Study Comparing Pathological Responses Observed on Colorectal Cancer Metastases Resected After Preoperative Bevacizumab With FOLFOX or FOLFIRI.
NCT ID: NCT01858649
Last Updated: 2020-10-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-05-31
Study Completion Date
2019-05-31
Brief Summary
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The study is designed to analyze the pathological tumor response on resected colorectal cancer metastases after preoperative treatment with bevacizumab combined with FOLFOX or FOLFIRI regimen in a prospective cohort and to correlate this response with patient's outcome.
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Detailed Description
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This is a phase II , openlabel, randomized study in patients with confirmed diagnosis of resectable metastatic colorectal adenocarcinoma , who have not received prior chemotherapy for their metastatic disease. The study is designed to compare pathological responses observed after pre-operative chemotherapy bevacizumab with FOLFOX or FOLFIRI.
Conditions
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Metastatic Colorectal Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Folfox: oxaliplatin +leucovorin+ 5FU
FOLFOX (oxaliplatin +leucovorin+ 5FU) +bevacizumab+ metastases resection
Group Type
ACTIVE_COMPARATOR
Metastases resection
Intervention Type
PROCEDURE
Surgery of colorectal cancer metastases will be proceeded after 3 to 6 cycles of chemotherapy ( folfox or folfiri) + bevacizumab .
Bevacizumab
Intervention Type
DRUG
Bevacizumab 5 mg/kg in 100 ml NaCl 0.9% IV infusion 3 to 5 cycles. No bevacizumab for ultimate cycle .
5 FU
Intervention Type
DRUG
Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, IV infusion 3 to 6 cycles 5-FU bolus 400 mg/m2, IV bolus 3 to 6 cycles 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion 3 to 6 cycles
Oxaliplatin
Intervention Type
DRUG
oxaliplatin 85 mg/m² in 150 ml NaCl 0.9%, IV infusion 3 to 6 cycles
FOLFIRI: irinotecan+leucovorin+5FU
FOLFIRI (irinotecan+leucovorin+5FU) +bevacizumab +metastases resection
Group Type
ACTIVE_COMPARATOR
Metastases resection
Intervention Type
PROCEDURE
Surgery of colorectal cancer metastases will be proceeded after 3 to 6 cycles of chemotherapy ( folfox or folfiri) + bevacizumab .
Bevacizumab
Intervention Type
DRUG
Bevacizumab 5 mg/kg in 100 ml NaCl 0.9% IV infusion 3 to 5 cycles. No bevacizumab for ultimate cycle .
5 FU
Intervention Type
DRUG
Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, IV infusion 3 to 6 cycles 5-FU bolus 400 mg/m2, IV bolus 3 to 6 cycles 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion 3 to 6 cycles
Irinotecan
Intervention Type
DRUG
Irinotecan 180 mg/m² in 150 ml NaCl 0.9%, IV infusion 3 to 6 cycles
Interventions
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Metastases resection
Surgery of colorectal cancer metastases will be proceeded after 3 to 6 cycles of chemotherapy ( folfox or folfiri) + bevacizumab .
Intervention Type
PROCEDURE
Bevacizumab
Bevacizumab 5 mg/kg in 100 ml NaCl 0.9% IV infusion 3 to 5 cycles. No bevacizumab for ultimate cycle .
Intervention Type
DRUG
5 FU
Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, IV infusion 3 to 6 cycles 5-FU bolus 400 mg/m2, IV bolus 3 to 6 cycles 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion 3 to 6 cycles
Intervention Type
DRUG
Oxaliplatin
oxaliplatin 85 mg/m² in 150 ml NaCl 0.9%, IV infusion 3 to 6 cycles
Intervention Type
DRUG
Irinotecan
Irinotecan 180 mg/m² in 150 ml NaCl 0.9%, IV infusion 3 to 6 cycles
Intervention Type
DRUG
Other Intervention Names
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Avastin
5-Fluorouracile
Eloxatin
Campto
Irinosin
Eligibility Criteria
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Inclusion Criteria
* 1\. Female or male patients with at least 18 years at the time the informed consent is signed
* 2.ECOG (Eastern Cooperative Oncology Group)performance status 0 or 1
* 3.Histological or cytological confirmed diagnostic of adenocarcinoma of the colon or rectum, with or without primary tumour in situ. Wild-type or mutated KRAS tumor status.
* 4.Patients must present a resectable metastatic disease for which the decision of preoperative chemotherapy is considered. Resectability could be planned 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.
* 5.Partial and minor resection of metastatic disease is allowed within 3 months before inclusion if patient has never received chemotherapy for mCRC.
* 6.Extra hepatic metastatic location is limited to 1 site. Extra-hepatic location must be easily resectable in one stage surgery.
* 7.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.
