Clinical trial NCT01343901: An Observational Study on Bevacizumab (Avastin) as First-Line Treatment in Colorectal Cancer Participants With Potentially Resectable Liver Metastases
Official title: A Cohort Study of Patients With Metastatic Colorectal Cancer Treated With Avastin® as First-line Therapy for Liver Metastases Considered as Potentially Resectable
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-28
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with colorectal cancer and hepatic or hepatic and pulmonary metastases

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery
timeFrame: Baseline up to 36 months
measure: Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery
timeFrame: Baseline up to 36 months
Secondary outcomes:
measure: Percentage of Participants With at Least One Disease and Comorbidity at Day 0
timeFrame: Day 0
measure: Percentage of Participants With Different Previous Therapies at Day 0
timeFrame: Day 0
measure: Mean Number of Cumulated Cycles of Bevacizumab Over the Study Period
timeFrame: Baseline up to 36 months
measure: Percentage of Participants Who Received at Least One Chemotherapy Over the Study Period
timeFrame: Baseline up to 36 months
measure: Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment
timeFrame: Baseline up to 36 months
measure: Percentage of Participants With Disease Progression or Death
timeFrame: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months
measure: Progression-free Survival (PFS)
timeFrame: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months
measure: Percentage of Participants With Disease Relapse
timeFrame: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months
measure: Relapse-free Survival (RFS)
timeFrame: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months
measure: Percentage of Participants Who Died
timeFrame: Baseline until death; assessed up to 36 months
measure: Overall Survival (OS)
timeFrame: Baseline until death, assessed up to 36 months
measure: Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery
timeFrame: Baseline up to 36 months
measure: Number of Cumulated Cycles of First Line Bevacizumab at Day 0
timeFrame: Day 0
measure: Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0
timeFrame: Day 0
measure: Total Duration of First Line Bevacizumab Treatment at Day 0
timeFrame: Day 0
measure: Percentage of Participants With Unresectability Criteria
timeFrame: Day 0
Other outcomes:
Locations:
city: Agen
country: France
facility: Clinique Esquirol Saint Hilaire
city: Aix En Provence
country: France
facility: C.H. Du Pays D'aix En Provence Service du Dr Blanc
city: Aix En Provence
country: France
facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
city: Alencon
country: France
facility: Chi D Alencon; Medecine Ambulatoire
city: Ales
country: France
facility: Ch D Ales; Oncologie
city: Amiens
country: France
facility: Hopital Nord; Medecine A
city: Amiens
country: France
facility: Clinique De L Europe; Pmsi
city: Amiens
country: France
facility: Clinique De L Europe; Radiotherapie Chimiotherapie
city: Amilly
country: France
facility: Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero
city: Angers
country: France
facility: Hotel Dieu; Medecine A
city: Arras
country: France
facility: Centre Radiotherapie Marie Curie
city: Arras
country: France
facility: HOP Prive Arras Les Bonnettes; Chimiotherapie
city: Auxerre
country: France
facility: Polyclinique Sainte Marguerite; Chimiotherapie
city: Bayonne
country: France
facility: Chic Cote Basque Bayonne; Medecine II
city: Bayonne
country: France
facility: Clinique Saint Etienne; Medecine
city: Beauvais
country: France
facility: Centre Hospitalier; Hematologie-Oncologie
city: Belfort
country: France
facility: Ch de Belfort; Hopital de Jour
city: Besancon
country: France
facility: Hopital Jean Minjoz; Gastro Enterologie
city: Besancon
country: France
facility: HOPITAL JEAN MINJOZ; Oncologie
city: Beuvry
country: France
facility: Centre Pierre Curie
city: Beziers
country: France
facility: Centre De Radiotherapie Oncodoc
city: Beziers
country: France
facility: Clinique Champeau Mediterranee; Radiotherapie Oncologie
city: Bordeaux
country: France
facility: Clinique Tivoli; Sce Radiotherapie
city: Bordeaux
country: France
