Treatment Regimens for Patients With Resectable Liver Metastases (PANTER Study)

Liver Metastasis Clinical Trial

Official title: Perioperative Chemotherapy With FOLFOX Plus Cetuximab Versus Adjuvant FOLFOX Plus Cetuximab for Patients With Resectable Liver Metastases of Colorectal Carcinoma

Status Terminated

Clinical Trial Summary

Is a perioperative chemotherapy based on FOLFOX and Cetuximab (K-RAS wild-type) associated with a higher rate of postoperative complications in patients with resectable colorectal liver metastases as compared to only adjuvant FOLFOX and chemotherapy? Are there any differences for disease free survival between periand postoperative treatment in patients with >3 liver metastases or at least one metastasis > or = 5 cm in diameter?

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis

• NCT number: NCT01266187
• Study type: Interventional
• Source: RWTH Aachen University
• Status: Terminated
• Phase: N/A
• Start date: July 2011
• Completion date: September 2015