A PROSPECTIVE RANDOMISED STUDY TO COMPARE SEQUENTIAL SHORT COURSE RADIOCHEMOTHERAPY VERSUS CONCURRENT LONG COURSE CHEMORADIOTHERAPY BEFORE TOTAL MESORECTAL EXCISION IN LOCALLY ADVANCED RECTAL CANCER.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.To compare the local disease control rate with these two treatments.
研究概览
简要总结
Total neoadjuvant therapy (TNT) versus neoadjuvant therapy (NAT) is debated topic. But the recent work in some studies on LARC showed that the disease related treatment failure chances were decreased in patients receiving TNT in comparison to “standard neoadjuvant therapy (NAT)â€. Total neoadjuvant therapy also lowers the risk of distant metastasis. Time taken between completion of “total neoadjuvant therapy†and surgery in patients with LARC is still under investigation. But the time gap of 8-12 weeks is associated with better pathological response. So, we in this study aim at decreasing the risk of distant metastasis without increasing the risk of LRR rates, thus ultimately improving survival outcomes and quality of life of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Biopsy proven case of locally advanced rectal adenocarcinoma
- •Pelvic MRI has atleast one the following features: (i)Clinical tumour stage cT3, cT4a or cT4b (ii)Nodal stage cN1, cN2 (iii)Involvement of mesorectal fascia.
排除标准
- •1.Metastatic disease 2.Recurrent rectal cancer 3.Uncontrolled medical comorbidities.
结局指标
主要结局
1.To compare the local disease control rate with these two treatments.
时间窗: At completion of treatment and at 3 months after treatment.
2.To compare the pathological complete response rate in two treatment groups.
时间窗: At completion of treatment and at 3 months after treatment.
次要结局
- To compare the acute and chronic toxicities with these two treatment arms.(During treatment and at 3 months after treatment.)
研究者
DR AJAY KUMAR BANSAL
Post graduate institute of medical education and research chandigarh