Assessing Efficacy of Neoadjuvant Chemoradiotherapy as a Treatment Plan for Patients With Stage IVa Oral Cancer.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Oral cancer is the single largest cancer in males in India. 90-95% cases of oral cancer are Squamous cell carcinomas and many of them present at late stages (T3 and above). Treatment of OSCC includes single modality surgery, radiotherapy, or combinations of these modalities with or without systemic therapy. For unresectable cases, radiotherapy and/or chemotherapy is the treatment modality. Efficacy of neoadjuvant chemoradiotherapy for resectable stage IV tumors (late stage) needs to be evaluated to assess its benefit before surgery.
详细描述
This study will assess the benefit of preoperative adjuvant chemoradiotherapy in patients with an Stage IVa oral squamous cell carcinoma (OSCC). The study population will consist of patients who have not been treated previously. Patients satisfying the inclusion-exclusion criteria will be included in the study after obtaining a valid, written and informed consent. After reviewing the histopathological report, the patients will be treated as per the study protocol. The patients will be under regular follow-up with 3 monthly intervals for a period of one year and 6 monthly period in the following years. At each follow-up, patients will be evaluated clinically for evidence of locoregional tumor recurrence. The locoregional recurrence-free survival will be calculated based on the difference between the date of inclusion and the date of biopsy-proven recurrence. We will also record the overall survival, parameters like trismus, osteonecrosis and xerostomia. Quality of life will be assessed at a regular interval of 1 year using the University of Washington Quality of Life Questionnaire (UW-QOL v.4)
Study protocol:
- Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys
- Three weekly concurrent chemotherapy with cisplatin 100 mg /m2
- Initial surgery in leg for Prefabrication of fibula - 2 weeks after starting of radiotherapy treatment. Delay is required for planning of implant position in the fibula.
- Definitive surgical procedure with reconstruction by prefabricated flap, 6 weeks post radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed stage IVa squamous cell carcinoma of the oral cavity.
- •Surgically resectable oral squamous carcinoma with invasion of mandible or maxilla.
- •Newly diagnosed or previously untreated squamous cell carcinoma of the oral cavity.
排除标准
- •Patients with distant metastases.
- •Patients with contraindication to radiotherapy.
- •Patients with vascular disorders or ischemic heart disease. -
研究组 & 干预措施
Neoadjuvant chemoradiotherapy followed by surgery
Preoperative chemotherapy with concurrent radiotherapy followed by definitive surgery
干预措施: Neoadjuvant chemotherapy (Drug)
Neoadjuvant chemoradiotherapy followed by surgery
Preoperative chemotherapy with concurrent radiotherapy followed by definitive surgery
干预措施: Neoadjuvant radiotherapy (Radiation)
Neoadjuvant chemoradiotherapy followed by surgery
Preoperative chemotherapy with concurrent radiotherapy followed by definitive surgery
干预措施: Resection and reconstruction (Procedure)
结局指标
主要结局
Objective response rate
时间窗: Upto 1 year
This will be deduced from pathological response in terms of complete and partial response. Complete response is defined as no invasive and no in situ residuals present in the surgical specimen. Partial response defined as at least a 30% reduction in the size of the lesion in the surgical specimen.
Disease free survival
时间窗: 2 years
Disease-free survival will be calculated as the time interval (months) between primary treatment and the first recurrence (whether local, regional or distant).
Overall Survival
时间窗: 2 years
Overall Survival will be calculated as the time interval (months) between primary treatment and death.
次要结局
- Quality of life assessment(2 years)
研究者
Dr. Sanjay Deshmukh
Surgical Oncologist
Indrayani Hospital and Cancer Institute