Colorectal Carcinoma Clinical Trial
Official title:
Phase II Study on Curative Resectability of Not Optimally Resectable Liver and/or Lung Metastases From Colorectal Carcinoma (CRC) Under Intensified Chemotherapy (FOLFOXIRI/ Bevacizumab)
The purpose of this clinical trial is to primarily assess the efficacy of an intensified
chemotherapy consisting of a combination of FOLFOXIRI + bevacizumab. The main focus will be
laid on the rate of patients who achieve secondary complete (R0)-resectable metastases.
The FOLFIRI + bevacizumab as well as the FOLFOXIRI regimens have been shown previously to be
both effective in the treatment of advanced CRC with having manageable toxicities.
Therefore, an intensified chemotherapy combining these two standard regimens might be a
promising therapeutic approach improving the treatment of metastatic disease and outcome of
CRC.
Patients with advanced colorectal carcinoma of UICC stage IV, and liver and/or lung
metasta¬ses only, which are not optimally resectable, will be enrolled in this single-arm
phase II study.
A minimum of 4 cycles (=8 weeks) of chemo¬therapy prior to surgery is mandatory for all
patients. However, patients may withdraw from the study at any time upon their own request.
Treatment with preoperative chemothera¬py will continue until 2-4 weeks prior to surgery
with the last application of bevacizumab (only FOLFOXIRI) 4 weeks before surgery, at longest
16 cycles (= 32 weeks) for candidates not eli¬gible for surgery. Treatment will be
discontinued prematurely at disease progression or unacceptable toxicity.
As secondary endpoints the acute and perioperative toxi¬city of preoperative chemotherapy
according to NCI CTCAE v 3.0 including all peri-and post-surgical complications as well as
progression free survival and overall survival and quality of life will be assessed.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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