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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
intensified chemotherapy (FOLFOXIRI/Bevacizumab)
NCT
Heidelberg, Germany
surgically complete resectability; S-CR
To evaluate the proportion of patients who achieve surgically complete resectability (S-CR) of metastases after preoperative chemotherapy.
Time frame: 12 month after Surgery
Evaluate the acute and perioperative toxicity of preoperative chemotherapy according to NCI CTCAE v3.0 and all peri-and post-surgical complications
Descriptive analysis is performed to identify treatment side effects and their individual impact from the patients' perspective, as well as changes during treatment based on BELISPO questionnaire data.
Time frame: 12 month after surgery
Survival rate (OS) and progression free survival (PFS)
The PFS is calculated for all patients. It is defined as the time from admission to the study to objective tumor progression or death from any cause, whichever occurs first. OS is defined as the time from registration to death from any cause.
Time frame: 12 months after surgery or end of treatment.
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