Comparative evaluation of Accelerated Radiotherapy with concurrent Chemotherapy versus conventional fractionation chemoradiotherapy in head and neck cancers using Volumetric Modulated Arc Therapy: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare the locoregional control rates in both the arms.
研究概览
简要总结
Study Overview and Objectives: This study compares accelerated radiotherapy with concurrent chemotherapy against conventional fractionation chemoradiotherapy in locally advanced head and neck cancers using Volumetric Modulated Arc Therapy (VMAT). The primary objective is to compare locoregional control rates, with secondary objectives including disease-free survival, toxicity assessment, and treatment compliance.
Study Design and Population: An open-label, prospective, single-centre randomized control trial conducted at AIIMS Bathinda over 6 months
Sample Size and Randomization: Sample size was calculated as 35 patients per arm based on locoregional control rates from DAHANCA 6 and 7 trials. Two treatment arms: Arm A receives 70 Gy in 35 fractions over 6 weeks with Cisplatin 40 mg/m2; Arm B receives 70 Gy in 35 fractions over 7 weeks with the same chemotherapy regimen.
Study Flow and Follow-up: Patients provide informed consent, undergo eligibility screening, and are followed up at 1, 2, 4, and 6 months post-treatment for response evaluation at primary and regional sites, toxicity profiling, and imaging (PET CT/CECT) using RECIST criteria.
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
- •Biopsy proven squamous cell carcinoma of head and neck.
- •Patients who did not receive any prior management for the malignancy like surgery, radiotherapy or chemotherapy.
- •Patients having malignancy in nasopharynx, oropharynx, hypopharynx and larynx amongst the subsites of head and neck.
- •Patients with malignancy of aforementioned sites of Stage II, III, IV A and IV B Patients’ performance status should be less than or equal to 2 according to ECOG.
- •Patients who are willing to provide written informed consent.
排除标准
- •Patients less than 18yrs of age or more than equal to 70 years of age Patients having malignancy in lips, oral cavity, nasal cavities and paranasal sinuses.
- •Patients who received prior management in the form of surgery, radiation or chemotherapy ECOG score more than 2 Patients with metastatic disease Patients with deranged renal function Patients not willing to give written consent.
结局指标
主要结局
To compare the locoregional control rates in both the arms.
时间窗: To compare the locoregional control rates in both the arms at the end of 6 months
次要结局
- 1. To compare the disease-free survival rates in each arm of the study.
研究者
Sneha Bose
All India Instituteof Medical Sciences, Bathinda