CTRI/2022/09/045291尚未招募4 期
A Prospective Randomized Study Comparing Total Neoadjuvant Treatment Followed by Total Mesorectal Excision (TME) and Conventional Long Course Chemoradiotherapy Followed By TME And Adjuvant Chemotherapy in Locally Advanced Rectal Cancer
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- •Pathological response in resected specimen: pCR, R0, R1
研究概览
简要总结
| **NEED FOR STUDY:**As per GLOBOCAN 2018 data, colorectal carcinoma (CRC) is the third most commonly diagnosed cancer in the world comprising about 10.1 % of all new cancer diagnoses as per the registry and second in mortality (9.2%) lagging only to lung caner1. Rectal cancer alone constitutes about 40% of cases of CRC. Rectal cancer treatment remains challenging not only for clinicians but also for patients. Most of cases in rectal cancer are diagnosed in locally advanced stages in developing countries. For locally advanced rectal cancer (LARC) patients, multimodal treatment consisting of neoadjuvant chemoradiotherapy (CRT) followed by total mesorectal excision (TME) surgery and adjuvant chemotherapy has become the standard of care2. As per Gollins et al, Five years local recurrence rate has reduced from more than 25% to about 5-10% due to improved surgical and neoadjuvant treatment but distant metastatic recurrence still remains around 30%, which remains the leading cause of cancer-related mortality3. The standard treatment models have also resulted in tumor downstaging, and improved quality of life but pathological complete response (pCR) is seen in 10-30% of patients only4. In a German phase 3 trial, Adjuvant chemotherapy following conventional long course chemoradiotherapy (CRT) has poor tolerability and less than 50 to 60 % of patients came for adjuvant treatment out of that only 40% complete the scheduled treatment5,6. A novel therapeutic approach, total neoadjuvant therapy (TNT) had tried to overcome such problems. This new treatment strategy is used to deliver both radiotherapy and systemic chemotherapy prior to surgery. In UNICANCER-PRODIGE 23 phase 3 trial, The compliance with TNT is more than 90% and most of the patients received the scheduled treatment without higher toxicities compared to CRT7. pCR rates with TNT are higher (20-40% when compared with CRT (10-20%). Here, we are proposing this study in cases of advanced rectal carcinoma for comparing perioperative complications and pathological outcomes in two groups. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 to 75 years
- •Newly diagnosed locally advanced primary resectable rectal adenocarcinoma on biopsy without distant metastases
- •Lower border of tumour ≤ 15 cm from Anal Verge
- •High risk features on MRI: any one of below T3 anyN M0, T4 any N M0, anyT N1+ M0, Threatened CRM, MRF involvement, Extramural vascular invasion
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0–2
- •Written informed consent.
排除标准
- •Extensive tumor growth leading to primarily unresectable eg.
- •Tumor involving lumbosacral nerve root, tumor involving lateral pelvic wall, tumor involving sacrum S3 and above
- •Recurrent rectal cancer
- •Partially treated patients
- •Concomitant malignancy
- •History of peripheral neuropathy
- •History of Cardiac disease / Stroke
- •Chronic kidney disease
- •Chronic liver disease with bilirubin more than 2 mg/dl
- •Pregnant or breast-feeding women.
结局指标
主要结局
•Pathological response in resected specimen: pCR, R0, R1
时间窗: post recruitment of study patients with completion of treatment, all patients will analyzed for primary outcome.
次要结局
- •Disease free survival (DFS) and overall survival (OS)(•Effect of neoadjuvant treatment: Efficacy and safety, tolerability and toxicity, compliance and Completion of scheduled treatment)
研究者
研究点 (1)
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