An Observational Study on Bevacizumab (Avastin) as First-Line Treatment in Colorectal Cancer Participants With Potentially Resectable Liver Metastases
PICASSO
A Cohort Study of Patients With Metastatic Colorectal Cancer Treated With Avastin® as First-line Therapy for Liver Metastases Considered as Potentially Resectable
1 other identifier
observational
210
1 country
126
Brief Summary
This observational study will evaluate the efficacy and safety of bevacizumab as first-line treatment in participants with colorectal cancer and potentially resectable liver metastases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Longer than P75 for all trials
126 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
Study Start
First participant enrolled
September 30, 2010
CompletedFirst Submitted
Initial submission to the registry
April 27, 2011
CompletedFirst Posted
Study publicly available on registry
April 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2015
CompletedResults Posted
Study results publicly available
April 25, 2017
CompletedApril 25, 2017
March 1, 2017
4.8 years
April 27, 2011
March 15, 2017
March 15, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery
Secondary resection involves removal of all detectable metastases at surgery including participants with missing metastases left in place. Percentage of participants without detectable metastatic disease after secondary resection removing all detectable metastases at surgery (including participants with disappeared metastases left in place \[missing metastases\]) was reported. Metastases was detected using computed tomography (CT) scan or magnetic resonance imaging (MRI).
Baseline up to 36 months
Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery
The percentage of participants with no detectable metastatic disease after a complete response without surgery (missing metastasis) was reported.
Baseline up to 36 months
Secondary Outcomes (16)
Percentage of Participants With at Least One Disease and Comorbidity at Day 0
Day 0
Percentage of Participants With Different Previous Therapies at Day 0
Day 0
Mean Number of Cumulated Cycles of Bevacizumab Over the Study Period
Baseline up to 36 months
Percentage of Participants Who Received at Least One Chemotherapy Over the Study Period
Baseline up to 36 months
Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment
Baseline up to 36 months
- +11 more secondary outcomes
Study Arms (1)
Bevacizumab
Participants with metastatic colorectal cancer (mCRC) with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases will be observed.
Interventions
Participants with mCRC and having exclusively liver or liver and lung metastases who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion will be observed. All concomitant medications as used in routine clinical practice are allowed.
Eligibility Criteria
Participants with colorectal cancer and hepatic or hepatic and pulmonary metastases
You may qualify if:
- Participants with colorectal cancer with exclusively hepatic or hepatic and pulmonary metastases
- First-line treatment with bevacizumab for potentially resectable metastatic disease
You may not qualify if:
- Outright resectable disease
- Clearly inoperable disease
- Participation in a clinical trial evaluating a cytotoxic anticancer treatment and/or an innovative therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (126)
Clinique Esquirol Saint Hilaire
Agen, 47002, France
C.H. Du Pays D'aix En Provence Service du Dr Blanc
Aix-en-Provence, 13616, France
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
Aix-en-Provence, 13617, France
Chi D Alencon; Medecine Ambulatoire
Alençon, 61014, France
Ch D Ales; Oncologie
Alès, 30103, France
Hopital Nord; Medecine A
Amiens, 80054, France
Clinique De L Europe; Pmsi
Amiens, 80090, France
Clinique De L Europe; Radiotherapie Chimiotherapie
Amiens, 80090, France
Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero
Amilly, 45200, France
