Role of Intra-arterial Neoadjuvant Chemotherapy in the management of advance staged oral squamous cell carcinoma.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Clinical and radiological response to chemotherapy.
研究概览
简要总结
This prospective pilot study focuses on the shrinkage of disease/tumor in non-operable advance staged oral squamous cell carcinoma (mouth cancer). The chemotherapy drugs will be given through intra-arterial (IA) route as compared to standard approach of giving drugs through intravenous route (IV). The advantage of given intra-arterial drug is that the drugs will be delivered directly to the tumour site which is likely to have better chance of shrinkage as compared to IV route where drug is given in to the whole system and then drug distributes to whole body including tumor site. By doing this approach we have to go through artery in leg to reach the targeted site at face. This procedure will be performed in sterile and controlled environment at Cath lab. This will be performed by experts and patients will be followed up as mentioned in the research protocol. We intend to check the feasibility and outcome of this procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with confirmed diagnosis of advanced-stage (IVa/IVb) OSCC and surgically inoperable
- •Patients aged 18–80 years old will be included in the study.
- •Patients expected to comply with the protocol 4.Patient willing to enroll in the study.
排除标准
- •Patients with a history of previous treatment (surgery, chemotherapy, or radiotherapy) of oral cancer.
- •Pregnant patient, lactating mother or planning to be pregnant
- •Drug abusers or any other substance abuse
- •Patient with any psychiatric disorder or undergoing any psychiatric treatment
- •Patients with terminal illness whose prognosis of survival is less than a year.
结局指标
主要结局
Clinical and radiological response to chemotherapy.
时间窗: Pre-intervention, | 2 weeks after the second cycle of chemotherapy, | 2 weeks after 3rd Cycle (if given)
次要结局
- Toxicity assessment(Histopathological response.)
研究者
Dr Anand Gupta
Govt medical college hospital Chandigarh