Recruitment

Recruitment Status
Terminated
Estimated Enrollment
60

Inclusion Criterias

Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception.
Extra hepatic metastatic location is limited to 1 site.
Female or male patients with at least 18 years at the time the informed consent is signed
...
Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception.
Extra hepatic metastatic location is limited to 1 site.
Female or male patients with at least 18 years at the time the informed consent is signed
Partial and minor resection of metastatic disease is allowed within 3 months before inclusion if patient has never received chemotherapy for mCRC.
Life expectancy of at least 3 months without any active treatment.
Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception.
Patients with potentially resectable metastatic disease at diagnosis and for whom a chemotherapy first in a curative intent is recommended . Resectability could be planed in one or multiple stage if indicated. As commonly admitted, resectability means the surgical clearance (+/- radiofrequency ablation) of all detectable (liver) lesions with tumor-free margins and compatible with an adequate hepatic reserve. Practically, bilateral tumor location, number and location of lesions, and inadequate hepatic reserve remain the main decisional factors.
ECOG performance status 0 or 1
Patients may have received adjuvant chemotherapy or (neo-) adjuvant chemo-radiotherapy to the pelvis, provided the last dose of chemotherapy was administered at least 6 months prior to inclusion (12 months for oxaliplatin). Previous radiotherapy to the pelvis is not an exclusion criterion.
Histological or cytological confirmed diagnostic of adenocarcinoma of the colon or rectum, with or without primary tumour in situ. Wild-type RAS and B-RAF tumor status.

Exclusion Criterias

7.Prior major liver resection: remnant liver < 50% of the initial liver volume.
2.Prior chemotherapy or systemic therapy for mCRC. Adjuvant chemotherapy for colorectal cancer is not an exclusion criterion provided that it was completed more than 6 months prior to inclusion. Oxaliplatin-based chemotherapy must be completed more than 1 year prior to inclusion.
9.Concurrent central nervous systems metastases
...
7.Prior major liver resection: remnant liver < 50% of the initial liver volume.
2.Prior chemotherapy or systemic therapy for mCRC. Adjuvant chemotherapy for colorectal cancer is not an exclusion criterion provided that it was completed more than 6 months prior to inclusion. Oxaliplatin-based chemotherapy must be completed more than 1 year prior to inclusion.
9.Concurrent central nervous systems metastases
12.Pregnant or breast feeding.
10.Peripheric neuropathy ≥ grade 2.
8.Non-malignant disease that would render the patient unsuitable for treatment according to this protocol.
13.The patient has previous or concomitant malignancies, except: Invasive malignancies in remission for more than 5 years and non melanoma skin cancer or carcinoma in situ of the cervix.
1.Definitively non resectable mCRC at diagnosis
5 Non mesurable disease( RECIST 1.1 criteria)
3.Prior utilization of cetuximab, panitumumab (or other anti-EGFR (epidermal growth factor receptor)therapy).
11.Interstitial lung disease
4.Previous radiotherapy delivered to the upper abdomen.
6.Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment.

Summary

Conditions
Metastatic Colorectal Cancer
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This is a phase II , openlabel, randomized study in patients with confirmed diagnosis of potentially or borderline resectable metastatic colorectal adenocarcinoma (RAS and B-RAF WT tumors ), who have not received prior chemotherapy for their metastatic disease. The study is designed to compare patho...

This is a phase II , openlabel, randomized study in patients with confirmed diagnosis of potentially or borderline resectable metastatic colorectal adenocarcinoma (RAS and B-RAF WT tumors ), who have not received prior chemotherapy for their metastatic disease. The study is designed to compare pathological responses observed after pre-operative chemotherapy cetuximab with FOLFOX or FOLFIRI.

Inclusion Criterias

Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception.
Extra hepatic metastatic location is limited to 1 site.
Female or male patients with at least 18 years at the time the informed consent is signed
...
Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception.
Extra hepatic metastatic location is limited to 1 site.
Female or male patients with at least 18 years at the time the informed consent is signed
Partial and minor resection of metastatic disease is allowed within 3 months before inclusion if patient has never received chemotherapy for mCRC.
Life expectancy of at least 3 months without any active treatment.
Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception.
Patients with potentially resectable metastatic disease at diagnosis and for whom a chemotherapy first in a curative intent is recommended . Resectability could be planed in one or multiple stage if indicated. As commonly admitted, resectability means the surgical clearance (+/- radiofrequency ablation) of all detectable (liver) lesions with tumor-free margins and compatible with an adequate hepatic reserve. Practically, bilateral tumor location, number and location of lesions, and inadequate hepatic reserve remain the main decisional factors.
ECOG performance status 0 or 1
Patients may have received adjuvant chemotherapy or (neo-) adjuvant chemo-radiotherapy to the pelvis, provided the last dose of chemotherapy was administered at least 6 months prior to inclusion (12 months for oxaliplatin). Previous radiotherapy to the pelvis is not an exclusion criterion.
Histological or cytological confirmed diagnostic of adenocarcinoma of the colon or rectum, with or without primary tumour in situ. Wild-type RAS and B-RAF tumor status.

Exclusion Criterias

7.Prior major liver resection: remnant liver < 50% of the initial liver volume.
2.Prior chemotherapy or systemic therapy for mCRC. Adjuvant chemotherapy for colorectal cancer is not an exclusion criterion provided that it was completed more than 6 months prior to inclusion. Oxaliplatin-based chemotherapy must be completed more than 1 year prior to inclusion.
9.Concurrent central nervous systems metastases
...
7.Prior major liver resection: remnant liver < 50% of the initial liver volume.
2.Prior chemotherapy or systemic therapy for mCRC. Adjuvant chemotherapy for colorectal cancer is not an exclusion criterion provided that it was completed more than 6 months prior to inclusion. Oxaliplatin-based chemotherapy must be completed more than 1 year prior to inclusion.
9.Concurrent central nervous systems metastases
12.Pregnant or breast feeding.
10.Peripheric neuropathy ≥ grade 2.
8.Non-malignant disease that would render the patient unsuitable for treatment according to this protocol.
13.The patient has previous or concomitant malignancies, except: Invasive malignancies in remission for more than 5 years and non melanoma skin cancer or carcinoma in situ of the cervix.
1.Definitively non resectable mCRC at diagnosis
5 Non mesurable disease( RECIST 1.1 criteria)
3.Prior utilization of cetuximab, panitumumab (or other anti-EGFR (epidermal growth factor receptor)therapy).
11.Interstitial lung disease
4.Previous radiotherapy delivered to the upper abdomen.
6.Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment.

Locations

Brussels, 1200
Ottignies, 1340
Liège, 4000
Bouge, 5004
Yvoir, 5530
...
Brussels, 1200
Ottignies, 1340
Liège, 4000
Bouge, 5004
Yvoir, 5530
La Louvière, 7100
Charleroi, Hainaut, 6000

Tracking Information

NCT #
NCT01858662
Collaborators
Grand Hôpital de Charleroi
Investigators
  • Principal Investigator: Marc Van den Eynde, MD Cliniques universitaires Saint-Luc - UCL Principal Investigator: Javier Carrasco, MD PhD Grand Hôpital de Charleroi
  • Marc Van den Eynde, MD Cliniques universitaires Saint-Luc - UCL Principal Investigator: Javier Carrasco, MD PhD Grand Hôpital de Charleroi