Hotel Dieu; Medecine A
Angers, 49093, France
Centre Radiotherapie Marie Curie
Arras, 62000, France
HOP Prive Arras Les Bonnettes; Chimiotherapie
Arras, 62012, France
Polyclinique Sainte Marguerite; Chimiotherapie
Auxerre, 89000, France
Chic Cote Basque Bayonne; Medecine II
Bayonne, 64109, France
Clinique Saint Etienne; Medecine
Bayonne, 64115, France
Centre Hospitalier; Hematologie-Oncologie
Beauvais, 60021, France
Ch de Belfort; Hopital de Jour
Belfort, 90016, France
Hopital Jean Minjoz; Gastro Enterologie
Besançon, 25030, France
HOPITAL JEAN MINJOZ; Oncologie
Besançon, 25030, France
Centre Pierre Curie
Beuvry, 62660, France
Centre De Radiotherapie Oncodoc
Béziers, 34500, France
Clinique Champeau Mediterranee; Radiotherapie Oncologie
Béziers, 34535, France
Clinique Tivoli; Sce Radiotherapie
Bordeaux, 33000, France
Fondation Bergonie; Gastro-Enterologie
Bordeaux, 33076, France
Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie
Bordeaux, 33077, France
Clinique Du Docteur Convert; Medecine
Bourg-en-Bresse, 01004, France
Centre Hospitalier Fleyriat; Oncologie/Hematologie
Bourg-en-Bresse, 01012, France
Ch De Fleyriat; Gastro Enterologie
Bourg-en-Bresse, 01012, France
Ch Pierre Oudot; Gastro Enterologie
Bourgoin, 38317, France
Ch Jean Rougier; Oncologie Gastro Enterologie
Cahors, 46005, France
Infirmerie Protestante; Endos Digestive Coelioscopie
Caluire-et-Cuire, 69300, France
Ch Antoine Gayraud; Oncologie
Carcassonne, 11890, France
Cabinet Medical
Challes-les-Eaux, 73190, France
Ch de Chambery; Gastro Enterologie
Chambéry, 73011, France
Hopital Manchester; Gastro Enterologie
Charleville-Mézières, 08011, France
CH Du Cotentin Site De Cherbourg; Hopital De Jour
Cherbourg Octeville, 50102, France
Clinique Des Cedres; Medecine 2
Cornebarrieu, 31700, France
CHU Henri Mondor; Service d'Oncologie Medicale
Créteil, 94010, France
Ch De Dax; Radiotherapie Oncologie
Dax, 40107, France
Centre Leonard De Vinci;Chimiotherapie
Dechy, 59187, France
Cabinet
Dijon, 21000, France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, 21079, France
Ch De La Dracenie; Hopital De Jour
Draguignan, 83007, France
Hopital Victor Jousselin; Gastro Enterologie
Druex, 28102, France
Hopital Simone Veil Eaubonne; Hopital De Jour
Eaubonne, 95602, France
Clinique Pasteur; Oncologie Medicale, Hematologie
Évreux, 27025, France
Ch Jacques Monod;Medecine A4 B4
Flers, 61104, France
Hopital De Freyming; Secteur 1
Freyming-Merlebach, 57804, France
Centre Gastro Loire
Gien, 45 500, France
Hopital Nord Ouest;Gastro Enterologie
Gleizé, 69400, France
Hopital Alpha Sante De Hayange; Medecine B
Hayange, 57701, France
Clinique de L' Esperance; Oncologie
Hyères, 83400, France
Clinique Sainte Marguerite; Oncologie Medicale
Hyères, 83400, France
Polyclinique de Blois; Chimiotherapie Ambulatoire
La Chaussée-Saint-Victor, 41260, France
CH Dptal Les Oudairies; Gastro Enterologie
La Roche-sur-Yon, 85925, France
CH Dptal Les Oudairies; Hematologie Oncologie
La Roche-sur-Yon, 85925, France
Hopital Albert Michallon; Gastro Enterologie
La Tronche, 38700, France
Hopital Albert Michallon; Radiotherapie
La Tronche, 38700, France
Hopital Robert Boulin; Oncologie
Libourne, 33505, France
Cabinet Medical
Lille, 59800, France
Clinique Chenieux; Oncology
Limoges, 87039, France
Ch De Longjumeau; Hopital De Jour Et Semaine
Longjumeau, 91161, France
CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie
Lorient, 56322, France
Clinique Des 4 Pavillons; Chimiotherapie
Lormont, 33310, France
Hia Desgenettes; Oncologie Hematologie
Lyon, 69275, France
Hopital De La Croix Rousse;Hepato Gastro Entero
Lyon, 69317, France
Clinique De La Sauvegarde; Chimiotherapie
Lyon, 69337, France
Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie
Lyon, 69365, France
Hopital Prive Jean Mermoz; Cancerologie
Lyon, 69373, France
Clinique Saint Faron; Sce Oncologie Radiotherapie
Mareuil-lès-Meaux, 77100, France
Fondation Hopital Saint Joseph; Gastro-Enterologie
