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Colorectal CancerPICASSONCT01343901

An Observational Study on Bevacizumab (Avastin) as First-Line Treatment in Colorectal Cancer Participants With Potentially Resectable Liver Metastases

An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 126 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Bevacizumab
How many people
210 participants
Where
126 sitesFrance
Study dates
30 Sep 2010to 30 Jun 2015
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with colorectal cancer and hepatic or hepatic and pulmonary metastases

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

126 sites in 1 country.

126 sites in 1 country

France126 sites

  • Clinique Esquirol Saint Hilaire

    Agen, 47002

  • C.H. Du Pays D'aix En Provence Service du Dr Blanc

    Aix-en-Provence, 13616

  • Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

    Aix-en-Provence, 13617

  • Chi D Alencon; Medecine Ambulatoire

    Alençon, 61014

  • Ch D Ales; Oncologie

    Alès, 30103

  • Hopital Nord; Medecine A

    Amiens, 80054

  • Clinique De L Europe; Pmsi

    Amiens, 80090

  • Clinique De L Europe; Radiotherapie Chimiotherapie

    Amiens, 80090

  • Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero

    Amilly, 45200

  • Hotel Dieu; Medecine A

    Angers, 49093

  • Centre Radiotherapie Marie Curie

    Arras, 62000

  • HOP Prive Arras Les Bonnettes; Chimiotherapie

    Arras, 62012

  • Polyclinique Sainte Marguerite; Chimiotherapie

    Auxerre, 89000

  • Chic Cote Basque Bayonne; Medecine II

    Bayonne, 64109

  • Clinique Saint Etienne; Medecine

    Bayonne, 64115

  • Centre Hospitalier; Hematologie-Oncologie

    Beauvais, 60021

  • Ch de Belfort; Hopital de Jour

    Belfort, 90016

  • Hopital Jean Minjoz; Gastro Enterologie

    Besançon, 25030

  • HOPITAL JEAN MINJOZ; Oncologie

    Besançon, 25030

  • Centre Pierre Curie

    Beuvry, 62660

  • Centre De Radiotherapie Oncodoc

    Béziers, 34500

  • Clinique Champeau Mediterranee; Radiotherapie Oncologie

    Béziers, 34535

  • Clinique Tivoli; Sce Radiotherapie

    Bordeaux, 33000

  • Fondation Bergonie; Gastro-Enterologie

    Bordeaux, 33076

  • Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie

    Bordeaux, 33077

  • Clinique Du Docteur Convert; Medecine

    Bourg-en-Bresse, 01004

  • Centre Hospitalier Fleyriat; Oncologie/Hematologie

    Bourg-en-Bresse, 01012

  • Ch De Fleyriat; Gastro Enterologie

    Bourg-en-Bresse, 01012

  • Ch Pierre Oudot; Gastro Enterologie

    Bourgoin, 38317

  • Ch Jean Rougier; Oncologie Gastro Enterologie

    Cahors, 46005

  • Infirmerie Protestante; Endos Digestive Coelioscopie

    Caluire-et-Cuire, 69300

  • Ch Antoine Gayraud; Oncologie

    Carcassonne, 11890

  • Cabinet Medical

    Challes-les-Eaux, 73190

  • Ch de Chambery; Gastro Enterologie

    Chambéry, 73011

  • Hopital Manchester; Gastro Enterologie

    Charleville-Mézières, 08011

  • CH Du Cotentin Site De Cherbourg; Hopital De Jour

    Cherbourg Octeville, 50102

  • Clinique Des Cedres; Medecine 2

    Cornebarrieu, 31700

  • CHU Henri Mondor; Service d'Oncologie Medicale

    Créteil, 94010

  • Ch De Dax; Radiotherapie Oncologie

    Dax, 40107

  • Centre Leonard De Vinci;Chimiotherapie

    Dechy, 59187

  • Cabinet

    Dijon, 21000

  • Centre Georges Francois Leclerc; Oncologie 3

    Dijon, 21079

  • Ch De La Dracenie; Hopital De Jour

    Draguignan, 83007

  • Hopital Victor Jousselin; Gastro Enterologie

    Druex, 28102

  • Hopital Simone Veil Eaubonne; Hopital De Jour

    Eaubonne, 95602

  • Clinique Pasteur; Oncologie Medicale, Hematologie

    Évreux, 27025

  • Ch Jacques Monod;Medecine A4 B4

    Flers, 61104

  • Hopital De Freyming; Secteur 1

    Freyming-Merlebach, 57804

  • Centre Gastro Loire

    Gien, 45 500

  • Hopital Nord Ouest;Gastro Enterologie

    Gleizé, 69400

  • Hopital Alpha Sante De Hayange; Medecine B

    Hayange, 57701

  • Clinique de L' Esperance; Oncologie

    Hyères, 83400

  • Clinique Sainte Marguerite; Oncologie Medicale

