Clinical trial NCT01956331: Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer
Official title: Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer - A Prospective Observational Study in Elderly Patients With Non-small Cells Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: NSC lung Cancer,Elderly patients,post operative,
Lead sponsor: Groupe Francais De Pneumo-Cancerologie
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 302
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients aged 70 years and more with Non Small Cell lung Cancer.

Brief summary: schema : Prospective prognostic study The main objective is to study the value of the Comprehensive Geriatric Assessment in predicting the risk of post operative complications after lung resection for cancer.

Detailed description: Primary outcome :

Post-operative morbidity at 30-day :

Post operative complications occurred during 30 days post surgery, evaluated with CTCAE V3.0, and Complications grade 2.3.4 will be analyzed from day 1, at day 20 up to day 30.

Evaluation :

Pre operative : Day -30 to Day 0, Post operative : Day 10, Day 30, Day 90, Day 360.

Secondary outcome :

Post-operative mortality, Length of post operative hospital stay, Length of intensive care unit stay, QOL assessment, One year survival.

Eligibility criteria: Inclusion Criteria:

* Patient 70 years and more
* Lung tumour of clinical staging I to IIIB receiving curative lung resection

Exclusion Criteria:

* Diagnosis of non small lung cancer invalidated by the histological findings of the operative sample
* psychological conditions, social support or geographical conditions not allowing the study follow up
* Pre operative chemotherapy or radiotherapy

Primary outcomes:
measure: Post operative morbidity à 30-day
timeFrame: March 2014
Secondary outcomes:
measure: Post operative mortality
timeFrame: March 2014
measure: Length of post operative hospital stay
timeFrame: March 2014
measure: Length of intensive care unit stay
timeFrame: March 2014
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Centre Hospitalier D Argenteuil
state: Val D'oise
city: Aix En Provence
country: France
facility: Site 12
city: Angers
country: France
facility: Centre Hospitalier Universitaire
city: Brest
country: France
facility: Centre Hospitalier du Morvan
city: Caen
country: France
facility: Centre François Baclesse
city: Cergy-pontoise
country: France
facility: Centre Hospitalier René Dubos
city: Charleville Mezieres
country: France
facility: Site 30
city: Creteil
country: France
facility: Site 33
city: Draguignan
country: France
facility: Site 07
city: Elbeuf
country: France
facility: Site 32
city: GAP
country: France
facility: Site 04
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Les Oudairies
city: Le Chesnay
country: France
facility: Site 41
city: Limoges
country: France
facility: Hospital du Cluzeau
city: Longjumeau
country: France
facility: Centre Hospitalier Régional
city: Marseille
country: France
facility: Site 06
city: Orleans
country: France
facility: Site 42
city: Paris
country: France
facility: Hospital Saint Antoine
city: Perigueux
country: France
facility: Site 19
city: Rennes
country: France
facility: Site 20
city: Rouen
country: France
facility: Site 18
city: Rouen
country: France
facility: Site 17
city: Saint Brieuc
country: France
facility: Hôpital Yves Le Foll
city: Toulon
country: France
facility: Site 14
city: Villefranche Sur Saone
country: France
facility: Site 11
Study officials:
affiliation: HOPITAL DE DRAGUIGNAN - SERVICE DE PNEUMOLOGIE
name: LECAER HERVE, MD
role: STUDY_DIRECTOR
affiliation: HOPITAL INTERCOMMUNAL DE CRETEIL SERVICE DE PNEUMOLOGIE
name: CHOUAID CHRISTOS, PR
role: STUDY_DIRECTOR
affiliation: CENTRE HOSPITALIER D'ARGENTEUIL
name: RAYNAUD Christine, MD
role: PRINCIPAL_INVESTIGATOR
References: