Colon Cancer Liver Metastasis Clinical Trial
Official title:
Perioperative FOLFOXIRI and Bevacizumab Compared With Postoperative FOLFOX in Patients With Resectable Liver Metastases From Colorectal Cancer (PERIMAX). A Randomized, Multidisciplinary DGAV(CAO-V/CALGP)/AIO Phase II Trial
This randomized, controlled, multicenter, non-comparative phase II trial compares an intensified perioperative treatment of patients with resectable synchronous or metachronous colorectal liver metastases to primary surgery and adjuvant systemic chemotherapy.
Recurrence rates after R0-resection of colorectal liver metastases are still very high
(about 60-70 %). Therefore, multidisciplinary treatment of these patients is frequently used
in order to achieve a beneficial impact regarding progression-free and overall survival. The
point in time of treatment, pre- and/or postoperative, is still a matter of debate. In the
EORTC 40983 trial, perioperative chemotherapy with 5-Fluorouracil and oxaliplatin
(FOLFOX-Regimen) displayed a non-significant benefit in 3 year disease free survival in the
intent to treat population (HR 0.79, 95% CI 0.62 to 1.02) (Nordlinger, Sorbye et al. 2008).
The combined analysis of two adjuvant trials, with a (non-contemporary) 5-FU Bolus regimen,
showed a non-significant prolongation of median disease free survival (DFS) from 18.8 to
27.9 months (p=0.058) and OS from 47.3 to 62.2 months (p=0.095) (Mitry, Fields et al. 2008).
However, postoperative treatment with 6 months of FOLFOX is often used in daily practise.
Thus, further investigation is urgently warranted.
This phase II trial evaluates two strategies with intensified perioperative or postoperative
treatment regimens. Current studies established the role of the FOLFOXIRI regimen in the
metastatic setting (Falcone, Ricci et al. 2007). A further intensification of a three drug
regimen with bevacizumab seem to be feasible yielding response rates up to 84% and a disease
control rate up to 100% (Falcone 2008; Bruera, Santomaggio et al. 2010; Masi, Loupakis et
al. 2010). Regarding the efficacy, evaluation of FOLFOXIRI and bevacizumab in preoperative
treatment for resectable CLM seems to be promising. Postoperative treatment with FOLFOX for
6 months was chosen for arm A.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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