Status:
TERMINATED
Study Comparing Pathological Responses Observed on Colorectal Cancer Metastases Resected After Preoperative Treatment Combining Cetuximab With FOLFOX or FOLFIRI in RAS and B-RAF WT Tumors
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborating Sponsors:
Grand Hôpital de Charleroi
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To analyze the pathological tumor response on resected colorectal cancer metastases after preoperative treatment with cetuximab combined with FOLFOX or FOLFIRI regimen in a prospective cohort (RAS and...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Female or male patients with at least 18 years at the time the informed consent is signed
- ECOG performance status 0 or 1
- 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.
- 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.
- Partial and minor resection of metastatic disease is allowed within 3 months before inclusion if patient has never received chemotherapy for mCRC.
- Extra hepatic metastatic location is limited to 1 site.
- 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.
- Adequate haematological, renal and hepatic function as follows:
- Haematological:
- haemoglobin \>9g/dl Neutrophils \> 1.5 x 109/L Platelets \> 100 x 109/L
- Renal:
- Creatinine\< 1.5 x ULN (Upper Limit of Normal)
- Hepatic:
- Bilirubin \< or equal 1.5 X ULN AST (Aspartate Aminotransferase),and ALT (Alanine Aminotransferase)\< or equal 5 x ULN, Phos Alc\< or equal 5 x ULN
- Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception.
- Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception.
- Life expectancy of at least 3 months without any active treatment.
Exclusion
- Definitively non resectable mCRC at diagnosis
- 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.
- Prior utilization of cetuximab, panitumumab (or other anti-EGFR (epidermal growth factor receptor)therapy).
- Previous radiotherapy delivered to the upper abdomen.
- 5 Non mesurable disease( RECIST 1.1 criteria)
- Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment.
- Prior major liver resection: remnant liver \< 50% of the initial liver volume.
- Non-malignant disease that would render the patient unsuitable for treatment according to this protocol.
- Concurrent central nervous systems metastases
- Peripheric neuropathy ≥ grade 2.
- Interstitial lung disease
- Pregnant or breast feeding.
- 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.
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01858662
Start Date
January 1 2014
End Date
November 1 2015
Last Update
April 15 2016
Active Locations (7)
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1
Cliniques universitaires Saint-Luc - UCL
Brussels, Brussels Capital, Belgium, 1200
2
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium, 6000
3
clinique Saint Luc
Bouge, Belgium, 5004
4
Centre Hospitalier Jolimont Lobbes
La Louvière, Belgium, 7100