An independent data monitoring committee (IDMC) will assess: 1. after metastasectomy or resection in combination with RFA. In both arms patients will be assessed for recurrence/new occurrence of colorectal cancer by chest CT, abdominal CT and CEA measurement. Patients will be assessed after surgery but before randomization, thereafter every three months after surgery in the first two years and every 6 months until 5 years after surgery. In case of a confirmed recurrence/appearance of new colorectal cancer, patients can be treated with surgery or any subsequent line of chemotherapy and will be followed for survival until the end of study follow up period as well. The primary endpoint is usually disease free survival. Secondary endpoints are overall survival, safety and quality of life. Conclusion The HEPATICA study is designed GSK 4027 to demonstrate a disease free survival benefit by adding bevacizumab to an adjuvant regime of CAPOX in patients with colorectal liver metastases undergoing a radical resection or resection in combination with RFA. Trial Registration ClinicalTrials.gov Identifier NCT00394992 Background Colorectal cancer (CRC) is the second leading cause of cancer-related-deaths in the western world. The incidence of CRC is still GPC4 increasing [1-3]. About 50% of patients with progressed colorectal cancer develop liver metastasis . The pathway from colon to liver metastases is usually via the portal vein and liver metastases are usually the first metastases to appear, often without signs of systemic dissemination meaning possibility of cure for these patients . The median survival of patients with colorectal liver metastases is usually 6-12 months if untreated [6,7]. Complete surgical resection is the only treatment modality that offers hope for cure, resulting in 5 year survival for 36-60% [8-11]. Improved imaging, and surgical techniques as well as neoadjuvant therapy have increased the number of patients receiving R0 resection for colorectal liver metastasis. R0 resection is usually defined as a resection with tumor free margins as confirmed by the pathologist. Liver resection is a relatively safe procedure with mortality rates less that 5% [12,13]. Unfortunately only approximately 25% of patients are resectable at time of presentation. Radiofrequency ablation (RFA) is an alternative treatment option with promising five year survival rates for patients GSK 4027 with small ( 4 cm) colorectal liver metastases. There are few studies reporting long term survival after RFA ranging from 18-30% [14-19]. The success rate of RFA greatly depends on size and open approach of the tumors treated as shown in GSK 4027 a large meta-analysis examining 5224 treated tumors . In all abovementioned studies, treated tumors had a mean diameter of less than 5 cm and patients did not have more than 3 tumors per patient on average. Surgical resection or RFA of CRLM alone is obviously not sufficient as 40%-70% of patients will develop local or distant recurrences after surgery of colorectal liver metastasis. Different clinical studies comparing medical procedures and systemic adjuvant therapy with surgery and observation demonstrate a benefit in disease free survival (DFS) for the treatment arm [21-24]. Adding chemotherapy after resection might prevent the outgrowth of micrometastases present in the liver at the time of resection . Portier and colleagues published the results of the first GSK 4027 randomized controlled phase III study comparing medical procedures with observation with surgery and adjuvant chemotherapy.
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- 2 Dual mTOR inhibitors inhibit bladder cancer cell growth in a dose-dependent manner
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