Phase II Clinical Trial of Capecitabine and Oxaliplatin Plus Bevacizumab as Neoadjuvant Treatment for Patients With Previously Untreated Unresectable Liver-only Metastases From Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Overall response rates
研究概览
简要总结
To evaluate the overall response rate of patients with previously untreated unresectable liver-only metastases from colorectal cancer treated with neoadjuvant capecitabine and oxaliplatin plus bevacizumab.
详细描述
No previous treatment.
The 21 day cycle of treatment will be given for four courses before being reassessed by MRI/CT for resectability of their liver metastases.
Those patients with stable disease or partial response, but are not yet resectable will continue for a further four courses of treatment before reassessment.
Patients whose liver metastases have become resectable will proceed to surgery after a 6 week break from the last administration of Capecitabine (8 weeks from the last administration of Bevacizumab).
A further four courses of treatment will be administered post-operatively to commence at least 8 weeks after surgery and when the patient is well recovered and healed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven diagnosis of colorectal adenocarcinoma
- •Metastatic disease present in the liver only.
- •Absence of extrahepatic metastases excluded by CT chest, abdomen and pelvis. Indeterminate CT findings may require verification by FDG-PET scanning.
- •Liver-only metastases determined to be unresectable at presentation on a pre-treatment liver MRI with an appropriate liver specific contrast (eg. TESLA) by a specialist multidisciplinary team (consisting of medical oncologist, hepatic surgeon and radiologist). Guidelines for determining unresectability include:
- •presence of >4 metastases;
- •size >5cm;
- •location and distribution of metastatic disease within the liver unsuitable for resection with clear margins (eg. Involvement of both lobes of liver; invasion of intrahepatic vascular structures);
- •extent of liver involvement precluding resection with adequate post-resection residual liver parenchyma volume for viable liver function in the immediate post-operative period;
- •inability to retain adequate vascular in flow and out flow to maintain viable liver function.
- •No previous treatment for metastatic colorectal cancer, including chemotherapy, targeted or experimental therapies (e.g. anti-VEGF or anti-EGFR), radiotherapy to the liver, or surgery or radiofrequency ablation to liver metastases.
- •Feasibility of surgery with curative intent:
- •If the primary colorectal tumour is in situ, the primary tumour must also be resectable with curative intent
- •Patients presenting with liver metastases only relapse after initially curative resection of their primary colorectal cancer followed by treatment with adjuvant chemotherapy may not be entered into the study if the relapse has occurred within 12 months of completion of adjuvant treatment
- •Adequate medical fitness to undergo neoadjuvant treatment and surgery with curative intent (hepatectomy +/- resection of primary tumour, if required)
- •Absence of pre-existing liver dysfunction of Childs Pugh Grade B or greater. Patients who are suspected of having pre-existing liver dysfunction due to clinical, biochemical or radiological findings, should have significant liver disease excluded by a liver biopsy prior to study entry.
排除标准
- 未提供
研究组 & 干预措施
This is a single arm study
This is a single arm study
干预措施: Capecitabine (Drug)
This is a single arm study
This is a single arm study
干预措施: Oxaliplatin (Drug)
This is a single arm study
This is a single arm study
干预措施: Bevacizumab (Drug)
This is a single arm study
This is a single arm study
干预措施: Liver metastasectomy (Procedure)
结局指标
主要结局
Overall response rates
时间窗: 12 months
次要结局
- Complete resection (R0) rate(12 months)
- Safety and feasibility of adding bevacizumab to neoadjuvant capecitabine and oxaliplatin in patients undergoing liver metastasectomy(12 months)
- Other parameters of efficacy (response and survival) in patients with unresectable liver-only metastases treated with this neoadjuvant combination(5 years)