facility: Fondation Bergonie; Gastro-Enterologie
city: Bordeaux
country: France
facility: Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie
city: Bourg En Bresse
country: France
facility: Clinique Du Docteur Convert; Medecine
city: Bourg En Bresse
country: France
facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie
city: Bourg En Bresse
country: France
facility: Ch De Fleyriat; Gastro Enterologie
city: Bourgoin Jallieu
country: France
facility: Ch Pierre Oudot; Gastro Enterologie
city: Cahors
country: France
facility: Ch Jean Rougier; Oncologie Gastro Enterologie
city: Caluire Et Cuire
country: France
facility: Infirmerie Protestante; Endos Digestive Coelioscopie
city: Carcassonne
country: France
facility: Ch Antoine Gayraud; Oncologie
city: Challes Les Eaux
country: France
facility: Cabinet Medical
city: Chambery
country: France
facility: Ch de Chambery; Gastro Enterologie
city: Charleville Mezieres
country: France
facility: Hopital Manchester; Gastro Enterologie
city: Cherbourg Octeville
country: France
facility: CH Du Cotentin Site De Cherbourg; Hopital De Jour
city: Cornebarrieu
country: France
facility: Clinique Des Cedres; Medecine 2
city: Creteil
country: France
facility: CHU Henri Mondor; Service d'Oncologie Medicale
city: DAX
country: France
facility: Ch De Dax; Radiotherapie Oncologie
city: Dechy
country: France
facility: Centre Leonard De Vinci;Chimiotherapie
city: Dijon
country: France
facility: Cabinet
city: Dijon
country: France
facility: Centre Georges Francois Leclerc; Oncologie 3
city: Draguignan
country: France
facility: Ch De La Dracenie; Hopital De Jour
city: Druex
country: France
facility: Hopital Victor Jousselin; Gastro Enterologie
city: Eaubonne
country: France
facility: Hopital Simone Veil Eaubonne; Hopital De Jour
city: Evreux
country: France
facility: Clinique Pasteur; Oncologie Medicale, Hematologie
city: Flers
country: France
facility: Ch Jacques Monod;Medecine A4 B4
city: Freyming Merlebach
country: France
facility: Hopital De Freyming; Secteur 1
city: Gien
country: France
facility: Centre Gastro Loire
city: Gleize
country: France
facility: Hopital Nord Ouest;Gastro Enterologie
city: Hayange
country: France
facility: Hopital Alpha Sante De Hayange; Medecine B
city: Hyeres
country: France
facility: Clinique de L' Esperance; Oncologie
city: Hyeres
country: France
facility: Clinique Sainte Marguerite; Oncologie Medicale
city: La Chaussee St Victor
country: France
facility: Polyclinique de Blois; Chimiotherapie Ambulatoire
city: La Roche Sur Yon
country: France
facility: CH Dptal Les Oudairies; Gastro Enterologie
city: La Roche Sur Yon
country: France
facility: CH Dptal Les Oudairies; Hematologie Oncologie
city: La Tronche
country: France
facility: Hopital Albert Michallon; Gastro Enterologie
city: La Tronche
country: France
facility: Hopital Albert Michallon; Radiotherapie
city: Libourne
country: France
facility: Hopital Robert Boulin; Oncologie
city: Lille
country: France
facility: Cabinet Medical
city: Limoges
country: France
facility: Clinique Chenieux; Oncology
city: Longjumeau
country: France
facility: Ch De Longjumeau; Hopital De Jour Et Semaine
city: Lorient
country: France
facility: CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie
city: Lormont
country: France
facility: Clinique Des 4 Pavillons; Chimiotherapie
city: Lyon
country: France
facility: Hia Desgenettes; Oncologie Hematologie
city: Lyon
country: France
facility: Hopital De La Croix Rousse;Hepato Gastro Entero
city: Lyon
country: France
facility: Clinique De La Sauvegarde; Chimiotherapie
city: Lyon
country: France
facility: Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz; Cancerologie
city: Mareuil Les Meaux
country: France
facility: Clinique Saint Faron; Sce Oncologie Radiotherapie
city: Marseille
country: France
facility: Fondation Hopital Saint Joseph; Gastro-Enterologie
city: Meaux
country: France
facility: Ch De Meaux; Gastro Enterologie
city: Metz Tessy
country: France
facility: Chra; Gastro Enterologie
city: Metz
country: France
facility: Hopital Clinique Claude Bernard; Oncologie Medicale
city: Mont-de-marsan
country: France
facility: Hopital Layne; Medecine Ambulatoire
city: Montbeliard
country: France
facility: Site Le Mittan; Hopital De Jour
