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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Bevacizumab

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• France
  • Agen, France, 47002
    • Clinique Esquirol Saint Hilaire
  • Aix En Provence, France, 13616
    • C.H. Du Pays D'aix En Provence Service du Dr Blanc
  • Aix En Provence, France, 13617
    • Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
  • Alencon, France, 61014
    • Chi D Alencon; Medecine Ambulatoire
  • Ales, France, 30103
    • Ch D Ales; Oncologie
  • Amiens, France, 80090
    • Clinique De L Europe; Radiotherapie Chimiotherapie
  • Amiens, France, 80090
    • Clinique De L Europe; Pmsi
  • Amiens, France, 80054
    • Hopital Nord; Medecine A
  • Amilly, France, 45200
    • Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero
  • Angers, France, 49093
    • Hotel Dieu; Medecine A
  • Arras, France, 62012
    • HOP Prive Arras Les Bonnettes; Chimiotherapie
  • Arras, France, 62000
    • Centre Radiotherapie Marie Curie
  • Auxerre, France, 89000
    • Polyclinique Sainte Marguerite; Chimiotherapie
  • Bayonne, France, 64109
    • Chic Cote Basque Bayonne; Medecine II
  • Bayonne, France, 64115
    • Clinique Saint Etienne; Medecine
  • Beauvais, France, 60021
    • Centre Hospitalier; Hematologie-Oncologie
  • Belfort, France, 90016
    • Ch de Belfort; Hopital de Jour
  • Besancon, France, 25030
    • HOPITAL JEAN MINJOZ; Oncologie
  • Besancon, France, 25030
    • Hopital Jean Minjoz; Gastro Enterologie
  • Beuvry, France, 62660
    • Centre Pierre Curie
  • Beziers, France, 34500
    • Centre De Radiotherapie Oncodoc
  • Beziers, France, 34535
    • Clinique Champeau Mediterranee; Radiotherapie Oncologie
  • Bordeaux, France, 33000
    • Clinique Tivoli; Sce Radiotherapie
  • Bordeaux, France, 33076
    • Fondation Bergonie; Gastro-Enterologie
  • Bordeaux, France, 33077
    • Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie
  • Bourg En Bresse, France, 01012
    • Centre Hospitalier Fleyriat; Oncologie/Hematologie
  • Bourg En Bresse, France, 01004
    • Clinique Du Docteur Convert; Medecine
  • Bourg En Bresse, France, 01012
    • Ch De Fleyriat; Gastro Enterologie
  • Bourgoin Jallieu, France, 38317
    • Ch Pierre Oudot; Gastro Enterologie
  • Cahors, France, 46005
    • Ch Jean Rougier; Oncologie Gastro Enterologie
  • Caluire Et Cuire, France, 69300
    • Infirmerie Protestante; Endos Digestive Coelioscopie
  • Carcassonne, France, 11890
    • Ch Antoine Gayraud; Oncologie
  • Challes Les Eaux, France, 73190
    • Cabinet Medical
  • Chambery, France, 73011
    • Ch de Chambery; Gastro Enterologie
  • Charleville Mezieres, France, 08011
    • Hopital Manchester; Gastro Enterologie
  • Cherbourg Octeville, France, 50102
    • CH Du Cotentin Site De Cherbourg; Hopital De Jour
  • Cornebarrieu, France, 31700
    • Clinique Des Cedres; Medecine 2
  • Creteil, France, 94010
    • CHU Henri Mondor; Service d'Oncologie Medicale
  • DAX, France, 40107
    • Ch De Dax; Radiotherapie Oncologie
  • Dechy, France, 59187
    • Centre Leonard De Vinci;Chimiotherapie
  • Dijon, France, 21079
    • Centre Georges Francois Leclerc; Oncologie 3
  • Dijon, France, 21000
    • Cabinet
  • Draguignan, France, 83007
    • Ch De La Dracenie; Hopital De Jour
  • Druex, France, 28102
    • Hopital Victor Jousselin; Gastro Enterologie
  • Eaubonne, France, 95602
    • Hopital Simone Veil Eaubonne; Hopital De Jour
  • Evreux, France, 27025
    • Clinique Pasteur; Oncologie Medicale, Hematologie
  • Flers, France, 61104
    • Ch Jacques Monod;Medecine A4 B4
  • Freyming Merlebach, France, 57804
    • Hopital De Freyming; Secteur 1
  • Gien, France, 45 500
    • Centre Gastro Loire
  • Gleize, France, 69400
    • Hopital Nord Ouest;Gastro Enterologie
  • Hayange, France, 57701
    • Hopital Alpha Sante De Hayange; Medecine B
  • Hyeres, France, 83400
    • Clinique Sainte Marguerite; Oncologie Medicale
  • Hyeres, France, 83400
    • Clinique de L' Esperance; Oncologie
  • La Chaussee St Victor, France, 41260
    • Polyclinique de Blois; Chimiotherapie Ambulatoire
  • La Roche Sur Yon, France, 85925
    • CH Dptal Les Oudairies; Gastro Enterologie
  • La Roche Sur Yon, France, 85925
    • CH Dptal Les Oudairies; Hematologie Oncologie
  • La Tronche, France, 38700
    • Hopital Albert Michallon; Gastro Enterologie
  • La Tronche, France, 38700
    • Hopital Albert Michallon; Radiotherapie
  • Libourne, France, 33505
    • Hopital Robert Boulin; Oncologie
  • Lille, France, 59800
    • Cabinet Medical
  • Limoges, France, 87039
    • Clinique Chenieux; Oncology
  • Longjumeau, France, 91161
    • Ch De Longjumeau; Hopital De Jour Et Semaine
  • Lorient, France, 56322
    • CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie
  • Lormont, France, 33310
    • Clinique Des 4 Pavillons; Chimiotherapie
  • Lyon, France, 69337
    • Clinique De La Sauvegarde; Chimiotherapie
  • Lyon, France, 69373
    • Hopital Prive Jean Mermoz; Cancerologie
  • Lyon, France, 69275
    • Hia Desgenettes; Oncologie Hematologie
  • Lyon, France, 69317
    • Hopital De La Croix Rousse;Hepato Gastro Entero
  • Lyon, France, 69365
    • Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie
  • Mareuil Les Meaux, France, 77100
    • Clinique Saint Faron; Sce Oncologie Radiotherapie
  • Marseille, France, 13285
    • Fondation Hopital Saint Joseph; Gastro-Enterologie
  • Meaux, France, 77104
    • Ch De Meaux; Gastro Enterologie
  • Metz, France, 57000
    • Hopital Clinique Claude Bernard; Oncologie Medicale
  • Metz Tessy, France, 74370
    • Chra; Gastro Enterologie
  • Mont-de-marsan, France, 40024
    • Hopital Layne; Medecine Ambulatoire
  • Montbeliard, France, 25209
    • Site Le Mittan; Hopital De Jour
  • Montelimar, France, 26216
    • Ch De Montelimar; Gastro Enterologie Oncologie
  • Montfermeil, France, 93370
    • Ghi Le Raincy Montfermeil; Gastro Medecine Interne
  • Montfermeil, France, 93370
    • Ghi Le Raincy Montfermeil; Radiotherapie Oncologie
  • Montlucon, France, 03100
    • Ctre Radiotherapie Joseph Belot; Hematologie
  • Montpellier, France, 34967
    • Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie
  • Mougins, France, 06250
    • Centre Azureen De Cancerologie; Cons externes
  • Nancy, France, 54100
    • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
  • Narbonne, France, 11780
    • Polyclinique Du Languedoc; Chimiotherapie
  • Nemours, France, 77796
    • Ch De Nemours; Medecine 1
  • Nice, France, 06000
    • Clinique Du Parc Imperial; Chimiotherapie
  • Nice, France, 06202
    • Hopital De L Archet;Gastro Nutrition Oncologie
  • Nimes, France, 30029
    • Hopital Caremeau; Gastro Enterologie
  • Paris, France, 75970
    • HOPITAL TENON; Cancerologie Medicale
  • Paris, France, 75674
    • GH Paris Saint Joseph; Hopital De Jour Oncologie
  • Paris, France, 75571
    • Hopital Des Diaconesses; Hopital De Jour
  • Paris, France, 75651
    • Ch Pitie Salpetriere; Oncologie Medicale
  • Paris, France, 75877
    • Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie
  • Perigueux, France, 24000
    • Clinique Francheville; Radiotherapie
  • Perigueux, France, 24019
    • Ch De Perigueux; Had Perigueux
  • Perpignan, France, 66000
    • Centre Catalan D' Oncologie
  • Perpignan, France, 66046
    • Hopital Saint Jean; Centre Henri Pujol
  • Pessac, France, 33604
    • Hopital Du Haut-Leveque; Gastro-Enterologie
  • Pierre Benite, France, 69495
    • Ch Lyon Sud; Gastro Secteur Jules Courmont
  • Plerin, France, 22190
    • Clinique Armoricaine Radiologie; Hopital de Jour
  • Poitiers, France, 86021
    • Chu La Miletrie; Gastro Enterologie Endoscopies
  • Pontoise, France, 95300
    • Hopital Rene Dubos; Service de Medecine Generale & de Gastro-Enterologie
  • Rennes, France, 35042
    • Centre Eugene Marquis; Unite Huguenin
  • Rouen, France, 76031
    • Hopital Charles Nicolle; Endoscopies Digestives
  • Rouen, France, 76040
    • Clinique De L Europe; Chimiotherapie
  • Rouen, France, 76044
    • Clinique Saint Hilaire; Sce Chimiotherapie
  • Saint Gregoire, France, 35768
    • Chp Saint Gregoire; Cancerologie Radiotherapie
  • Saint Herblain, France, 44805
    • Ico Rene Gauducheau; Oncologie
  • Saint Jean, France, 31240
    • Clinique de L'Union; Oncologie
  • Salouel, France, 80480
    • Centre Hospitalier General; Oncologie Medicale
  • St Brieuc, France, 22027
    • Hopital Yves Le Foll; Hepatologie Gastro Enterologie
  • St Germain En Laye, France, 78105
    • Chi Poissy Saint Germain En Laye; Centre Coordination Cancerologie
  • St Lo, France, 50009
    • Memorial France Etats Unis; Hopital De Jour
  • St Martin Boulogne, France, 62280
    • CMCO De La Cote D Opale; Auberge De Jour
  • St. Priest, France, 69800
    • Cabinet Medical
  • Strasbourg, France, 67065
    • Centre Paul Strauss; Oncologie Medicale
  • Strasbourg, France, 67010
    • Clinique Chir De L Orangerie; Chimiotherapie
  • Strasbourg, France, 67010
    • Clinique Saint Anne; Hopital De Jour
  • Strasbourg, France, 67085
    • Clinique Sainte Anne; Hospitalisation
  • Toulon, France, 83056
    • Hopital Font Pre; Hemato-Oncologie
  • Toulouse, France, 31076
    • Clinique Pasteur; Oncologie Medicale
  • Toulouse, France, 31059
    • Hopital Purpan; Chir Generale Digestive
  • Verdun, France, 55107
    • Hopital Saint Nicolas; Medecine A
  • Vichy, France, 3201
    • Hopital Jacques Lacarin; Hopital De Jour
  • Villejuif, France, 94804
    • Hopital Paul Brousse; Hematologie
  • Villeneuve St Georges, France, 94195
    • Chi De Villeneuve St Georges; Oncologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with colorectal cancer and hepatic or hepatic and pulmonary metastases

