A phase II study for PREServing TOngue with Neoadjuvant chemoimmunotherapy and chemoradiation in advanced tongue cancers: PRESTO study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- To assess the efficacy and safety of neoadjuvant chemoimmunotherapy and chemoradiation for tongue preservation in patients requiring a major glossectomy
研究概览
简要总结
Advanced tongue cancers are treated with surgery (which involves removal of the affected part of tongue) and removal of lymph nodes from the neck. This is followed by 6-7 weeks of radiation therapy (RT) (a form of cancer treatment which involves killing of cancer cells with high energy X-rays). Chemotherapy (medicines used to kill cancers cells) can be combined with RT to increase the effect of RT. This is called as CTRT.
Removal of large part of tongue followed by RT/ CTRT leads to problems which impact the day to day life of many patients after treatment. These include swallowing difficulty, unclear speech, loss of taste etc.
Immunotherapy is a relatively new form of cancer treatment which enhances the capability of body to destroy cancer cells. It is available as a medicine similar to chemotherapy
In this study we are combining chemotherapy, immunotherapy and RT in an attempt to preserve your tongue. We will first give patients with advanced tongue cancer a combination of chemotherapy and immunotherapy. After this in patients a good amount of reduction in the cancer, we will offer these patients CTRT. Hence, in these patient’s surgery will be omitted.
We believe that with this approach, we will be able to preserve the tongue in a significant number of tongue cancer patients who otherwise would have required removal of large parts of their tongue. We also believe that with this approach patients will be able to have a much better quality of life after treatment without impacting the cancer control rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Stage III/ Stage IV (AJCC 8th edition) Squamous Cell Carcinoma of Tongue
- •Upfront Resectable (as deemed by a DMG surgeon)
- •N stage: N0-N2c (AJCC 8th edition)
- •Requiring Major Glossectomy (Type IV/ Type V-Ansarin Classification) (22)
- •With CPS score more than equal to 1 on Bx (IHC).
排除标准
- •1.N3a/N3b tumors (AJCC 8th edition) 2.Unresectable at baseline 3.Recurrent Tumors 4.Having Received other cancer-directed treatment 5.Verrucous lesions.
结局指标
主要结局
To assess the efficacy and safety of neoadjuvant chemoimmunotherapy and chemoradiation for tongue preservation in patients requiring a major glossectomy
时间窗: 1 year
次要结局
- To identify a subgroup of Indian oral cavity cancer patients who have a good response to Neoadjuvant chemoimmunotherapy(2.5 years)
研究者
Dr Shwetabh Sinha
TATA MEMORIAL HOSPITAL