Neoadjuvant treatment versus upfront surgery in Resectablepancreatic cancer (NEVUS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of margin negative resection, defined as the absence of viable tumor cells more than 1 mm from the inked surgical margin
研究概览
简要总结
Introduction :Stereotactic body radiotherapy is high precision radiotherapy where radiobiologically very high and efficient doses can be delivered. SBRT can be given over 5-10 days and the biologically equivalent dose appears to be higher than conventional fractionation schedules which is given over 5-6 weeks. This is also more convenient to patients and in case of resectable pancreatic cancer SBRT will not delay surgery significantly. May result in improved increased rates of R0 resection and hence may result in improved of local control and survival
Staging and baseline evaluation:
- Baseline Triphasic CECT scan of the abdomen delineating the relation of the tumor with the vessels & the duodenum defined to be resectable as per the NCCN guidelines ( Version 2.0 )
- Baseline CEA ( Carcinoembryoinic antigen ) & CA-19.9( Carbohdrate antigen)
- CBC, LFT,RFT, total protein and albumin
Assessment of response to neoadjuvant therapy was based on Triphasic contrast enhanced restaging CT scans 6 weeks after completion of SBRT
Treatment:
Patients will undergo upfront surgery alone or SBRT followed by 2 cycles of chemotherapy and then surgery as per Institutional guidelines. Patients being randomized to upfront surgery arm (ARM A) will not require a tissue diagnosis, however histopathological confirmation would be required only if the tumor is not well appreciated or is considered doubtful as per the Triphasic CECT scan findings.
A mandatory histological confirmation of adenocarcinoma pancreas would be required in experimental arm ( ARM B) prior to the start of therapy.Acute toxicity and adverse effects would be reported using the CTCAE VERSION 5(Appendix) recommendations for classifying acute toxic effects of radiotherapy
1) ARM A (Standard ARM) – Upfront surgery
Patients randomized to upfront surgery will undergo Whipples procedure. Vascular resection will be done if required
2) ARM B (Experimental ARM) -SBRT followed by 2 cycles of FOLFIRINOX
The following procedures would be done
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Radiologically defined to be resectable as per the NCCN guidelines Version 2 on a Triphasic CECT scan amenable to oncological surgical resection.
- •Selected ampullary adenocarcinomas involving pancreatic head or abutting or involving vessels will be included.
- •Patients with no evidence of regional or distant metastatic disease based on CT scan of the chest/ abdomen/pelvis -No significant co-morbidities that would interfere with treatment and fit for general anaestheia -Reliable for follow-up and signed informed consent.
- •Karnofsky performance status (KPS) between 70 and
- •Patients with tumors primarily of the body or tail of the pancreas requiring a distal pancreaticoduodenectomy.
排除标准
- •Prior surgical resection of any pancreatic malignancy -Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields -History of prior allergic reactions attributed to compounds of CT or MRI contrast -Any prior therapy for pancreatic cancer.
结局指标
主要结局
Incidence of margin negative resection, defined as the absence of viable tumor cells more than 1 mm from the inked surgical margin
时间窗: 48 months
次要结局
- -Median overall survival(-Pathological response)