Journal
BMC CANCER
Volume 15, Issue -, Pages -Publisher
BMC
DOI: 10.1186/s12885-015-1199-8
Keywords
Colorectal liver metastases; Neo-adjuvant chemotherapy; Surgical resection; Clinical risk score
Categories
Ask authors/readers for more resources
Background: Efforts to improve the outcome of liver surgery by combining curative resection with chemotherapy have failed to demonstrate definite overall survival benefit. This may partly be due to the fact that these studies often involve strict inclusion criteria. Consequently, patients with a high risk profile as characterized by Fong's Clinical Risk Score ( CRS) are often underrepresented in these studies. Conceptually, this group of patients might benefit the most from chemotherapy. The present study evaluates the impact of neo- adjuvant chemotherapy in high- risk patients with primary resectable colorectal liver metastases, without extrahepatic disease. Our hypothesis is that adding neo- adjuvant chemotherapy to surgery will provide an improvement in overall survival ( OS) in patients with a high- risk profile. Methods/ Design: CHARISMA is a multicenter, randomized, phase III clinical trial. Patients will be randomized to either surgery alone ( standard treatment, arm A) or to 6 cycles of neo- adjuvant oxaliplatin- based chemotherapy, followed by surgery ( arm B). Patients must be = 18 years of age with liver metastases of histologically confirmed primary colorectal carcinoma. Patients with extrahepatic metastases are excluded. Liver metastases must be deemed primarily resectable. Only patients with a CRS of 3- 5 are eligible. The primary study endpoint is OS. Secondary endpoints are progression free survival ( PFS), quality of life, morbidity of resection, treatment response on neo- adjuvant chemotherapy, and whether CEA levels can predict treatment response. Discussion: CHARISMA is a multicenter, randomized, phase III clinical trial that will provide an answer to the question if adding neo- adjuvant chemotherapy to surgery will improve OS in a well- defined high- risk patient group with colorectal liver metastases.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available