Description

Inclusion Criteria:

• Participants with colorectal cancer with exclusively hepatic or hepatic and pulmonary metastases
• First-line treatment with bevacizumab for potentially resectable metastatic disease

Exclusion Criteria:

• Outright resectable disease
• Clearly inoperable disease
• Participation in a clinical trial evaluating a cytotoxic anticancer treatment and/or an innovative therapy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Bevacizumab; 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.; Other Names: Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With at Least One Disease and Comorbidity at Day 0	Percentage of participants who had any concurrent disease (comorbidity) at Day 0 was reported. Comorbidities included gastrointestinal disease, hypertension, other cardiovascular disease, and other medical history and comorbidities (other than those specified above). Same participant may be counted in more than one category.	Day 0
Percentage of Participants With Different Previous Therapies at Day 0	Previous therapies included neoadjuvant treatment (chemotherapy or chemotherapy + radiotherapy) and adjuvant treatment (FOLFOX [folinic acid+5-fluorouracil+oxaliplatin], LV5FU2 [leucovorin+5-Fluorouracil], capecitabine, or any other adjuvant treatment). Only participants who received neoadjuvant treatment and adjuvant treatment was reported.	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	Percentage of participants who had any concurrent disease (comorbidity) was reported. Comorbidities included gastrointestinal disease, other cardiovascular disease, and other medical history and comorbidities (other than those which are specified above). Same participant may be counted in more than one category.	Baseline up to 36 months
Percentage of Participants With Disease Progression or Death	Disease progression is defined at least a 20 percent (%) increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 millimeter (mm) or persistence of non-target lesions, or appearance of one or more new lesions.	Baseline until disease progression or death, whichever occurred first, assessed up to 36 months
Progression-free Survival (PFS)	Progression-free survival defined as the time elapsed between the Avastin start date and the date of first progressive disease (PD) or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions or appearance of one or more new lesions.	Baseline until disease progression or death, whichever occurred first, assessed up to 36 months
Percentage of Participants With Disease Relapse	Relapse was defined as the presence of metastases post last surgery removing all detectable metastases (A1 criterion [participants without detectable metastatic disease {DMD} after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.	Baseline until disease progression or death, whichever occurred first, assessed up to 36 months
Relapse-free Survival (RFS)	RFS was defined as the time elapsed between the last surgery removing all detectable metastases (A1 criterion [participants without DMD after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.	Baseline until disease progression or death, whichever occurred first, assessed up to 36 months
Percentage of Participants Who Died		Baseline until death; assessed up to 36 months
Overall Survival (OS)	OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.	Baseline until death, assessed up to 36 months
Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery	For the non-detectable liver and lung metastases the categorization based on rate of viable cells were as follows (no viable cells =0%, minimum =1 to 49%, maximum =50 to 100%).	Baseline up to 36 months
Number of Cumulated Cycles of First Line Bevacizumab at Day 0		Day 0
Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0		Day 0
Total Duration of First Line Bevacizumab Treatment at Day 0		Day 0
Percentage of Participants With Unresectability Criteria		Day 0

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2010
• Primary Completion (Actual): June 30, 2015
• Study Completion (Actual): June 30, 2015

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: April 27, 2011
• First Posted (Estimate): April 28, 2011

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: ML22999