A Randomised Non Inferiority Trial to Compare the Average Global Quality of Life Score Following Hypofractionated Radiotherapy Versus Conventional Fractionation in Head and Neck Cancers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 2
- 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
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
详细描述
Head and neck cancers comprise of cancers of arising from the epithelial lining of the lip, oral cavity, pharynx and larynx. The overall incidence of Head and Neck cancers continues to increase, despite decrease in the incidence of smoking suggestive of potential change in etiology. Presently Head and Neck cancer form the seventh most common cancer globally The primary treatment of oral cavity cancer comprises of surgery with adjuvant radiation with or without chemotherapy for locally advanced cancers or early-stage cancer in presence of high-risk factor. Cancers of the oropharynx are treated primarily with radiotherapy for early stage and chemoradiation for locally advanced disease. Laryngeal cancers are treated with either radiotherapy alone or chemoradiation, with surgery reserved for patients with laryngeal cartilage involvement or non-functional larynx.
Radiotherapy for head and neck cancer is delivered with conventional fractionation at 2- 2.2Gy per fraction to a total of 70 Gy dose equivalent. There are certain other altered fractionation types which has been tested like hyperfractionation with an intention to reduce late toxicities as well as accelerated and hypofractionation to counteract the effects of accelerated repopulation. Altered fractionation trials with hyperfractionation show increase in overall survival benefit when compared to radiotherapy alone but worse OS outcomes when compared to chemoradiation with lower toxicities. The advent of the COVID 19 pandemic popularised hypofractionated regimens with the ASTRO-ESTRO consensus statement which achieved a strong consensus about hypofractionated RT.
The addition of concurrent chemotherapy has been found to be superior compared to radiation alone in terms of locoregional control as well as overall survival. The MACH-NC meta analysis showed a 6.5% difference at 5 years and 3.6% at 10 years in favour of concurrent chemotherapy. The optimal dose of chemotherapy remains an important question. Although several studies have shown a significant improvement in overall survival with increasing cumulative cisplatin doses there might not be additional benefit of increasing dose of chemotherapy beyond a cumulative dose of 200mg/m2.
Through this study, the investigators aim to assess and compare the disease related outcomes, acute and late toxicities as well as the quality of life parameters of patients treated with hypofractionated radiotherapy along with two cycles 3 weekly concurrent chemotherapy versus those following the conventional chemotherapy regimen.
Rationale of study
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •ECOG performance status 0 -
- •Patients diagnosed with invasive squamous cell cancer of the head and neck region which includes lip, oral cavity, nasopharynx, oropharynx, hypopharynx, supraglottis, glottis and subglottis.
- •Patients who are being treated with curative intent treatment either with surgery followed by adjuvant radiotherapy with or without chemotherapy or definitive chemoradiation.
- •Patients must have a histopathological proof of malignancy, such as biopsy or post operative histopathology report. Biopsies or surgeries done outside must have been reviewed for pathological confirmation and specimen adequacy at the treating institute.
- •Patients with non metastatic cancer, optimally staged with the following:
- •Contrast enhanced CT scan of the neck and thorax for cancer lip, oral cavity, oropharynx, hypopharynx, supraglottis, glottis and subglottis
- •Magnetic Resonance Imaging of the neck and CT thorax for cancer of nasopharynx
排除标准
- •Concurrent illness like severe cardiac, renal or hepatic dysfunction and, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- •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
Patients reported outcomes in the form of EORTC QLQ C30 questionnaire at regular designated intervals using electronic patient reported outcome monitoring systems (e-PROMS). EORTC QLQ C30 stands for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30. The score will range from 0 to 100 as per the Scoring of the EORTC QLQ-C30 version 3.0. A higher score will denote a better quality of life.
次要结局
- To compare the locoregional control at 2 years between the hypofractionated and conventional arm.(2 Years)
- To compare acute and late toxicities of hypofractionated radiotherapy with conventional fractionation(2 Years)