Marseille, 13285, France
Ch De Meaux; Gastro Enterologie
Meaux, 77104, France
Hopital Clinique Claude Bernard; Oncologie Medicale
Metz, 57000, France
Chra; Gastro Enterologie
Metz-Tessy, 74370, France
Hopital Layne; Medecine Ambulatoire
Mont-de-Marsan, 40024, France
Site Le Mittan; Hopital De Jour
Montbéliard, 25209, France
Ch De Montelimar; Gastro Enterologie Oncologie
Montélimar, 26216, France
Ghi Le Raincy Montfermeil; Gastro Medecine Interne
Montfermeil, 93370, France
Ghi Le Raincy Montfermeil; Radiotherapie Oncologie
Montfermeil, 93370, France
Ctre Radiotherapie Joseph Belot; Hematologie
Montluçon, 03100, France
Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie
Montpellier, 34967, France
Centre Azureen De Cancerologie; Cons externes
Mougins, 06250, France
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
Nancy, 54100, France
Polyclinique Du Languedoc; Chimiotherapie
Narbonne, 11780, France
Ch De Nemours; Medecine 1
Nemours, 77796, France
Clinique Du Parc Imperial; Chimiotherapie
Nice, 06000, France
Hopital De L Archet;Gastro Nutrition Oncologie
Nice, 06202, France
Hopital Caremeau; Gastro Enterologie
Nîmes, 30029, France
Hopital Des Diaconesses; Hopital De Jour
Paris, 75571, France
Ch Pitie Salpetriere; Oncologie Medicale
Paris, 75651, France
GH Paris Saint Joseph; Hopital De Jour Oncologie
Paris, 75674, France
Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie
Paris, 75877, France
HOPITAL TENON; Cancerologie Medicale
Paris, 75970, France
Centre Catalan D' Oncologie
Perpignan, 66000, France
Hopital Saint Jean; Centre Henri Pujol
Perpignan, 66046, France
Hopital Du Haut-Leveque; Gastro-Enterologie
Pessac, 33604, France
Clinique Francheville; Radiotherapie
Périgueux, 24000, France
Ch De Perigueux; Had Perigueux
Périgueux, 24019, France
Ch Lyon Sud; Gastro Secteur Jules Courmont
Pierre-Bénite, 69495, France
Clinique Armoricaine Radiologie; Hopital de Jour
Plérin, 22190, France
Chu La Miletrie; Gastro Enterologie Endoscopies
Poitiers, 86021, France
Hopital Rene Dubos; Service de Medecine Generale & de Gastro-Enterologie
Pontoise, 95300, France
Centre Eugene Marquis; Unite Huguenin
Rennes, 35042, France
Hopital Charles Nicolle; Endoscopies Digestives
Rouen, 76031, France
Clinique De L Europe; Chimiotherapie
Rouen, 76040, France
Clinique Saint Hilaire; Sce Chimiotherapie
Rouen, 76044, France
Hopital Yves Le Foll; Hepatologie Gastro Enterologie
Saint-Brieuc, 22027, France
Chi Poissy Saint Germain En Laye; Centre Coordination Cancerologie
Saint-Germain-en-Laye, 78105, France
Chp Saint Gregoire; Cancerologie Radiotherapie
Saint-Grégoire, 35768, France
Ico Rene Gauducheau; Oncologie
Saint-Herblain, 44805, France
Clinique de L'Union; Oncologie
Saint-Jean, 31240, France
Memorial France Etats Unis; Hopital De Jour
Saint-Lô, 50009, France
CMCO De La Cote D Opale; Auberge De Jour
Saint-Martin-Boulogne, 62280, France
Cabinet Medical
Saint-Priest, 69800, France
Centre Hospitalier General; Oncologie Medicale
Salouël, 80480, France
Clinique Chir De L Orangerie; Chimiotherapie
Strasbourg, 67010, France
Clinique Saint Anne; Hopital De Jour
Strasbourg, 67010, France
Centre Paul Strauss; Oncologie Medicale
Strasbourg, 67065, France
Clinique Sainte Anne; Hospitalisation
Strasbourg, 67085, France
Hopital Font Pre; Hemato-Oncologie
Toulon, 83056, France
Hopital Purpan; Chir Generale Digestive
Toulouse, 31059, France
Clinique Pasteur; Oncologie Medicale
Toulouse, 31076, France
Hopital Saint Nicolas; Medecine A
Verdun, 55107, France
Hopital Jacques Lacarin; Hopital De Jour
Vichy, 3201, France
Hopital Paul Brousse; Hematologie
Villejuif, 94804, France
Chi De Villeneuve St Georges; Oncologie
Villeneuve-Saint-Georges, 94195, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2011
First Posted
April 28, 2011
Study Start
September 30, 2010
Primary Completion
June 30, 2015
Study Completion
June 30, 2015
Last Updated
April 25, 2017
Results First Posted
April 25, 2017
Record last verified: 2017-03