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The objective of the study is to prospectively generate real-life data in patients aged ≥70 years treated in first line for a thoracic tumor (Non-Small-Cell Lung Carcinoma) according to best standard of care as defined by the European Society for Medical Oncology (ESMO). This cohort will aim to:
At the same time, exploratory sub-cohorts will be identified including participants treated uniformly with the same molecule, and/or the same innovative strategy.
Participants will be followed in accordance with investigator's usual clinical practice at the corresponding site. They will be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real world cohort of NSCLC older adults patients | Other | Cohort of patients ≥70 years of age with NSCLC treated in first line therapy for thoracic tumors according to ESMO-referenced therapeutic standards or according to an innovative molecule and/or strategy. An optional biobank based on blood samples taken during the screening phase prior to the first administration of systemic treatment will be collected. Sampling of tumoral materials will be collected prior to study participation and send for central reading. Patients will be asked to come at the hospital for their regular visits as per site current practice and to complete three quality of life questionnaires (EORTC QLQ-F17; QLQ-LC13; QLQ-ELD14). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-bank repository | Genetic | Blood samples taken during the screening phase prior to the first administration of systemic treatment and stored in a repository for a maximum duration of 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | The Progression Free Survival is defined as the time between treatment start date and event date defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first. Disease progression will be evaluated according to (RECIST) 1.1 assessed locally. Frequency of this assessment is let to the investigator 's discretion and local practices. The participants will be followed until disease progression or death for any cause. Patients without an event at the time of analysis will be censored at the date of their last tumor assessment. | From the date of first dose of treatment received until the date of the first documented disease progression according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 or to death from any cause, whichever comes first, assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The objective response rate (ORR) is defined as the proportion of patients with complete response (CR) or partial response (PR) as the best response during the study according to RECIST 1.1 criteria based on tumoral assessment performed by thorax-abdominal-pelvic and brain CT scans. The frequency of the tumor assessments will follow the site practices. | From the date of first dose of treatment received until the date of the first documented disease progression according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 or to death from any cause, whichever comes first, assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Biobank sampling | Blood samples will be collected at inclusion, before the first administration of NSCLC therapy, for exploratory analyses in ancillary studies | At inclusion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Romain CORRE, Medical Doctor | Contact | +330298526404 | romain.corre@ch-cornouaille.fr | |
| Soizic FERLANDIN | Contact | +330663224789 | soizic_ferlandin@yahoo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Laurent GREILLIER, Professor | Groupe Français de Pneumo-Cancérologie (GFPC) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH du Pays d Aix | Recruiting | Aix-en-Provence | 13616 | France |
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| Quality of Life (QoL) | Other | Collection of EORTC QoL questionnaires QLQ-F17, QLQ-LC13 and QLQ-ELD14:
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| G-Code | Procedure | G-CODE: Katz Autonomy Scale (ADL), Instrumental Activities of Daily Living questionnaire (IADL), Charlson score, mini GDS, mini COG, falls history, Timed Get Up and Go test, social environment. |
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| Overall Survival (OS) | Overall survival (OS) is calculated as the time between the date of treatment initiation and date of death, and censored at date of last news for patients alive at the end of the study. | From the treatment start date up to the date of death for a 2-year-period maximum |
| Duration of Response (DOR) | The duration of response is defined as the time between the date of the first response assessed by RECIST 1.1 to the date of progression or death for any cause, whichever comes first, and censored at the date of last tumor evaluation for patients still responding to treatment at the end of the study (after 2 years). | From the date of the first response to the date of progression or death, whichever comes first, or for a 2-year-period maximum |
| Time to Response (TTR) | Time to response is measured from the date of treatment initiation to the date of first response as defined by RECIST 1.1. | From the start date of treatment up to the date of first response or for a 2-year-period maximum |
| Treatment Duration | The duration of treatment is defined as the time between the treatment start date and the date of definitive cessation of treatment, whatever the cause. | From the treatment start date and the treatment stop date whatever the cause up to a 2-year-period maximum. |
| Safety events | All adverse events experienced by the participants, whatever the grades of toxicity, will be collected according to CTCAE v4.0 (common terminology criteria for adverse events). | From the enrollment up to the participants study end date or for a 2-year-period maximum |
| Treatments description | The treatments for NSCLC will be described including the adaptations: discontinuations, treatment interruptions, dose adaptations. The reasons for the changes will be recorded. | From the start date of the NSCLC treatment up to the participant study end date or for a 2-year-period maximum |
| Geriatric interventions: specialized consultations | The specialized geriatric consultations carried out to correct frailties will be collected during the study participation including psychological and/or dietetic consultations. | From the enrollment up to the participant study end date or for a 2-year-period maximum |
| Geriatric interventions: specialized exercises | The specialized geriatric exercises carried out to correct frailties will be collected during the study participation including prescription of adapted physical activity and/or cognitive stimulation exercises. | From the enrollment up to the participant study end date or for a 2-year-period maximum |
| Geriatric interventions: specialized help at home | The specialized geriatric interventions at home carried out to correct frailties will be collected during the study participation including home visits by a nurse or home help. | From the enrollment up to the participant study end date or for a 2-year-period maximum |
| Geriatric interventions: specialized medications | The specialized geriatric medications carried out to correct frailties will be collected during the study participation. | From the enrollment up to the participant study end date or for a 2-year-period maximum |
| European Organisation for Research and Treatment of Cancer Core Function Questionnaire (QLQ-F17) | The QLQ-F17 is a validated cancer-specific questionnaire specific to cancer. It includes 17 items to assess 6 QoL scales: 1 global health scale and 5 functional scales (physical, role,emotional, cognitive, social). This is a shortened version of the QLQ-C30, containing only the functional and overall quality of life sections. This questionnaire was developed by the EORTC in order to optimize the collection of quality-of-life data, and to avoid overloading the patient with a lengthy questionnaire. Symptoms will be assessed via modules. A score is generated for each dimension and standardized on a scale from 0 to 100, so that a high score reflects a high overall health status, a high functional level and a high symptomatic level. According to EORTC recommendations, the score can be calculated if at least 50% of the items in the corresponding dimension have been completed. Otherwise, the score will be considered missing. | At enrolment, at 12 weeks, at 6 months and at 12 months. |
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-ELDerly 14 (QLQ-ELD14) | The QLQ-ELD14 questionnaire is specific to elderly cancer patients. It contains 14 items measuring 7 dimensions of quality of life : two functional dimensions (maintaining a positive positive vision/motivation, family support) and 5 symptomatic dimensions (mobility, worries about others, worries about the future, disease burden, joint problems). All of the scales and single-item range in score from 0-100. A score is generated for each dimension, so that a high score reflects a high functional level (for the scales concerned), and a high symptomatic level (for the scales concerned). | At enrolment, at 12 weeks, at 6 months and at 12 months |
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) | The QLQ-LC13 is a lung cancer-specific questionnaire containing 13 items to assess symptoms specific to lung cancer and its treatment: dyspnea, cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm or shoulder pain or shoulder pain, pain in other parts, anti-inflammatory drugs, drugs for pain. A score is generated per dimension so that a high score reflects a high symptomatic level. All of the scales and single-item range in score from 0-100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status represents a high quality of life, but a high score for symptom scale/item represents a high level of symptomatology/problems. | At enrolment, at 12 weeks, at 6 months and at 12 months |
| Geriatric characteristics G8 score | The following geriatric characteristics will be collected is available in the participant medical file: G8 score. The total G-8 score lies between 0 and 17. A higher score indicates a better health status. | At enrollment and at disease progression for a maximum of 2-year-period. |
| Geriatric characteristics Geriatric Core DatasEt (G-CODE) | The following geriatric characteristics will be collected is available in the participant medical file: Geriatric Core DatasEt (G-CODE). G-CODE is a core set of geriatric data. It has ten tools/items and a median completion time of 9 min. It includes Katz autonomy scale (ADL), Instrumental Activities of Daily Living (IADL), Charlson score, mini Geriatric Depression Sale (mini-GDS), short cognitive impairment screening exam (mini COG), falls history, Timed Get Up and Go test, social environment. The G-CODE allows for a minimal geriatric description of the older cancer population and standardisation of geriatric data, enabling comparison across trials. | At enrollment and at disease progression for a maximum of 2-year-period. |
| Hôpital Henri Duffaut | Recruiting | Avignon | 84000 | France |
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| Institut du Cancer d'Avignon | Recruiting | Avignon | 84918 | France |
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| CH Bastia | Not yet recruiting | Bastia | 20600 | France |
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| Oncologie Thoracique Hôpital Morvan | Recruiting | Brest | 29200 | France |
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| Pneumologie Centre François Baclesse | Not yet recruiting | Caen | 14000 | France |
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| CH Métropole-Savoie | Recruiting | Chambéry | 73000 | France |
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| Centre Hospitalier du Cotentin | Recruiting | Cherbourg | 50102 | France |
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| CHU Hôpital Montpied | Not yet recruiting | Clermont-Ferrand | 63000 | France |
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| Pneumologie Hospices Civils de Colmar | Recruiting | Colmar | 68024 | France |
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| Pneumologie CHI Creteil | Recruiting | Créteil | 94010 | France |
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| CH Elbeuf | Recruiting | Elbeuf | 76503 | France |
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| Polyclinique de Blois | Not yet recruiting | La Chaussée-Saint-Victor | 41260 | France |
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| CHD Les Oudairies | Recruiting | La Roche-sur-Yon | 85000 | France |
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| CH La Rochelle | Recruiting | La Rochelle | 17000 | France |
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| Hôpital A. Mignot | Recruiting | Le Chesnay | 78157 | France |
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| Hôpital Robert Boulin | Recruiting | Libourne | 33505 | France |
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| CHU Dupuytren | Recruiting | Limoges | 87042 | France |
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| Hôpital de la Vallée - Service Pneumologie | Recruiting | Longjumeau | 91160 | France |
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| Centre Léon Bérard | Recruiting | Lyon | 69373 | France |
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| Hôpital Européen de Marseille | Recruiting | Marseille | 13003 | France |
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| Oncologie Thoracique Hôpital Nord | Recruiting | Marseille | 13915 | France |
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| GHEF Site de Meaux | Recruiting | Meaux | 77100 | France |
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| Centre d Oncologie de Gentilly | Recruiting | Nancy | 54000 | France |
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| Pneumologie CHR | Recruiting | Orléans | 45067 | France |
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| Pneumologie Hôpital Cochin | Not yet recruiting | Paris | 75014 | France |
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| Pneumologie Hôpital Tenon | Not yet recruiting | Paris | 75970 | France |
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| Cantre Catalan d Oncologie | Not yet recruiting | Perpignan | 66000 | France |
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| CH Annecy Genevois | Recruiting | Pringy | 74374 | France |
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| Pneumologie CHI Quimper | Recruiting | Quimper | 29000 | France |
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| CHU Hôpital Ponchailloux | Recruiting | Rennes | 35033 | France |
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| Pneumologie Hôpital Charles Nicolle | Not yet recruiting | Rouen | 76031 | France |
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| Pneumologie CHU Felix Guyon | Recruiting | Saint-Denis | 97400 | France |
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| Pneumologie CHU St Etienne | Recruiting | Saint-Etienne | 42270 | France |
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| Clinique Mutualiste | Recruiting | Saint-Nazaire | 44600 | France |
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| CHU de la Réunion | Recruiting | Saint-Pierre | 97410 | France |
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| CLCC Paul Strauss | Recruiting | Strasbourg | 67000 | France |
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| Hôpital d'Instruction des Armées Saint-Anne | Recruiting | Toulon | 83041 | France |
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| CHITS Toulon Sainte Musse | Recruiting | Toulon | 83056 | France |
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| Oncologie CHBA | Recruiting | Vannes | 56000 | France |
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| Hôpital Nord OUest | Recruiting | Villefranche-sur-Saône | 69655 | France |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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