Randomized Trial to Evaluate Accelerated Radiotherapy in the Management of Locally Advanced Carcinoma of Nasopharynx Using Rapid Arc Image Guided Radiotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- To compare overall response rates between the two study group
研究概览
简要总结
The present study is designed as a two arm randomized trial to evaluate the impact of accelerated radiotherapy delivered by image guided radiotherapy with rapid arc technique in carcinoma nasopharynx. The study will evaluate a pure acceleration schedule of 6 fractions per week with concurrent chemotherapy and without any radiotherapy dose escalation.The control arm will receive standard chemoradiotherapy using image guided radiotherapy with rapid arc technique.
详细描述
The study is designed as a two arm prospective randomized controlled trial which will be carried out in the Department of Radiotherapy and Otolaryngology at PGIMER, Chandigarh.
Inclusion criteria
- Histopathologically proven non keratinizing nasopharangeal cancers.
- Karnofsky performance status more than 70
- Stage T3-4, N0-3 patients (as per AJCC 8th edition).
- Patients willing for informed consent and regular follow up
Exclusion Criteria
- Keratinizing squamous cell carcinoma
- Age >70 years
- Patients who have received previous chemoradiotherapy.
- Patients with uncontrolled co- morbid conditions like hypertension , diabetes or any renal impairment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically proven non keratinizing nasopharangeal cancers.
- •Karnofsky performance status more than 70
- •Stage T3-4, N0-3 patients (as per AJCC 8th edition).
- •Patients willing for informed consent and regular follow up
排除标准
- •Keratinizing squamous cell carcinoma
- •Age >70 years
- •Patients who have received previous chemoradiotherapy.
- •Patients with uncontrolled co- morbid conditions like hypertension , diabetes or any renal impairment
结局指标
主要结局
To compare overall response rates between the two study group
时间窗: At 1 year follow up
Overall survival will be compared between the study and control group at end of study
To compare acute treatment related toxicity between the two study groups
时间窗: Within 90 days of completion of treatment
Patients under study will be monitored for acute toxicity using CTCAEv3
次要结局
未报告次要终点
研究者
AMIT BAHL
ADDITIONAL PROFESSOR
Post Graduate Institute of Medical Education and Research, Chandigarh