Randomised comparative study between concomitant chemoradiotherapy with conventionalfractionation and hypofractionation radiotherapy in unresectable locally advanced carcinomaof the oral cavity.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Response assessment
研究概览
简要总结
Oral cavity cancer represents a significant subset of head and neck malignancies, encompassing tumours that arisein the lips, tongue, floor of the mouth, buccal mucosa, hard palate and gingiva. According to GLOBOCAN 2022, with 3,89,765 new cases, it is the 10th most common cancer in men and 15th most common cancer in women worldwide.In India, 1,43,759 new cases of lips and oral cavity cancers were recorded, which accounts for almost 36% of all global cases, making it a significant public health concern.The majority of patients in India present at advanced stages, limiting surgical resection options and necessitating aprimary role for radiation therapy in the curative or palliative setting.
The proposed study is a prospective, comparative, single institute based study. A convenient sampling method shall be applied for patients diagnosed with Oral cavity squamous cell carcinoma who received prior induction chemotherapy and will be undergoing either concomitant chemo-radiotherapy with conventional fractionation or hypo fractionated radiotherapy at the Department of Radiotherapy in IPGME&R and SSKM Hospitals, Kolkata, West Bengal.
This study aims to provide a comprehensive and rigorous framework for comparing conventional fractionation and hypo fractionation in the management of inoperable oral cavity cancer, with the ultimate goal of informing evidence- based clinical practice. It is expected to compare the two arms in terms of loco regional control and Progression free survival (PFS) and also study the toxicities associated with the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All histological and/or cytological proven cases of primary malignancy of Squamous cell carcinoma of the oral cavity.
- •Unresectable and Locally advanced disease.
- •Age between 18 to 70 years, with Performance Status ECOG 0,1,
- •Previously untreated for any type of cancer.
- •Normal haematological parameters.
- •Patients willing to participate in the study with a written and informed consent.
排除标准
- •Previous history of Radiotherapy in Head and Neck region.
- •Patients with collagen vascular disease or any other systemic comorbidities or severe uncontrolled infection, which may alter treatment outcome.
- •Pregnant or nursing women.
- •Patients who had impaired liver function, bone marrow suppression & renal dysfunction.
- •Recurrent disease.
结局指标
主要结局
Response assessment
时间窗: at baseline, after completion of radiation, at 3 months, at 6 months, at 9 months, at 12 months.
次要结局
- Assessment of Toxicities(at baseline, after completion of radiotherapy, 3 months, 6 months, 9 months, months)