Treatment Outcome of Patients with Regionally Advanced Head and Neck Squamous Cell Carcinoma with Clinical Extranodal Extension Treated with Definitive Chemoradiation: A Prospective Single-Arm Study
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Department of Radiation Oncology BBCI
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To assess the progression-free survival (PFS) at 2 year
概览
简要总结
Head and Neck Squamous Cell Carcinoma (HNSCC) is among the most common cancers in India, with a high burden in the North Eastern region. A large proportion of patients present with locally advanced disease involving lymph nodes with extranodal extension, which is classified as clinical N3b according to AJCC 8th edition. This subset carries a poor prognosis, and there is no established standard of care for patients with clinical N3b disease.
This prospective single arm study aims to evaluate treatment outcomes in patients with locally advanced inoperable head and neck squamous cell carcinoma with clinical extranodal extension treated with definitive concurrent chemoradiation using modern conformal radiotherapy techniques.
Eligible patients aged 18 to 70 years with ECOG performance status 0 or 1 and histologically confirmed squamous cell carcinoma of oropharynx, hypopharynx or larynx with clinical N3b status will be included. Patients with prior head and neck radiotherapy, renal dysfunction or ulcerated nodes will be excluded.
All patients will receive Volumetric Modulated Arc Therapy (VMAT) based radiotherapy to a total dose of 66 Gray to the high risk volume, 60 Gray to intermediate risk and 54 Gray to low risk volumes in 30 fractions over six and a half weeks. Concurrent weekly cisplatin at 40 milligrams per square meter will be administered to achieve a cumulative dose of at least 200 milligrams per square meter.
The primary endpoint is two year progression free survival. Secondary endpoints include treatment related toxicity assessed by CTCAE version 5.0, quality of life assessment using EORTC QLQ C30 and HN35 questionnaires, and analysis of prognostic factors such as age, sex, nodal size and HPV status.
Sample size is 45 patients, based on an expected improvement in two year progression free survival from 7.5 percent in historical data to 25 percent with modern radiotherapy. Statistical analysis will use Kaplan Meier method and log rank test.
The study will be conducted in the Department of Radiation Oncology, Dr B Borooah Cancer Institute, Guwahati. Data will be monitored by the institutional Data Monitoring and Safety Unit. The study is expected to generate evidence on the role of advanced radiotherapy in improving outcomes for patients with regionally advanced head and neck cancer with extranodal extension.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically confirmed inoperable SCC of oropharynx, hypopharynx, or larynx with cN3b nodal status.
- •ECOG performance 0–1
- •Age 18–70 years
- •Written Informed Consent Obtained.
排除标准
- •Nodal disease with skin ulceration/fungation/bleeding
- •Prior Radiotherapy for head and neck area
- •Deranged renal function at baseline (Creatinine Clearance less than 50 ml/min)
- •Cases with radiological evidence of Cartilage or Bony Erosion
- •Baseline Non-Functional Larynx based on FEES Test
- •Unable to come for follow-up as per study protocol.
结局指标
主要结局
To assess the progression-free survival (PFS) at 2 year
时间窗: To assess the progression-free survival (PFS) at 2 year
次要结局
- To estimate treatment related toxicities during radiotherapy, at completion and at every follow up using CTCAE 5.0 scale(During and at the end of Radiotherapy- Oral mucositis, Dermatitis, Dysphagia, Acute Xerostomia, Neutropenia, Thrombocytopenia, Anaemia, Electrolyte imbalance)
- To measure the QOL using instruments (Validated QOL Instruments)(EORTC QOL tool QLQ-C30 Quality of Life of Cancer Patients (in English and Assamese))
- To estimate various prognostic factors associated with treatment response eg. Age, Gender, Size of the Node, T-stage, HPV status for oropharyngeal primary, history of smoking, alcohol consumption etc.
- to estimate the Patterns of Failure:-(1. Locoregional Failure)
研究者
Dr Jyotiman Nath
Dr. B. Borooah Cancer Institute, Guwahati, Assam