An Observational Study on Bevacizumab (Avastin) as First-Line Treatment in Colorectal Cancer Participants With Potentially Resectable Liver Metastases
- Registration Number
- NCT01343901
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- Participants with colorectal cancer with exclusively hepatic or hepatic and pulmonary metastases
- First-line treatment with bevacizumab for potentially resectable metastatic disease
- Outright resectable disease
- Clearly inoperable disease
- Participation in a clinical trial evaluating a cytotoxic anticancer treatment and/or an innovative therapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Bevacizumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery Baseline up to 36 months 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).
Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery Baseline up to 36 months The percentage of participants with no detectable metastatic disease after a complete response without surgery (missing metastasis) was reported.
- Secondary Outcome Measures
Name Time Method Relapse-free Survival (RFS) Baseline until disease progression or death, whichever occurred first, assessed up to 36 months 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.
Percentage of Participants Who Died Baseline until death; assessed up to 36 months Overall Survival (OS) Baseline until death, assessed up to 36 months OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.
Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery Baseline up to 36 months 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%).
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 Percentage of Participants With at Least One Disease and Comorbidity at Day 0 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.
Percentage of Participants With Different Previous Therapies at Day 0 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.
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 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.
Percentage of Participants With Disease Progression or Death Baseline until disease progression or death, whichever occurred first, assessed up to 36 months 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.
Progression-free Survival (PFS) Baseline until disease progression or death, whichever occurred first, assessed up to 36 months 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.
Percentage of Participants With Disease Relapse Baseline until disease progression or death, whichever occurred first, assessed up to 36 months 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.
Trial Locations
- Locations (124)
Fondation Bergonie; Gastro-Enterologie
🇫🇷Bordeaux, France
Clinique De L Europe; Pmsi
🇫🇷Amiens, France
Clinique Esquirol Saint Hilaire
🇫🇷Agen, France
Centre De Radiotherapie Oncodoc
🇫🇷Beziers, France
C.H. Du Pays D'aix En Provence Service du Dr Blanc
🇫🇷Aix En Provence, France
Hia Desgenettes; Oncologie Hematologie
🇫🇷Lyon, France
Ch De Dax; Radiotherapie Oncologie
🇫🇷DAX, France
Hopital Manchester; Gastro Enterologie
🇫🇷Charleville Mezieres, France
Centre Georges Francois Leclerc; Oncologie 3
🇫🇷Dijon, France
Clinique Saint Faron; Sce Oncologie Radiotherapie
🇫🇷Mareuil Les Meaux, France
Hopital Layne; Medecine Ambulatoire
🇫🇷Mont-de-marsan, France
Clinique Saint Hilaire; Sce Chimiotherapie
🇫🇷Rouen, France
Hopital Font Pre; Hemato-Oncologie
🇫🇷Toulon, France
CHU Henri Mondor; Service d'Oncologie Medicale
🇫🇷Creteil, France
Centre Leonard De Vinci;Chimiotherapie
🇫🇷Dechy, France
Cabinet
🇫🇷Dijon, France
Ch De La Dracenie; Hopital De Jour
🇫🇷Draguignan, France
Hopital Victor Jousselin; Gastro Enterologie
🇫🇷Druex, France
Clinique Pasteur; Oncologie Medicale, Hematologie
🇫🇷Evreux, France
Hopital Simone Veil Eaubonne; Hopital De Jour
🇫🇷Eaubonne, France
Ch Jacques Monod;Medecine A4 B4
🇫🇷Flers, France
Hopital De Freyming; Secteur 1
🇫🇷Freyming Merlebach, France
Hopital Nord Ouest;Gastro Enterologie
🇫🇷Gleize, France
Clinique de L' Esperance; Oncologie
🇫🇷Hyeres, France
Hopital Alpha Sante De Hayange; Medecine B
🇫🇷Hayange, France
CH Dptal Les Oudairies; Gastro Enterologie
🇫🇷La Roche Sur Yon, France
Clinique Sainte Marguerite; Oncologie Medicale
🇫🇷Hyeres, France
Polyclinique de Blois; Chimiotherapie Ambulatoire
🇫🇷La Chaussee St Victor, France
CH Dptal Les Oudairies; Hematologie Oncologie
🇫🇷La Roche Sur Yon, France
Hopital Albert Michallon; Radiotherapie
🇫🇷La Tronche, France
Hopital Robert Boulin; Oncologie
🇫🇷Libourne, France
Clinique Chenieux; Oncology
🇫🇷Limoges, France
Ch De Longjumeau; Hopital De Jour Et Semaine
🇫🇷Longjumeau, France
CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie
🇫🇷Lorient, France
Hopital De La Croix Rousse;Hepato Gastro Entero
🇫🇷Lyon, France
Clinique De La Sauvegarde; Chimiotherapie
🇫🇷Lyon, France
Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie
🇫🇷Lyon, France
Fondation Hopital Saint Joseph; Gastro-Enterologie
🇫🇷Marseille, France
Clinique Des 4 Pavillons; Chimiotherapie
🇫🇷Lormont, France
Clinique Francheville; Radiotherapie
🇫🇷Perigueux, France
Centre Catalan D' Oncologie
🇫🇷Perpignan, France
Ch Lyon Sud; Gastro Secteur Jules Courmont
🇫🇷Pierre Benite, France
Clinique Armoricaine Radiologie; Hopital de Jour
🇫🇷Plerin, France
Hopital Clinique Claude Bernard; Oncologie Medicale
🇫🇷Metz, France
Chra; Gastro Enterologie
🇫🇷Metz Tessy, France
Site Le Mittan; Hopital De Jour
🇫🇷Montbeliard, France
Ch De Montelimar; Gastro Enterologie Oncologie
🇫🇷Montelimar, France
Ghi Le Raincy Montfermeil; Gastro Medecine Interne
🇫🇷Montfermeil, France
Ctre Radiotherapie Joseph Belot; Hematologie
🇫🇷Montlucon, France
Polyclinique Du Languedoc; Chimiotherapie
🇫🇷Narbonne, France
Clinique Du Parc Imperial; Chimiotherapie
🇫🇷Nice, France
Ghi Le Raincy Montfermeil; Radiotherapie Oncologie
🇫🇷Montfermeil, France
Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie
🇫🇷Montpellier, France
Ch De Nemours; Medecine 1
🇫🇷Nemours, France
Chu La Miletrie; Gastro Enterologie Endoscopies
🇫🇷Poitiers, France
Hopital Rene Dubos; Service de Medecine Generale & de Gastro-Enterologie
🇫🇷Pontoise, France
Hopital Charles Nicolle; Endoscopies Digestives
🇫🇷Rouen, France
Clinique Chir De L Orangerie; Chimiotherapie
🇫🇷Strasbourg, France
Ico Rene Gauducheau; Oncologie
🇫🇷Saint Herblain, France
Hopital Saint Nicolas; Medecine A
🇫🇷Verdun, France
Ch De Meaux; Gastro Enterologie
🇫🇷Meaux, France
Hopital Albert Michallon; Gastro Enterologie
🇫🇷La Tronche, France
Centre Gastro Loire
🇫🇷Gien, France
Hopital Prive Jean Mermoz; Cancerologie
🇫🇷Lyon, France
Hopital Des Diaconesses; Hopital De Jour
🇫🇷Paris, France
Ch Pitie Salpetriere; Oncologie Medicale
🇫🇷Paris, France
Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie
🇫🇷Paris, France
Clinique Pasteur; Oncologie Medicale
🇫🇷Toulouse, France
