patients of advanced head and neck cancers. Palliative Hypofractionated radiotherapy plays a pivot role for symptoms palliation. Here we compare between two palliative hypofractionated radiotherapy schedules of standard or conventional and Quad Shot regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 to 80 years -Histopathologically diagnosed as squamous cell carcinoma -Cancer of head and neck involving the following sub-sites:- o Oral cavity o Oropharynx o Hypo-pharynx o Larynx -De-novo or recurrent / refractory cases -Clinically stage group III to IVC (AJCC 8th Edition) -ECOG PS 0 to 3 -Deemed unsuitable for surgery / inoperable in a multidisciplinary tumour board -Calculated life expectancy > 90 days -Baseline Haemoglobin>9 gm/dl, ANC > 1500/µl, platelets > 1,00,000/µl -Creatinine Clearance >30 ml/min -Written informed consent.
排除标准
- •Histopathology other than squamous cell carcinoma -Pregnancy and lactation -Uncontrolled severe comorbidities -Severe dyselectrolytaemia -Sub-sites other than Oral cavity, Oropharynx, Hypo-pharynx and Larynx -Major psychiatric illness making the patient incapable of following medical advice -Prior head and neck radiotherapy within the last 6 months -Prior head and neck surgery within the last 3 months -Concomitant or prior chemotherapy / targeted therapy / immunotherapy within the last 2 weeks -Inability to receive palliative radiotherapy due to patient’s clinical condition, positional or immobilization issues or other reasons -Unwillingness to undergo palliative radiotherapy -Refusal to provide informed consent.
结局指标
主要结局
QUAD SHOT IS AN EFFECTIVE PALLIATIVE REGIMEN FOR ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA.
时间窗: AT BASELINE, DAY 3, DAY 7, DAY 28, SUBSEQUENTLY IN EVERY MONTHS.
次要结局
未报告次要终点
研究者
研究点 (1)
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