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Non-Squamous Non-Small Cell Lung CancerNCT01893268

An Observational Study of Avastin (Bevacizumab) in Elderly Patients With Non-Squamous Non-Small Cell Lung Cancer in Clinical Practice

An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 88 sites in France.

Completed

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

Official record
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Trial summary

This prospective, observational study will assess the effectiveness and safety of Avastin (bevacizumab) as 1st line therapy in elderly patients with advanced non-squamous non-small cell lung cancer in clinical practice. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Non-Squamous Non-Small Cell Lung Cancer
How many people
279 participants
Where
88 sitesFrance
Study dates
25 Jul 2013to 20 Mar 2018
Phase
Observational
Are there results?
None posted in the registry

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Patients aged over 65 years with non-squamous non-small cell lung cancer

Who may be able to join

  • Adult patients, >= 65 years of age
  • Diagnosis of advanced non squamous Non-Small Cell Lung Carcinoma (nsNSCLC, stage IIIB or IV) for whom the physician has decided to initiate a treatment with Avastin combined with chemotherapy as 1st line therapy
  • Having received oral and written information about the study, and having signed a written consent form

Who cannot join

  • Participation in a cancer clinical trial with an investigational medicinal product other than this study
  • Patient previously treated with Avastin
  • Patient under supervision or guardianship

Trial locations and contacts

88 sites in 1 country.

