Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma (Prodige20)
NCT ID: NCT01900717
Last Updated: 2018-12-27
Study Results
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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COMPLETED
PHASE2
102 participants
INTERVENTIONAL
2011-07-31
2016-03-31
Brief Summary
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This study is destined to continue as a phase III trial if both arms meet the selection criteria to show or not the benefits of treatment with bevacizumab combined with chemotherapy.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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chimiotherapy alone
* LV5FU2 simplified,
* 5-fluorouracil/leucovorin with oxaliplatin 4 (FOLFOX) simplified,
* fluorouracil, leucovorin, and irinotecan(FOLFIRI) modified.
LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified
chemiotherapy + bevacizumab 5 mg/kg/ 2 weeks
* LV5FU2 simplified,
* FOLFOX 4 simplified,
* FOLFIRI modified.
* Bevacizumab 5 mg/kg/ 2 weeks
LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks
Interventions
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LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified
LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks
Eligibility Criteria
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Inclusion Criteria
* ECOG ≤2
* histologically proven unresectable metastatic colorectal adenocarcinoma
* Measurable lesion according to RECIST criteria
* Absence of prior chemotherapy for metastatic disease. Adjuvant chemotherapy following resection of the primary tumor is authorized if completed more than 6 months previously
* Patients treated with anticoagulants (coumadin, warfarin) can be included if close surveillance of the INR can be ensured. A change to low-molecular-weight heparin is preferable as long as the indications are respected
* Completed geriatric self-questionnaire
* Completed "Team" geriatric questionnaire (including Spitzer QoL Index)
* Written informed consent
Exclusion Criteria
* Non-resolved intestinal occlusion or sub-occlusion
* Cerebral metastasis
* Other evolutive malignant tumor (non-stabilized cancer for less than 2 years)
* Evolutive gastroduodenal ulcer, wound or bone fracture
* Active heart disease: uncontrolled hypertension, myocardial infarction In the previous 6 months, angina, non-compensated congestive heart failure
* Major surgery, except for biopsy, or irradiation in the 4 weeks preceding the start of treatment
* Polynuclear neutrophils \<1500/mm3, platelets \<100 000/mm3 or 24-h proteinuria \> 1g
* History of arterial thromboembolic event (cerebrovascular accident, transient ischemic attack, subarachnoid hemorrhage) in the 12 months preceding the first dose of bevacizumab
* History of distal or visceral ischemia ≥ grade 2 in the 12 months preceding the first dose of bevacizumab
* History of life-threatening pulmonary embolism in the 6 months preceding the first dose of bevacizumab
* Impossibility to ensure regular follow-up
75 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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CHU de Dijon
Dijon, , France
Countries
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References
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Dohan A, Gallix B, Guiu B, Le Malicot K, Reinhold C, Soyer P, Bennouna J, Ghiringhelli F, Barbier E, Boige V, Taieb J, Bouche O, Francois E, Phelip JM, Borel C, Faroux R, Seitz JF, Jacquot S, Ben Abdelghani M, Khemissa-Akouz F, Genet D, Jouve JL, Rinaldi Y, Desseigne F, Texereau P, Suc E, Lepage C, Aparicio T, Hoeffel C; PRODIGE 9 Investigators and PRODIGE 20 Investigators. Early evaluation using a radiomic signature of unresectable hepatic metastases to predict outcome in patients with colorectal cancer treated with FOLFIRI and bevacizumab. Gut. 2020 Mar;69(3):531-539. doi: 10.1136/gutjnl-2018-316407. Epub 2019 May 17.
Other Identifiers
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2010-022080-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Bedenne PHRC K 2010.
Identifier Type: -
Identifier Source: org_study_id