    Hyères, 83400

  • Polyclinique de Blois; Chimiotherapie Ambulatoire

    La Chaussée-Saint-Victor, 41260

  • CH Dptal Les Oudairies; Gastro Enterologie

    La Roche-sur-Yon, 85925

  • CH Dptal Les Oudairies; Hematologie Oncologie

    La Roche-sur-Yon, 85925

  • Hopital Albert Michallon; Gastro Enterologie

    La Tronche, 38700

  • Hopital Albert Michallon; Radiotherapie

    La Tronche, 38700

  • Hopital Robert Boulin; Oncologie

    Libourne, 33505

  • Cabinet Medical

    Lille, 59800

  • Clinique Chenieux; Oncology

    Limoges, 87039

  • Ch De Longjumeau; Hopital De Jour Et Semaine

    Longjumeau, 91161

  • CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie

    Lorient, 56322

  • Clinique Des 4 Pavillons; Chimiotherapie

    Lormont, 33310

  • Hia Desgenettes; Oncologie Hematologie

    Lyon, 69275

  • Hopital De La Croix Rousse;Hepato Gastro Entero

    Lyon, 69317

  • Clinique De La Sauvegarde; Chimiotherapie

    Lyon, 69337

  • Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie

    Lyon, 69365

  • Hopital Prive Jean Mermoz; Cancerologie

    Lyon, 69373

  • Clinique Saint Faron; Sce Oncologie Radiotherapie

    Mareuil-lès-Meaux, 77100

  • Fondation Hopital Saint Joseph; Gastro-Enterologie

    Marseille, 13285

  • Ch De Meaux; Gastro Enterologie

    Meaux, 77104

  • Hopital Clinique Claude Bernard; Oncologie Medicale

    Metz, 57000

  • Chra; Gastro Enterologie

    Metz-Tessy, 74370

  • Hopital Layne; Medecine Ambulatoire

    Mont-de-Marsan, 40024

  • Site Le Mittan; Hopital De Jour

    Montbéliard, 25209

  • Ch De Montelimar; Gastro Enterologie Oncologie

    Montélimar, 26216

  • Ghi Le Raincy Montfermeil; Gastro Medecine Interne

    Montfermeil, 93370

  • Ghi Le Raincy Montfermeil; Radiotherapie Oncologie

    Montfermeil, 93370

  • Ctre Radiotherapie Joseph Belot; Hematologie

    Montluçon, 03100

  • Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie

    Montpellier, 34967

  • Centre Azureen De Cancerologie; Cons externes

    Mougins, 06250

  • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

    Nancy, 54100

  • Polyclinique Du Languedoc; Chimiotherapie

    Narbonne, 11780

  • Ch De Nemours; Medecine 1

    Nemours, 77796

  • Clinique Du Parc Imperial; Chimiotherapie

    Nice, 06000

  • Hopital De L Archet;Gastro Nutrition Oncologie

    Nice, 06202

  • Hopital Caremeau; Gastro Enterologie

    Nîmes, 30029

  • Hopital Des Diaconesses; Hopital De Jour

    Paris, 75571

  • Ch Pitie Salpetriere; Oncologie Medicale

    Paris, 75651

  • GH Paris Saint Joseph; Hopital De Jour Oncologie

    Paris, 75674

  • Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie

    Paris, 75877

  • HOPITAL TENON; Cancerologie Medicale

    Paris, 75970

  • Clinique Francheville; Radiotherapie

    Périgueux, 24000

  • Ch De Perigueux; Had Perigueux

    Périgueux, 24019

  • Centre Catalan D' Oncologie

    Perpignan, 66000

  • Hopital Saint Jean; Centre Henri Pujol

    Perpignan, 66046

  • Hopital Du Haut-Leveque; Gastro-Enterologie

    Pessac, 33604

  • Ch Lyon Sud; Gastro Secteur Jules Courmont

    Pierre-Bénite, 69495

  • Clinique Armoricaine Radiologie; Hopital de Jour

    Plérin, 22190

  • Chu La Miletrie; Gastro Enterologie Endoscopies

    Poitiers, 86021

  • Hopital Rene Dubos; Service de Medecine Generale & de Gastro-Enterologie

    Pontoise, 95300

  • Centre Eugene Marquis; Unite Huguenin

    Rennes, 35042

  • Hopital Charles Nicolle; Endoscopies Digestives

    Rouen, 76031

  • Clinique De L Europe; Chimiotherapie

    Rouen, 76040

  • Clinique Saint Hilaire; Sce Chimiotherapie

    Rouen, 76044

  • Hopital Yves Le Foll; Hepatologie Gastro Enterologie

    Saint-Brieuc, 22027

  • Chi Poissy Saint Germain En Laye; Centre Coordination Cancerologie

    Saint-Germain-en-Laye, 78105

  • Chp Saint Gregoire; Cancerologie Radiotherapie

    Saint-Grégoire, 35768

  • Ico Rene Gauducheau; Oncologie

    Saint-Herblain, 44805

  • Clinique de L'Union; Oncologie

    Saint-Jean, 31240