* 8.Adequate haematological, renal and hepatic function as follows: Haematological Neutrophils \> 1.5 x 109/L Platelets \> 100 x 109/L Renal Creatinine \< 1.5 x ULN (Upper Limit of Normal) Hepatic Bilirubin \< 1.5 X ULN AST(Aspartate aminotransferase), ALT (Alanine Aminotransferase) \< 5 x ULN Phos Alc. \< 5 x ULN
* 9.Proteinuria \<2+ (dipstick urinalysis) or =1g/24hour.
* 10.No history of myocardial infarction and/or stroke within 6 months prior to randomization. No uncontrolled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy.
* 11.Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception.
* 12.Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception.
* 13.Life expectancy of at least 3 months without any active treatment.
* 2.ECOG (Eastern Cooperative Oncology Group)performance status 0 or 1
* 3.Histological or cytological confirmed diagnostic of adenocarcinoma of the colon or rectum, with or without primary tumour in situ. Wild-type or mutated KRAS tumor status.
* 4.Patients must present a resectable metastatic disease for which the decision of preoperative chemotherapy is considered. Resectability could be planned 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.
* 5.Partial and minor resection of metastatic disease is allowed within 3 months before inclusion if patient has never received chemotherapy for mCRC.
* 6.Extra hepatic metastatic location is limited to 1 site. Extra-hepatic location must be easily resectable in one stage surgery.
* 7.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.
* 8.Adequate haematological, renal and hepatic function as follows: Haematological Neutrophils \> 1.5 x 109/L Platelets \> 100 x 109/L Renal Creatinine \< 1.5 x ULN (Upper Limit of Normal) Hepatic Bilirubin \< 1.5 X ULN AST(Aspartate aminotransferase), ALT (Alanine Aminotransferase) \< 5 x ULN Phos Alc. \< 5 x ULN
* 9.Proteinuria \<2+ (dipstick urinalysis) or =1g/24hour.
* 10.No history of myocardial infarction and/or stroke within 6 months prior to randomization. No uncontrolled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy.
* 11.Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception.
* 12.Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception.
* 13.Life expectancy of at least 3 months without any active treatment.
Exclusion Criteria
* 1.Non resectable mCRC (metastatic ColoRectal Cancer) (if resectability remains uncertain or unprobable after 3 months chemotherapy, patient is excluded from the trial).
* 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.
* 3.Prior utilization of bevacizumab, aflibercept (or other anti-VEGF(vascular endothelial growth factor) therapy).
* 4.Previous radiotherapy delivered to the upper abdomen.
* 5.Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment.
* 6.Prior major liver resection: remnant liver \< 50% of the initial liver volume.
* 7.Non-malignant disease that would render the patient unsuitable for treatment according to this protocol.
* 8.Concurrent central nervous systems metastases
* 9.Peripheric neuropathy ≥ grade 2.
* 10.Interstitial lung disease
* 11.Pregnant or breast feeding.
* 12.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.
* 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.
* 3.Prior utilization of bevacizumab, aflibercept (or other anti-VEGF(vascular endothelial growth factor) therapy).
* 4.Previous radiotherapy delivered to the upper abdomen.
* 5.Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment.
* 6.Prior major liver resection: remnant liver \< 50% of the initial liver volume.
* 7.Non-malignant disease that would render the patient unsuitable for treatment according to this protocol.
* 8.Concurrent central nervous systems metastases
* 9.Peripheric neuropathy ≥ grade 2.
* 10.Interstitial lung disease
* 11.Pregnant or breast feeding.
* 12.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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Grand Hôpital de Charleroi
OTHER
Sponsor Role
collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Marc Van den Eynde, MD
Role: PRINCIPAL_INVESTIGATOR
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Javier Carrasco, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Grand Hôpital de Charleroi - Notre-Dame
Locations
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Clinique Saint Luc
Bouge, , Belgium
Site Status
CHIREC
Brussels, , Belgium
Site Status
Cliniques universitaires Saint-Luc
Brussels, , Belgium
Site Status
Grand Hopital de Charleroi
Charleroi, , Belgium
Site Status
AZ Groeninge
Kortrijk, , Belgium
Site Status
Centre Hospitalier Jolimont Lobbes
La Louvière, , Belgium
Site Status
CHC Liège clinique Saint Joseph
Liège, , Belgium
Site Status
CHU liège (Sart Timan)
Liège, , Belgium
Site Status
Clinique Maternité Saint Elisabeth
Namur, , Belgium
Site Status
Clinique Saint Pierre Ottignies
Ottignies, , Belgium
Site Status
CHU-UCL Dinant-Godinne
Yvoir, , Belgium
Site Status
Countries
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Belgium
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-005376-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BEV-ONCO2012
Identifier Type: -
Identifier Source: org_study_id
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