Perioperative Chemotherapy With FOLFOX Plus Cetuximab Versus Adjuvant FOLFOX Plus Cetuximab for Patients With Resectable Liver Metastases of Colorectal Carcinoma
In recent years chemotherapy based on FOLFOX and cetuximab has become a standard treatment
in patients with colorectal liver metastases. Recently, the analysis of the CELIM trial
reported response rates of 70% in patients with initially unresectable colorectal liver
metastases treated with FOLFOX + Cetuximab. 46% of the patients had their metastases R0 or
R1 resected or a ablation by radiofrequency with an overall 34% R0 resection rate. In recent
studies, adjuvant chemotherapy with FOLFOX leads to a prolongation of disease free survival
after successful resection of colorectal liver metastases, but there is not sufficient data
concerning a perioperative regimen. In only one study of Nordlinger et al. a trend in
progression-free survival could be reached in patients receiving a perioperative
FOLFOX-therapy, but without reaching statistical significance. Furthermore those patients
displayed a significantly higher rate of postoperative complications and morbidity. Although
the advantages of perioperative treatment are not proven, this concept has become more and
more popular in recent years, mainly because of a lack of guidelines. Thus the aim of our
study is to compare the complication rate of both therapeutical concepts. Furthermore,
secondary objectives (disease-free survival, overall survival, resection rates, response
rates, toxicities and quality of life) will be used to estimate the efficacy, feasibility,
and safety of both regimens. Perioperative treatment probably has a better efficacy in
patients with high tumor burden (>3 liver metastases or one metastasis > or = 5 cm in
diameter) with effect on disease free survival and will be investigated in a subgroup
analysis.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Clavien score (> grade 1)
The first primary objective of the study is to compare the postoperative complication rate according to Clavien score (> grade 1) of a perioperative chemotherapy with a postoperative regimen
1 year
Yes
Ulf P Neumann, Prof.
Study Director
RWTH Aachen University Hospital
Germany: Federal Institute for Drugs and Medical Devices
CTC-A10-005
NCT01266187
July 2011
January 2020
Name | Location |
---|