88 sites in 1 country

France88 sites

  • Clinique Du Docteur Calabet; Cromg

    Agen, 47000

  • Ch Du Pays D Aix; Pneumologie

    Aix-en-Provence, 13616

  • Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

    Aix-en-Provence, 13617

  • Cabinet Medical

    Amiens, 80090

  • Centre Hospitalier Uni Ire; Pneumology

    Angers, 49933

  • Chic Cote Basque Bayonne; Pneumologie

    Bayonne, 64109

  • HOPITAL JEAN MINJOZ; Oncologie

    Besançon, 25030

  • CH Germon ET Gauthier; Pneumologie

    Beuvry, 62660

  • Ch De Beziers; Pneumologie

    Béziers, 34525

  • Hopital Avicenne; Cancerologie

    Bobigny, 93009

  • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

    Bordeaux, 33077

  • Centre Hospitalier Fleyriat; Oncologie/Hematologie

    Bourg-en-Bresse, 01012

  • Ch De Fleyriat; Pneumologie 1

    Bourg-en-Bresse, 01012

  • Hia Clermont Tonnerre; Pneumologie

    Brest, 29240

  • Ch De Brive La Gaillarde; Radiotherapie Oncologie

    Brive-la-Gaillarde, 19312

  • Hopital Louis Pradel; Pneumologie

    Bron, 69677

  • Hopital Pierre Nouveau; Pneumologie

    Cannes, 06401

  • Ch Antoine Gayraud; Oncologie

    Carcassonne, 11890

  • Clinique Du Parc; Hematologie

    Castelnau Lez, 34170

  • Ctre Medical Nicolas de Pontoux

    Chalon-sur-Saône, 71100

  • Ch De Chauny; Pneumologie

    Chauny, 02303

  • CH Du Cotentin Site De Cherbourg; Hopital De Jour

    Cherbourg Octeville, 50102

  • Hopital Gabriel Montpied; Service de Pneumologie

    Clermont-Ferrand, 63003

  • Centre Jean Perrin; Hopital De Semaine

    Clermont-Ferrand, 63011

  • Hopital Louis Pasteur; Pneumologie Tabacologie

    Colmar, 68024

  • Centre Hospitalier Alpes Leman CHAL;Pneumologie

    Contamine-sur-Arve, 74130

  • Clinique Des Cedres; Pneumologie

    Cornebarrieu, 31700

  • Centre Hospitalier Intercommunal; Service de Pneumologie

    Créteil, 94010

  • Chu Site Du Bocage;Pneumologie

    Dijon, 21079

  • Ch De La Dracenie; Pneumologie

    Draguignan, 83007

  • Centre D Oncologie Dunkerquois

    Dunkirk, 59240

  • Chi Emile Durkheim Site Epinal; Pneumologie

    Épinal, 88021

  • Chi Alpes Du Sud Site De Gap; Pneumologie

    Gap, 05007

  • Hopital Nord Ouest;Unite 2c

    Gleizé, 69400

  • CH Emmanuel Rain; Oncologie

    Gonesse, 95503

  • Hopital Prive De Chantilly; Medecine

    Gouvieux Chantilly, 60500

  • Hopital D Hayange;Medecine A Et P

    Hyères, 83400

  • Centre Oscar Lambret; Chir Cancerologie General

    Lille, 59000

  • Hopital Saint Vincent; Consult et Explorations

    Lille, 59020

  • Hopital Calmette; Pneumologie Oncologie Ouest

    Lille, 59037

  • Clinique Chenieux; Oncology

    Limoges, 87039

  • Hopital Du Cluzeau; Service de Pathologie Respiratoire

    Limoges, 87042

  • Hopital Dupuytren; Pneumologie

    Limoges, 87042

  • Centre Hospitalier Général; Pneumologie

    Longjumeau, 91161

  • Ch Bretagne Sud Site Scorff; Oncologie Medicale

    Lorient, 56100

  • Centre Medical Parot

    Lyon, 69006

  • Centre Hospitalier François Quesnay; Pneumologie-Neurologie

    Mantes-la-Jolie, 78200

  • Hôpital Saint Joseph; Oncologie Medicale

    Marseille, 13285

  • Centre Hospitalier; Pneumologie

    Metz-Tessy, 74370

  • Hopital Layne; Medecine Ambulatoire

    Mont-de-Marsan, 40024

  • Ch De Montauban; Pneumologie

    Montauban, 82013

  • Hopital Emile Muller;Pneumologie

    Mulhouse, 68070

  • Cabinet Medical

    Nancy, 54000

  • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

    Nancy, 54100

  • Hopital Caremeau; Pneumologie

    Nîmes, 30029

  • Clinique sainte marie; chimiotherapie ambulatoire

    Osny, 95520

  • Hopital Cochin; Unite Fonctionnelle D Oncologie

    Paris, 75014

  • Hopital Saint Louis; Oncologie Medicale

    Paris, 75475

  • Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

    Paris, 75908

  • Centre Catalan D' Oncologie

    Perpignan, 66000

  • Centre Hospitalier Lyon Sud; Pneumologie

    Pierre-Bénite, 69495

  • CH Rene Dubos; Oncologie

    Pontoise, 95300

  • Hopital Laennec; Service de Pneumologie

    Quimper, 29000

  • Ch De Rambouillet; Pneumologie Cardiologie

    Rambouillet, 78514

  • Cabinet

    Reims, 51100

  • Hopital de Pontchaillou; Service de Pneumologie

    Rennes, 35033

  • Clinique Saint Hilaire; Sce Chimiotherapie

    Rouen, 76044

  • Centre Cardiologique Du Nord; Pneumologie

    Saint-Denis, 93200

  • Clinique de L'Union; Oncologie

    Saint-Jean, 31240

  • Cabinet Medical

    Saint-Laurent-du-Var, 06700

  • Hopital Nord; Service de Pneumologie

    Saint-Priest-en-Jarez, 42770

  • Ch De Saint Quentin; Medecine B14

    Saint-Quentin, 02321

  • Ch De Saintonge; Unite 2 Pneumologie

    Saintes, 17108

  • Centre Medical National Mgen; Pneumologie

    Ste Feyre, 23000

  • Centre Paul Strauss; Oncologie Medicale

    Strasbourg, 67065

  • Hopital Bel Air; Pneumologie Allergologie

    Thionville, 57126

  • Hopitaux Du Leman Site Thonon; Pneumologie

    Thonon-les-Bains, 74203

  • Hia Sainte Anne; Pneumologie

    Toulon, 83041

  • Hopital Sainte Musse; Pneumologie

    Toulon, 83056

  • Clinique Pasteur; Pneumologie

    Toulouse, 31076

  • Groupe Oncorad Garonne; Unite Onco Hematologie

    Toulouse, 31300

  • Cabinet Medical

    Tours, 37000

  • Hopital Des Hauts Clos; Pneumologie

    Troyes, 10003

  • Ch De Valence; Medecine 7

    Valence, 26953

  • Centre Alexis Vautrin; Oncologie Medicale

    Vandœuvre-lès-Nancy, 54511

  • Hopital Robert Schuman; Pneumologie

    Vantoux, 57070

  • Gh Mutualiste Les Portes Du Sud; Pneumologie

    Vénissieux, 69200

  • Hopital Saint Nicolas; Pneumologie

    Verdun, 55107

Other trials in France

About this study

Official title: Therapeutic Strategies Including Avastin as 1st Line Therapy in Elderly Patients Suffering From Advanced (IIIB/IV Stage) Non-squamous Non-small Cell Lung Cancer, in Routine Clinical Practice.

This prospective, observational study will assess the effectiveness and safety of Avastin (bevacizumab) as 1st line therapy in elderly patients with advanced non-squamous non-small cell lung cancer in clinical practice. Therapy with Avastin and standard chemotherapy will be administered according to the treating physician. Data will be collected for approximately 4 years.

What participants receive

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

Study groups in NCT01893268
Study groupRoleWhat they receive
CohortNot described

What is being measured

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

  1. Proportion of patients treated with a chemotherapy in combination with Avastin including description of chemotherapy regimens and management of Avastin treatment

    Measured: Approximately 4 years

Secondary outcomes (7)

  1. Characteristics of patients with advanced non-squamous non-small cell lung cancer

    Measured: Approximately 4 years

  2. Tumor characteristics of patients with advanced non-squamous non-small cell lung cancer

    Measured: Approximately 4 years

  3. Progression-free survival

    Measured: Approximately 4 years

  4. Overall survival

    Measured: Approximately 4 years

  5. Quality of Life

    Measured: Approximately 4 years

  6. Safety: Incidence of adverse events

    Measured: Approximately 4 years

  7. Reasons of non-use of Avastin as first-line therapy

    Measured: Approximately 4 years

Timeline

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

  1. First posted8 Jul 2013 (estimated)
  2. Study start25 Jul 2013
  3. Primary completion20 Mar 2018
  4. Study completion20 Mar 2018

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
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01893268
Sponsor's protocol ID
ML28621
Status last verified
May 2018
First submitted
2 Jul 2013
Last updated
14 May 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 88 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 3 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 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of patients treated with a chemotherapy in combination with Avastin including description of chemotherapy regimens and management of Avastin treatment (time frame: Approximately 4 years). 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 NCT01893268.

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 14 May 2018.

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