Aflibercept +/- LV5FU2 in First Line of Non-resectalbe Metastatic Colorectal Cancers
FOLFA
Phase II Randomized Trial Evaluting Aflibercept Associated With LV5FU2 Regimen as First Line Treatment of Non-resectalbe Metastatic Colorectal Cancers
1 other identifier
interventional
117
1 country
58
Brief Summary
This is what the FFCD 11-01 - PRODIGE 25 trial proposes to study, as a preliminary for strategic studies evaluating the usefulness of including targeted therapeutics from the first line with aflibercept +/- LV5FU2.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2015
Longer than P75 for phase_2
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2015
CompletedFirst Posted
Study publicly available on registry
March 10, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedResults Posted
Study results publicly available
July 10, 2024
CompletedJuly 10, 2024
July 1, 2024
6.1 years
January 28, 2015
December 21, 2022
July 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Primary Objective Was the Percentage of Patients Alive and Without Progression 6 Months After the Randomization.
Progression was assessed by the investigator according to RECIST 1.1 criteria based on imaging studies performed every 8 weeks, even in case of deferred treatments. Clinical progressions, not confirmed on imaging, were not be counted in the primary endpoint
At 6 months after randomization
Secondary Outcomes (2)
Overall Survival (OS)
Up to 3 years after the treatment start
Progression-free Survival (PPFS)
up to 12 months after randomization
Study Arms (2)
A
EXPERIMENTALAflibercept + LV5FU2
B
ACTIVE COMPARATORLV5FU2
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 65 years
- General condition WHO ≤ 2
- Metastatic rectal or colonic adenocarcinoma, histologically proved on the primary tumour or a metastasis
- Metastases non-resectable and/or patient inoperable
- patients where a single agent chemotherapy combined with an anti-angiogenic agent is an appropriate approach
- At least one measurable target according to RECIST v1.1 criteria, no previously irradiated
- No previous treatment of the metastatic disease. Previous chemotherapy in an adjuvant situation completed 6 months or more before diagnosis of the metastasis is authorized.
- Adequate biological examination: Hb \> or = 9 g/dl, polynuclear neutrophils \> or = 1,500/mm3, platelets \> or =100,000/mm3, total bilirubin \< or = 1.5 x UNL, creatinine clearance, calculated according to Cockroft-Gault formula, \> 50 ml/min creatininemia \< 1.5 x UNL, ALP \< 5 x UNL, transaminases \< 5 x ULN, GGT\< 5 x UNL
- Proteinuria (strip) \< 2+; if \> or = 2+, test proteinuria over 24 hours which must be ≤ 1 g.
- Central genotyping of thymidylate synthase (TS) in blood DNA
- Patients treated with anticoagulants (coumadin, warfarin) can be included if the INR can be closely monitored. A change in anticoagulant treatment for low molecular weight heparin is preferable in order to respect indications
You may not qualify if:
- Patients with a primary tumour in place and presenting clinical symptoms (occlusion, haemorrhage)
- History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
- Uncontrolled hypercalcemia
- Uncontrolled hypertension (SBP \> 150 mmHg and DBP \> 100 mmHg) or history of hypertensive attacks or hypertensive encephalopathy
- Any progressive pathology not balanced over the past 6 months: hepatic insufficiency, renal insufficiency, respiratory insufficiency,
- Major surgery during the 28 days preceding the start of treatment
- Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
- Treatment with concomitant anticonvulsivant agents that are CYP3A4 inducers (phenytoin, phenobarbital, carbamazepine), unless discontinued \>7 days.