  • Memorial France Etats Unis; Hopital De Jour

    Saint-Lô, 50009

  • CMCO De La Cote D Opale; Auberge De Jour

    Saint-Martin-Boulogne, 62280

  • Cabinet Medical

    Saint-Priest, 69800

  • Centre Hospitalier General; Oncologie Medicale

    Salouël, 80480

  • Clinique Chir De L Orangerie; Chimiotherapie

    Strasbourg, 67010

  • Clinique Saint Anne; Hopital De Jour

    Strasbourg, 67010

  • Centre Paul Strauss; Oncologie Medicale

    Strasbourg, 67065

  • Clinique Sainte Anne; Hospitalisation

    Strasbourg, 67085

  • Hopital Font Pre; Hemato-Oncologie

    Toulon, 83056

  • Hopital Purpan; Chir Generale Digestive

    Toulouse, 31059

  • Clinique Pasteur; Oncologie Medicale

    Toulouse, 31076

  • Hopital Saint Nicolas; Medecine A

    Verdun, 55107

  • Hopital Jacques Lacarin; Hopital De Jour

    Vichy, 3201

  • Hopital Paul Brousse; Hematologie

    Villejuif, 94804

  • Chi De Villeneuve St Georges; Oncologie

    Villeneuve-Saint-Georges, 94195

Other trials in France

About this study

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

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.

Being tested
Bevacizumab
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called Avastin

    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.

Study groups in NCT01343901
Study groupRoleWhat they receive
BevacizumabParticipants 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.
Receives: Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline up to 36 months

  2. 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.

    Measured: Baseline up to 36 months

Secondary outcomes (16)

  1. 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.

    Measured: Day 0

  2. 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.

    Measured: Day 0

  3. Mean Number of Cumulated Cycles of Bevacizumab Over the Study Period

    Measured: Baseline up to 36 months

  4. Percentage of Participants Who Received at Least One Chemotherapy Over the Study Period

    Measured: Baseline up to 36 months

  5. 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.

    Measured: Baseline up to 36 months

  6. 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.

    Measured: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months

  7. 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.

    Measured: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months

  8. 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.

    Measured: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months

  9. 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.

    Measured: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months

  10. Percentage of Participants Who Died

    Measured: Baseline until death; assessed up to 36 months

  11. Overall Survival (OS)

    OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.

    Measured: Baseline until death, assessed up to 36 months

  12. 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%).

    Measured: Baseline up to 36 months

  13. Number of Cumulated Cycles of First Line Bevacizumab at Day 0

    Measured: Day 0

  14. Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0

    Measured: Day 0

  15. Total Duration of First Line Bevacizumab Treatment at Day 0

    Measured: Day 0

  16. Percentage of Participants With Unresectability Criteria

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2011 (estimated)
  2. Study start30 Sep 2010
  3. Primary completion30 Jun 2015
  4. Study completion30 Jun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01343901
Sponsor's protocol ID
ML22999
Acronym
PICASSO
Status last verified
Mar 2017
First submitted
27 Apr 2011
Last updated
25 Apr 2017

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 126 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 126 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery (time frame: Baseline up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01343901.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.

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