PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies
- Conditions
- Non Small Cell Lung CancerLung Cancer
- Registration Number
- NCT06646471
- Lead Sponsor
- Groupe Francais De Pneumo-Cancerologie
- Brief Summary
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:
* characterize participants in terms of geriatrics, biology and carcinology
* describe the treatment modalities by stage, as well as the results in terms of efficacy, safety and impact on quality of life.
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:
* visit the clinic as per physician's request for checkups and tests for assessing general condition and clinical efficacy and tolerance of current treatment.
* perform the necessary regular para-clinical examinations (lab testing, imaging, re-biopsy).
* provide blood samples for bio-bank repository
* perform assessments specific to older adults
* answer three quality of life questionnaires
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Patient ≥70 years
- Non-small-cell lung cancer for which the multidisciplinary consultation required systemic treatment regardless of Tumor-Node-Metastasis (TNM) stage
- Patient naïve to systemic anticancer treatment for bronchial neoplasia
- Patient covered by social security
- Patient eligible for systemic treatment
- Systemic treatment with marketing authorization in the indication, available in routine care early access or compassionate access.
- Patient able to understand the protocol
- Patient not opposed to the collection of data concerning him/her
- Signature of study consent form.
- Patients under guardians or curators
- Patient not under the care of the investigating center and not monitored by the investigating center
- Patient already treated with systemic therapy for NSCLC
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) 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 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.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) 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 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.
Overall Survival (OS) From the treatment start date up to the date of death for a 2-year-period maximum 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.
Duration of Response (DOR) From the date of the first response to the date of progression or death, whichever comes first, or for a 2-year-period maximum 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).
Time to Response (TTR) From the start date of treatment up to the date of first response or for a 2-year-period maximum Time to response is measured from the date of treatment initiation to the date of first response as defined by RECIST 1.1.
Treatment Duration From the treatment start date and the treatment stop date whatever the cause up to a 2-year-period maximum. 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.
Safety events From the enrollment up to the participants study end date or for a 2-year-period maximum 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).
Treatments description From the start date of the NSCLC treatment up to the participant study end date or for a 2-year-period maximum The treatments for NSCLC will be described including the adaptations: discontinuations, treatment interruptions, dose adaptations. The reasons for the changes will be recorded.
Geriatric interventions: specialized consultations From the enrollment up to the participant study end date or for a 2-year-period maximum The specialized geriatric consultations carried out to correct frailties will be collected during the study participation including psychological and/or dietetic consultations.
Geriatric interventions: specialized exercises From the enrollment up to the participant study end date or for a 2-year-period maximum 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.
Geriatric interventions: specialized help at home From the enrollment up to the participant study end date or for a 2-year-period maximum 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.
Geriatric interventions: specialized medications From the enrollment up to the participant study end date or for a 2-year-period maximum The specialized geriatric medications carried out to correct frailties will be collected during the study participation.
European Organisation for Research and Treatment of Cancer Core Function Questionnaire (QLQ-F17) At enrolment, at 12 weeks, at 6 months and at 12 months. 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.European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-ELDerly 14 (QLQ-ELD14) At enrolment, at 12 weeks, at 6 months and at 12 months 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).European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) At enrolment, at 12 weeks, at 6 months and at 12 months 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.Geriatric characteristics G8 score At enrollment and at disease progression for a maximum of 2-year-period. 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.Geriatric characteristics Geriatric Core DatasEt (G-CODE) At enrollment and at disease progression for a maximum of 2-year-period. 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.
Trial Locations
- Locations (37)
CH du Pays d Aix
🇫🇷Aix En Provence, France
Hôpital Henri Duffaut
🇫🇷Avignon, France
CH Bastia
🇫🇷Bastia, France
Oncologie Thoracique Hôpital Morvan
🇫🇷Brest, France
Pneumologie Centre François Baclesse
🇫🇷Caen, France
CH Métropole-Savoie
🇫🇷Chambery, France
CHU Hôpital Montpied
🇫🇷Clermont-ferrand, France
Pneumologie Hospices Civils de Colmar
🇫🇷Colmar, France
Pneumologie CHI Creteil
🇫🇷Creteil, France
CH Elbeuf
🇫🇷Elbeuf, France
Polyclinique de Blois
🇫🇷La Chaussee Saint Victor, France
CHD Les Oudairies
🇫🇷La Roche Sur Yon, France
CH La Rochelle
🇫🇷La Rochelle, France
Hôpital A. Mignot
🇫🇷Le Chesnay, France
Hôpital Robert Boulin
🇫🇷Libourne, France
CHU Dupuytren
🇫🇷Limoges, France
Centre Léon Bérard
🇫🇷Lyon, France
Oncologie Thoracique Hôpital Nord
🇫🇷Marseille, France
GHEF Site de Meaux
🇫🇷Meaux, France
Centre d Oncologie de Gentilly
🇫🇷Nancy, France
Pneumologie CHR
🇫🇷Orleans, France
Pneumologie Hôpital Cochin
🇫🇷Paris, France
Pneumologie Hôpital Tenon
🇫🇷Paris, France
Cantre Catalan d Oncologie
🇫🇷Perpignan, France
CH Annecy Genevois
🇫🇷Pringy, France
Pneumologie CHI Quimper
🇫🇷Quimper, France
CHU Hôpital Ponchailloux
🇫🇷Rennes, France
Pneumologie Hôpital Charles Nicolle
🇫🇷Rouen, France
Pneumologie CHU Felix Guyon
🇫🇷Saint Denis, France
Clinique Mutualiste
🇫🇷Saint Nazaire, France
Pneumologie CHU St Etienne
🇫🇷Saint-etienne, France
CHU de la Réunion
🇫🇷Saint-pierre, France
CLCC Paul Strauss
🇫🇷Strasbourg, France
Hôpital d'Instruction des Armées Saint-Anne
🇫🇷Toulon, France
CHITS Toulon Sainte Musse
🇫🇷Toulon, France
Oncologie CHBA
🇫🇷Vannes, France
Hôpital Nord OUest
🇫🇷Villefranche Sur Saone, France