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Trial record 67 of 978 for:    colon cancer AND resection

Study Comparing Pathological Responses Observed on Colorectal Cancer Metastases Resected After Preoperative Bevacizumab With FOLFOX or FOLFIRI. (BEV-ONCO2012)

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ClinicalTrials.gov Identifier: NCT01858649
Recruitment Status : Unknown
Verified April 2017 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
First Posted : May 21, 2013
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
Grand Hôpital de Charleroi
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Procedure: Metastases resection Drug: Bevacizumab Drug: 5 FU Drug: Oxaliplatin Drug: Irinotecan Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase 2 Study Comparing Pathological Responses on Colorectal Cancer Metastases After Preoperative Treatment Combining Bevacizumab With FOLFOX or FOLFIRI
Study Start Date : May 2013
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Folfox: oxaliplatin +leucovorin+ 5FU
FOLFOX (oxaliplatin +leucovorin+ 5FU) +bevacizumab+ metastases resection
Procedure: Metastases resection
Surgery of colorectal cancer metastases will be proceeded after 3 to 6 cycles of chemotherapy ( folfox or folfiri) + bevacizumab .

Drug: Bevacizumab
Bevacizumab 5 mg/kg in 100 ml NaCl 0.9% IV infusion 3 to 5 cycles. No bevacizumab for ultimate cycle .
Other Name: Avastin

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
Other Name: 5-Fluorouracile

Drug: Oxaliplatin
oxaliplatin 85 mg/m² in 150 ml NaCl 0.9%, IV infusion 3 to 6 cycles
Other Name: Eloxatin

Active Comparator: FOLFIRI: irinotecan+leucovorin+5FU
FOLFIRI (irinotecan+leucovorin+5FU) +bevacizumab +metastases resection
Procedure: Metastases resection
Surgery of colorectal cancer metastases will be proceeded after 3 to 6 cycles of chemotherapy ( folfox or folfiri) + bevacizumab .

Drug: Bevacizumab
Bevacizumab 5 mg/kg in 100 ml NaCl 0.9% IV infusion 3 to 5 cycles. No bevacizumab for ultimate cycle .
Other Name: Avastin

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
Other Name: 5-Fluorouracile

Drug: Irinotecan
Irinotecan 180 mg/m² in 150 ml NaCl 0.9%, IV infusion 3 to 6 cycles
Other Names:
  • Campto
  • Irinosin




Primary Outcome Measures :
  1. the major pathological response rate [ Time Frame: After surgery (Metastases resection-average 3 months) ]
    This is at the surgery time. The metastases resection must be process after 6 cycles of randomized chemotherapy + target therapy. It depend but it will be normally 3 months after patient inclusion in the study


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: at 6 months and at 12 months after randomization ]
  2. Overall Survival [ Time Frame: At the end of the study ]
    The overall survival will be analyzed at the end of the study (3 years of recruitment and one years of follow-up)

  3. Clinical Response Rate [ Time Frame: At time of surgery - average 3 months ]
  4. Metabolic Response Rate [ Time Frame: At time of surgery - Average 3 months ]
  5. Post operative complication [ Time Frame: One month after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858649


Contacts
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Contact: Van den Eynde Marc, MD 00322764 ext 1041 marcvandeneynde@uclouvain.be
Contact: Carrasco Javier, MD PhD 00327110 ext 4701 javier.carrasco@ghdc.be

Locations
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Belgium
Clinique Saint Luc Recruiting
Bouge, Belgium, 5004
Contact: Laurence Jacqmin       laurence.jacqmin@slbo.be   
CHIREC Recruiting
Brussels, Belgium, 1180
Contact: sandrine roland, MD    02.434.46.64    roland_sandrine@yahoo.fr   
Contact: eugene mucyo    02.434.46.64    datamanagercci@skynet.be   
Cliniques universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Marc Van den Eynde, MD    0032764 ext 1041    marc.vandeneynde@uclouvain.be   
Principal Investigator: Marc Van den Eynde, MD         
Grand Hopital de Charleroi Recruiting
Charleroi, Belgium, 6000
Contact: Javier Carrasco, MD PhD    00327110 ext 4701    javier.carrasco@ghdc.be   
Principal Investigator: Javier Carrasco, MD PhD         
AZ Groeninge Recruiting
Kortrijk, Belgium, 8500
Contact: philippe vergauwe, MD       philippe.vergauwe@azgroeninge.be   
Contact: Fien Verplancke    056 63 33 38    fien.verplancke@azgroeninge.be   
Centre Hospitalier Jolimont Lobbes Recruiting
La Louvière, Belgium, 7100
Contact: Benedicte Petit, MD    +32.64.23.39.87    benedicte.petit@entitejolimontoise.be   
Principal Investigator: Benedicte Petit, MD         
CHC Liège clinique Saint Joseph Recruiting
Liège, Belgium, 4000
Contact: Gauthier Demolin, MD    +32.4.224.89.92    gauthier.demolin@chc.be   
Principal Investigator: Gauthier Demolin, MD         
CHU liège (Sart Timan) Recruiting
Liège, Belgium, 4000
Contact: Daniel Van Daele, MD    +32.04.242.55.21    daniel.vandaele@chu.ulg.ac.be   
Principal Investigator: Daniel Van Daele, MD         
Clinique Maternité Saint Elisabeth Recruiting
Namur, Belgium, 5000
Contact: Jean-Charles Goeminne, MD    +32.81.720.761    jeancharles.goeminne@cmsenamur.be   
Principal Investigator: Jean-Charles Goeminne, MD         
Clinique Saint Pierre Ottignies Recruiting
Ottignies, Belgium, 1340
Contact: Jean-Charles Coche, MD    +32.10.437.479    jc.coche@skynet.be   
Principal Investigator: Jean-Charles Coche, MD         
CHU-UCL Dinant-Godinne Recruiting
Yvoir, Belgium, 5530
Contact: Lionel D'hondt, MD PhD    +32.81.42.38.53    lionel.dhondt@uclouvain.be   
Principal Investigator: Lionel D'Hondt, MD PhD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Grand Hôpital de Charleroi
Investigators
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Principal Investigator: Marc Van den Eynde, MD Cliniques universitaires Saint-Luc
Principal Investigator: Javier Carrasco, MD PhD Grand Hôpital de Charleroi - Notre-Dame

Publications:

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01858649     History of Changes
Other Study ID Numbers: BEV-ONCO2012
2012-005376-34 ( EudraCT Number )
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: April 2017

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
metastatic
colorectal
cancer
liver
Bevacizumab
Pathological response

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Oxaliplatin
Irinotecan
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action