city: Montelimar
country: France
facility: Ch De Montelimar; Gastro Enterologie Oncologie
city: Montfermeil
country: France
facility: Ghi Le Raincy Montfermeil; Gastro Medecine Interne
city: Montfermeil
country: France
facility: Ghi Le Raincy Montfermeil; Radiotherapie Oncologie
city: Montlucon
country: France
facility: Ctre Radiotherapie Joseph Belot; Hematologie
city: Montpellier
country: France
facility: Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie
city: Mougins
country: France
facility: Centre Azureen De Cancerologie; Cons externes
city: Nancy
country: France
facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
city: Narbonne
country: France
facility: Polyclinique Du Languedoc; Chimiotherapie
city: Nemours
country: France
facility: Ch De Nemours; Medecine 1
city: Nice
country: France
facility: Clinique Du Parc Imperial; Chimiotherapie
city: Nice
country: France
facility: Hopital De L Archet;Gastro Nutrition Oncologie
city: Nimes
country: France
facility: Hopital Caremeau; Gastro Enterologie
city: Paris
country: France
facility: Hopital Des Diaconesses; Hopital De Jour
city: Paris
country: France
facility: Ch Pitie Salpetriere; Oncologie Medicale
city: Paris
country: France
facility: GH Paris Saint Joseph; Hopital De Jour Oncologie
city: Paris
country: France
facility: Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie
city: Paris
country: France
facility: HOPITAL TENON; Cancerologie Medicale
city: Perigueux
country: France
facility: Clinique Francheville; Radiotherapie
city: Perigueux
country: France
facility: Ch De Perigueux; Had Perigueux
city: Perpignan
country: France
facility: Centre Catalan D' Oncologie
city: Perpignan
country: France
facility: Hopital Saint Jean; Centre Henri Pujol
city: Pessac
country: France
facility: Hopital Du Haut-Leveque; Gastro-Enterologie
city: Pierre Benite
country: France
facility: Ch Lyon Sud; Gastro Secteur Jules Courmont
city: Plerin
country: France
facility: Clinique Armoricaine Radiologie; Hopital de Jour
city: Poitiers
country: France
facility: Chu La Miletrie; Gastro Enterologie Endoscopies
city: Pontoise
country: France
facility: Hopital Rene Dubos; Service de Medecine Generale & de Gastro-Enterologie
city: Rennes
country: France
facility: Centre Eugene Marquis; Unite Huguenin
city: Rouen
country: France
facility: Hopital Charles Nicolle; Endoscopies Digestives
city: Rouen
country: France
facility: Clinique De L Europe; Chimiotherapie
city: Rouen
country: France
facility: Clinique Saint Hilaire; Sce Chimiotherapie
city: Saint Gregoire
country: France
facility: Chp Saint Gregoire; Cancerologie Radiotherapie
city: Saint Herblain
country: France
facility: Ico Rene Gauducheau; Oncologie
city: Saint Jean
country: France
facility: Clinique de L'Union; Oncologie
city: Salouel
country: France
facility: Centre Hospitalier General; Oncologie Medicale
city: St Brieuc
country: France
facility: Hopital Yves Le Foll; Hepatologie Gastro Enterologie
city: St Germain En Laye
country: France
facility: Chi Poissy Saint Germain En Laye; Centre Coordination Cancerologie
city: St Lo
country: France
facility: Memorial France Etats Unis; Hopital De Jour
city: St Martin Boulogne
country: France
facility: CMCO De La Cote D Opale; Auberge De Jour
city: St. Priest
country: France
facility: Cabinet Medical
city: Strasbourg
country: France
facility: Clinique Chir De L Orangerie; Chimiotherapie
city: Strasbourg
country: France
facility: Clinique Saint Anne; Hopital De Jour
city: Strasbourg
country: France
facility: Centre Paul Strauss; Oncologie Medicale
city: Strasbourg
country: France
facility: Clinique Sainte Anne; Hospitalisation
city: Toulon
country: France
facility: Hopital Font Pre; Hemato-Oncologie
city: Toulouse
country: France
facility: Hopital Purpan; Chir Generale Digestive
city: Toulouse
country: France
facility: Clinique Pasteur; Oncologie Medicale
city: Verdun
country: France
facility: Hopital Saint Nicolas; Medecine A
city: Vichy
country: France
facility: Hopital Jacques Lacarin; Hopital De Jour
city: Villejuif
country: France
facility: Hopital Paul Brousse; Hematologie
city: Villeneuve St Georges
country: France
facility: Chi De Villeneuve St Georges; Oncologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: