Non-Squamous Non-Small Cell Lung Cancer Clinical Trial
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.
| NCT number | NCT01893268 |
| Other study ID # | ML28621 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 25, 2013 |
| Est. completion date | March 20, 2018 |
| Verified date | May 2018 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 279 |
| Est. completion date | March 20, 2018 |
| Est. primary completion date | March 20, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Clinique Du Docteur Calabet; Cromg | Agen | |
| France | Ch Du Pays D Aix; Pneumologie | Aix En Provence | |
| France | Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire | Aix En Provence | |
| France | Cabinet Medical | Amiens | |
| France | Centre Hospitalier Uni Ire; Pneumology | Angers | |
| France | Chic Cote Basque Bayonne; Pneumologie | Bayonne | |
| France | HOPITAL JEAN MINJOZ; Oncologie | Besancon | |
| France | CH Germon ET Gauthier; Pneumologie | Beuvry | |
| France | Ch De Beziers; Pneumologie | Beziers | |
| France | Hopital Avicenne; Cancerologie | Bobigny | |
| France | Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie | Bordeaux | |
| France | Centre Hospitalier Fleyriat; Oncologie/Hematologie | Bourg En Bresse | |
| France | Ch De Fleyriat; Pneumologie 1 | Bourg En Bresse | |
| France | Hia Clermont Tonnerre; Pneumologie | Brest | |
| France | Ch De Brive La Gaillarde; Radiotherapie Oncologie | Brive La Gaillarde | |
| France | Hopital Louis Pradel; Pneumologie | Bron | |
| France | Hopital Pierre Nouveau; Pneumologie | Cannes | |
| France | Ch Antoine Gayraud; Oncologie | Carcassonne | |
| France | Clinique Du Parc; Hematologie | Castelnau Lez | |
| France | Ctre Medical Nicolas de Pontoux | Chalon Sur Saone | |
| France | Ch De Chauny; Pneumologie | Chauny | |
| France | CH Du Cotentin Site De Cherbourg; Hopital De Jour | Cherbourg Octeville | |
| France | Centre Jean Perrin; Hopital De Semaine | Clermont-Ferrand | |
| France | Hopital Gabriel Montpied; Service de Pneumologie | Clermont-ferrand | |
| France | Hopital Louis Pasteur; Pneumologie Tabacologie | Colmar | |
| France | Centre Hospitalier Alpes Leman CHAL;Pneumologie | Contamine Sur Arve | |
| France | Clinique Des Cedres; Pneumologie | Cornebarrieu | |
| France | Centre Hospitalier Intercommunal; Service de Pneumologie | Creteil | |
| France | Chu Site Du Bocage;Pneumologie | Dijon | |
| France | Ch De La Dracenie; Pneumologie | Draguignan | |
| France | Centre D Oncologie Dunkerquois | Dunkerque | |
| France | Chi Emile Durkheim Site Epinal; Pneumologie | Epinal | |
| France | Chi Alpes Du Sud Site De Gap; Pneumologie | GAP | |
| France | Hopital Nord Ouest;Unite 2c | Gleize | |
| France | CH Emmanuel Rain; Oncologie | Gonesse | |
| France | Hopital Prive De Chantilly; Medecine | Gouvieux Chantilly | |
| France | Hopital D Hayange;Medecine A Et P | Hyeres | |
| France | Centre Oscar Lambret; Chir Cancerologie General | Lille | |
| France | Hopital Calmette; Pneumologie Oncologie Ouest | Lille | |
| France | Hopital Saint Vincent; Consult et Explorations | Lille | |
| France | Clinique Chenieux; Oncology | Limoges | |
| France | Hopital Du Cluzeau; Service de Pathologie Respiratoire | Limoges | |
| France | Hopital Dupuytren; Pneumologie | Limoges | |
| France | Centre Hospitalier Général; Pneumologie | Longjumeau | |
| France | Ch Bretagne Sud Site Scorff; Oncologie Medicale | Lorient | |
| France | Centre Medical Parot | Lyon | |
| France | Centre Hospitalier François Quesnay; Pneumologie-Neurologie | Mantes La Jolie | |
| France | Hôpital Saint Joseph; Oncologie Medicale | Marseille | |
| France | Centre Hospitalier; Pneumologie | Metz Tessy | |
| France | Hopital Layne; Medecine Ambulatoire | Mont-de-marsan | |
| France | Ch De Montauban; Pneumologie | Montauban | |
| France | Hopital Emile Muller;Pneumologie | Mulhouse | |
| France | Cabinet Medical | Nancy | |
| France | Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE | Nancy | |
| France | Hopital Caremeau; Pneumologie | Nimes | |
| France | Clinique sainte marie; chimiotherapie ambulatoire | Osny | |
| France | Hopital Cochin; Unite Fonctionnelle D Oncologie | Paris | |
| France | Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale | Paris | |
| France | Hopital Saint Louis; Oncologie Medicale | Paris | |
| France | Centre Catalan D' Oncologie | Perpignan | |
| France | Centre Hospitalier Lyon Sud; Pneumologie | Pierre Benite | |
| France | CH Rene Dubos; Oncologie | Pontoise | |
| France | Hopital Laennec; Service de Pneumologie | Quimper | |
| France | Ch De Rambouillet; Pneumologie Cardiologie | Rambouillet | |
| France | Cabinet | Reims | |
| France | Hopital de Pontchaillou; Service de Pneumologie | Rennes | |
| France | Clinique Saint Hilaire; Sce Chimiotherapie | Rouen | |
| France | Centre Cardiologique Du Nord; Pneumologie | Saint Denis | |
| France | Clinique de L'Union; Oncologie | Saint Jean | |
| France | Cabinet Medical | Saint Laurent Du Var | |
| France | Hopital Nord; Service de Pneumologie | Saint Priest En Jarez | |
| France | Ch De Saintonge; Unite 2 Pneumologie | Saintes | |
| France | Ch De Saint Quentin; Medecine B14 | St Quentin | |
| France | Centre Medical National Mgen; Pneumologie | Ste Feyre | |
| France | Centre Paul Strauss; Oncologie Medicale | Strasbourg | |
| France | Hopital Bel Air; Pneumologie Allergologie | Thionville | |
| France | Hopitaux Du Leman Site Thonon; Pneumologie | Thonon-les-bains | |
| France | Hia Sainte Anne; Pneumologie | Toulon | |
| France | Hopital Sainte Musse; Pneumologie | Toulon | |
| France | Clinique Pasteur; Pneumologie | Toulouse | |
| France | Groupe Oncorad Garonne; Unite Onco Hematologie | Toulouse | |
| France | Cabinet Medical | Tours | |
| France | Hopital Des Hauts Clos; Pneumologie | Troyes | |
| France | Ch De Valence; Medecine 7 | Valence | |
| France | Centre Alexis Vautrin; Oncologie Medicale | Vandoeuvre Les Nancy | |
| France | Hopital Robert Schuman; Pneumologie | Vantoux | |
| France | Gh Mutualiste Les Portes Du Sud; Pneumologie | Venissieux | |
| France | Hopital Saint Nicolas; Pneumologie | Verdun |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients treated with a chemotherapy in combination with Avastin including description of chemotherapy regimens and management of Avastin treatment | Approximately 4 years | ||
| Secondary | Characteristics of patients with advanced non-squamous non-small cell lung cancer | Approximately 4 years | ||
| Secondary | Tumor characteristics of patients with advanced non-squamous non-small cell lung cancer | Approximately 4 years | ||
| Secondary | Progression-free survival | Approximately 4 years | ||
| Secondary | Overall survival | Approximately 4 years | ||
| Secondary | Quality of Life | Approximately 4 years | ||
| Secondary | Safety: Incidence of adverse events | Approximately 4 years | ||
| Secondary | Reasons of non-use of Avastin as first-line therapy | Approximately 4 years |
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