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 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT01442935
Brief Summary:
The main objective is to compare resection rates (R0 or R1) for hepatic metastases in the experimental arm (tri chemotherapy plus targeted therapy) versus the control arm (bi chemotherapy plus targeted therapy); in both arms the targeted therapy is selected according to K-Ras status of the patient's tumor.
The secondary objectives are to evaluate the objective response rate (CR and PR) after 4 cycles of treatment, according the RECIST V1.1 evaluation scale.
* the rate of complete remission (CR) at 6 months after the last study treatment (hepatic surgery or last chemotherapy cycle).
* the specific rates of resection R0, R1, R2.
* the complete pathological response Rate,
* the relapse-free survival rate in (R0 or R1) resected patients,
* the response duration in non-resected patients,
* the toxicity according to CTC AE V4 scale except for the neurotoxicity that will be evaluated with the Levi scale,
* the post operative complications using the DINDO classification,
* the progression-free survival (PFS) and overall survival (OS).
The objectives of the biological study are:
* to evaluate tumor-related predictive factors such as somatic mutations (KRAS, BRAF, TP53) and genetic amplification related factors (EGFR),
* to evaluate patient-related predictive factors in connection with genetic polymorphisms (Fc gamma and VEGF receptors),
* to evaluate ADCC activity via immunohistochemistry in order to analyze the lympho free and progression-free survival,
* to study circulating of tumor cells as prognostic factor for metastatic colorectal cancer, non- resectable at presentation.
Study:
NCT01442935
Study Brief:
Protocol Section:
NCT01442935