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
🇫🇷Aix En Provence, France
Hopital Nord; Medecine A
🇫🇷Amiens, France
Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero
🇫🇷Amilly, France
Chi D Alencon; Medecine Ambulatoire
🇫🇷Alencon, France
Ch D Ales; Oncologie
🇫🇷Ales, France
Clinique De L Europe; Radiotherapie Chimiotherapie
🇫🇷Amiens, France
Centre Radiotherapie Marie Curie
🇫🇷Arras, France
Hotel Dieu; Medecine A
🇫🇷Angers, France
HOP Prive Arras Les Bonnettes; Chimiotherapie
🇫🇷Arras, France
Polyclinique Sainte Marguerite; Chimiotherapie
🇫🇷Auxerre, France
Clinique Saint Etienne; Medecine
🇫🇷Bayonne, France
Ch de Belfort; Hopital de Jour
🇫🇷Belfort, France
Chic Cote Basque Bayonne; Medecine II
🇫🇷Bayonne, France
HOPITAL JEAN MINJOZ; Oncologie
🇫🇷Besancon, France
Centre Hospitalier; Hematologie-Oncologie
🇫🇷Beauvais, France
Hopital Jean Minjoz; Gastro Enterologie
🇫🇷Besancon, France
Centre Pierre Curie
🇫🇷Beuvry, France
Clinique Tivoli; Sce Radiotherapie
🇫🇷Bordeaux, France
Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie
🇫🇷Bordeaux, France
Clinique Du Docteur Convert; Medecine
🇫🇷Bourg En Bresse, France
Clinique Champeau Mediterranee; Radiotherapie Oncologie
🇫🇷Beziers, France
Centre Hospitalier Fleyriat; Oncologie/Hematologie
🇫🇷Bourg En Bresse, France
Ch Pierre Oudot; Gastro Enterologie
🇫🇷Bourgoin Jallieu, France
Ch De Fleyriat; Gastro Enterologie
🇫🇷Bourg En Bresse, France
Infirmerie Protestante; Endos Digestive Coelioscopie
🇫🇷Caluire Et Cuire, France
Ch Jean Rougier; Oncologie Gastro Enterologie
🇫🇷Cahors, France
Ch Antoine Gayraud; Oncologie
🇫🇷Carcassonne, France
Cabinet Medical
🇫🇷St. Priest, France
Ch de Chambery; Gastro Enterologie
🇫🇷Chambery, France
CH Du Cotentin Site De Cherbourg; Hopital De Jour
🇫🇷Cherbourg Octeville, France
Clinique Des Cedres; Medecine 2
🇫🇷Cornebarrieu, France
Centre Azureen De Cancerologie; Cons externes
🇫🇷Mougins, France
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
🇫🇷Nancy, France
Hopital De L Archet;Gastro Nutrition Oncologie
🇫🇷Nice, France
Hopital Caremeau; Gastro Enterologie
🇫🇷Nimes, France
GH Paris Saint Joseph; Hopital De Jour Oncologie
🇫🇷Paris, France
HOPITAL TENON; Cancerologie Medicale
🇫🇷Paris, France
Ch De Perigueux; Had Perigueux
🇫🇷Perigueux, France
Hopital Saint Jean; Centre Henri Pujol
🇫🇷Perpignan, France
Hopital Du Haut-Leveque; Gastro-Enterologie
🇫🇷Pessac, France
Centre Eugene Marquis; Unite Huguenin
🇫🇷Rennes, France
Centre Hospitalier General; Oncologie Medicale
🇫🇷Salouel, France
Clinique De L Europe; Chimiotherapie
🇫🇷Rouen, France
Chp Saint Gregoire; Cancerologie Radiotherapie
🇫🇷Saint Gregoire, France
Clinique de L'Union; Oncologie
🇫🇷Saint Jean, France
Hopital Yves Le Foll; Hepatologie Gastro Enterologie
🇫🇷St Brieuc, France
Memorial France Etats Unis; Hopital De Jour
🇫🇷St Lo, France
Chi Poissy Saint Germain En Laye; Centre Coordination Cancerologie
🇫🇷St Germain En Laye, France
CMCO De La Cote D Opale; Auberge De Jour
🇫🇷St Martin Boulogne, France
Centre Paul Strauss; Oncologie Medicale
🇫🇷Strasbourg, France
Clinique Saint Anne; Hopital De Jour
🇫🇷Strasbourg, France
Clinique Sainte Anne; Hospitalisation
🇫🇷Strasbourg, France
Hopital Purpan; Chir Generale Digestive
🇫🇷Toulouse, France
Hopital Jacques Lacarin; Hopital De Jour
🇫🇷Vichy, France
Hopital Paul Brousse; Hematologie
🇫🇷Villejuif, France
Chi De Villeneuve St Georges; Oncologie
🇫🇷Villeneuve St Georges, France