HYPORT HN-A randomized, non inferiority trial to compare the the average global quality of life score following HYPofractionated radiotherapy versus conventional fractionation in Head and Neck cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- To compare the average global quality of life score following hypofractionated radiotherapy versus conventional fractionation in head and neck cancer
研究概览
简要总结
HYPORT HN SUMMARY
Radiotherapy forms an integral part of Head and Neck cancer treatment in both definitive as well as adjuvant setting. This study explores the use of hypofractionated radiotherapy, delivering 55Gy in 20 fractions over 4 weeks in comparison to the conventional approach which involves 70 Gy over 6 weeks.
Hypofractionated radiotherapy would result in significant benefits in terms of shortening the overall treatment time, countering accelerated hypofraction effects that typically arise after the 4th week. The new approach is also anticipated to offer resource and financial advantages, involving less machine time per patient, and potentially leading to better patient compliance. Previous studies on hypofractionation in Head and Neck cancer have demonstrated good local control and acceptable toxicity levels compared to conventional methods.
The primary objective of this study is to compare the average global quality of life following hypofractionated radiotherapy versus conventional fractionation, with secondary objectives including a comparison of locoregional control at 2 years and assessment of acute and late toxicities.
The study will require 600 eligible patients randomly assigned to either the hypofractionated or conventional arm. For definitive chemoradiation, the control arm will receive 66Gy in 30 fractions over 6 weeks, while the experimental arm will receive 55Gy in 20 fractions over 4 weeks, along with Inj Cisplatin @ 100mg/m2 3 weekly for 2 cycles. In the adjuvant setting control arm will receive 60Gy in 30 fractions over 6 weeks and experimental arm will receive 52.5Gy in 20 fractions over 4 weeks along with Inj Cisplatin @ 100mg /m2 3 weekly for 2 cycles for both arms based on histopathological indications.
Physician reported and patient reported acute toxicities like mucositis, dermatitis and dysphagia, weight loss, requirement and duration of feeding tubes as well as patients reported outcomes in the form of EORTC QLQ C30, HN43 and XeQoLS will be recorded both during and after treatment at regular intervals for 2 years.
The study’s duration is five years, aiming to determine whether the hypofractionated schedule is non-inferior to conventional radiotherapy in terms of safety and disease-related outcomes
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age ≥ 18 years 2)ECOG performance status
- •Patients diagnosed with invasive squamous cell cancer of the head and neck region including lip, oral cavity, nasopharynx, oropharynx, hypopharynx, and larynx 4)Patients with non metastatic cancer, optimally staged with the following: a)Contrast enhanced CT or MRI scan of the neck and CT of the thorax (or whole body FDG PET-CT scan) for cancer lip, oral cavity, oropharynx, hypopharynx, supraglottis, glottis and subglottis b)Magnetic Resonance Imaging of the neck and Whole body PET-CT for cancer of nasopharynx 5)Patients who are being treated with curative intent treatment either with radiotherapy or concurrent chemoradiotherapy, neoadjuvant chemotherapy followed by curative radiotherapy or chemoradiotherapy, or primary surgery followed by adjuvant radiotherapy or chemoradiotherapy. Patients must have a histopathological proof of malignancy, such as biopsy or postoperative histopathology report. Biopsies or surgeries done outside must have been reviewed for pathological confirmation and specimen adequacy at the treating institute.
排除标准
- •Concurrent illness like severe cardiac, renal or hepatic dysfunction and severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety after discussion in MDT 2)Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
结局指标
主要结局
To compare the average global quality of life score following hypofractionated radiotherapy versus conventional fractionation in head and neck cancer
时间窗: 2 years
次要结局
- To compare the locoregional control at 2 years between the hypofractionated and conventional arm.
研究者
Dr Sanjoy Chatterjee
TATA MEDICAL CENTER