- Anti-tumoral treatments other than the trial treatments (chemotherapy, targeted therapy, immunotherapy)
- Macronodular peritoneal carcinosis (risk of perforation)
- Known DPD deficit
- Prior history of malignant haemopathy or cancer except those treated more than 5 years ago and considered to be cured, in situ cervical carcinomas and treated skin cancers (excluding melanoma)
- Patients on new oral anticoagulant therapy (rivaroxaban XARELTOR, apixaban ELIQUIS, dagigatran PRADAXA except if relay by vitamine K antagonist therapy)
- Any contraindication to the treatments used in the trial
- Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
CH
Aix-en-Provence, France
CHU Amiens - Hôpital Nord
Amiens, 80054, France
Chu D'Angers
Angers, 49933, France
ICO
Angers, France
CH
Auxerre, France
CH de la Côte Basque
Bayonne, 64109, France
Centre D'Oncologie Et de Radiothérapie
Bayonne, France
CH
Béziers, France
Hôpital Avicenne
Bobigny, 93000, France
CHU APHP Hôpital Avicenne
Bobigny, France
CHU- Hôpital Saint André
Bordeaux, France
Polyclinique Bordeaux Nord
Bordeaux, France
CH - Hôpital Duchenne
Boulogne-sur-Mer, France
CH
Brive-la-Gaillarde, France
CHU Côte de Nacre
Caen, France
Ch
Chambéry, France
CH Public du Cotentin
Cherbourg, France
CHU Estaing
Clermont-Ferrand, France
CH Alpes Leman
Contamine-sur-Arve, France
Centre hospitalier Sud Francilien
Corbeil-Essonnes, 91106, France
Institut de cancérologie de Bourgogne - GRRECC
Dijon, 21000, France
CHU Le Bocage
Dijon, France
CH
Elbeuf, France
Chicas
Gap, France
CHD Vendée
La Roche-sur-Yon, France
CH Robert Boulin
Libourne, France
Clinique François Chénieux
Limoges, 87000, France
CHU
Limoges, France
Ch Longjumeau
Longjumeau, 91160, France
CH Hôpital du Surcoff
Lorient, France
Ch Saint Joseph - Saint Luc
Lyon, France
CHU APHM Hôpital Nord
Marseille, France
CHU APHM La Timone
Marseille, France
Hôpital Européen de Marseille
Marseille, France
CH
Meaux, France
CH
Montélimar, France
CHU - Hôtel Dieu
Nantes, France
Polyclinique de Languedoc
Narbonne, France
CHR La Source
Orléans, 45067, France
Saint-Louis CHU AP-HP Paris
Paris, 75010, France
CH
Perpignan, France
Hôpital Haut Leveque
Pessac, 33604, France
CHU Hôpital de la Milétrie
Poitiers, France
Centre Hospitalier Annecy Genevois
Pringy, France
Centre Eugène Marquis
Rennes, France
CHU
Rouen, France
CARIO - Hôpital Privé des Côte d'Armor
Saint-Brieuc, France
ICO
Saint-Herblain, France
Polyclinique Côte Basque Sud
Saint-Jean-de-Luz, France
Ch Saintonges
Saintes, France
Centre de cancérologie Paris Nord
Sarcelles, France
CH de Bigorre
Tarbes, France
Hôpitaux du Leman
Thonon-les-Bains, France
CHU Hôpital Rangueil
Toulouse, France
Hôpital Trousseau
Tours, France
CHBA
Vannes, France
Institut Gustave Roussy
Villejuif, France
Hôpital Privé de Villeneuve d'Ascq
Villeneuve-d'Ascq, France
Related Publications (1)
Legoux JL, Faroux R, Barriere N, Le Malicot K, Tougeron D, Lorgis V, Guerin-Meyer V, Bourgeois V, Malka D, Aparicio T, Baconnier M, Lebrun-Ly V, Egreteau J, Khemissa Akouz F, Terme M, Lepage C, Boige V. First-Line LV5FU2 with or without Aflibercept in Patients with Non-Resectable Metastatic Colorectal Cancer: A Randomized Phase II Trial (PRODIGE 25-FFCD-FOLFA). Cancers (Basel). 2024 Apr 16;16(8):1515. doi: 10.3390/cancers16081515.
PMID: 38672597RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Karine Le Malicot
- Organization
- Fédération Francophone de Cancérologie Digestive
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Louis LEGOUX, MD
ORLEANS - Centre Hospitalier La Source
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2015
First Posted
March 10, 2015
Study Start
May 1, 2015
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
July 10, 2024
Results First Posted
July 10, 2024
Record last verified: 2024-07