Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT01540435
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT01540435
Study Brief:
Protocol Section:
NCT01540435