Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT01956331
• Lead Sponsor: Groupe Francais De Pneumo-Cancerologie

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.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-09-29
• Status Verified: 2013-10
• Study First Submitted QC: 2013-10-06
• Last Update Submitted: 2013-10-06
• Study First Posted: 2013-10-08
• Last Update Posted: 2013-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post operative morbidity à 30-day	March 2014	Post operative morbidity at 30-day : Post operative complications occurred during 30 days post surgery, evaluated with CTCAE V3.0. Complications grade 2.3.4 will be analyzed from day 1 up to day 30, collected at Day 1,Day 10, Day 30.; A data collection is scheduled at Day 90 for delayed complications.; Evaluation : preoperative at Day-30 up to Day 0, Postoperative at Day 10, day 30, Day 90, Day 360.

Secondary Outcome Measures

Name	Time	Method
Length of post operative hospital stay	March 2014	Length of post operative hospital stay : hospitalization duration : intensive care, surgery department evaluated at Day 10 and post operative visit Day 30.
Post operative mortality	March 2014	Post operative mortality : mortality from Day 1 to Day 30 and survival at Day 360.; Quality of life will be evaluated by : LCSS Spitzer index ADL,IADL.
Length of intensive care unit stay	March 2014	Length of intensive care unit stay evaluated at Day 10 (hospital release)and post operative visit at Day 30

Trial Locations

Locations (25)

Centre Hospitalier D Argenteuil; 🇫🇷 Argenteuil, Val D'oise, France

Centre Hospitalier René Dubos; 🇫🇷 Cergy-pontoise, France

Site 14; 🇫🇷 Toulon, France

Centre François Baclesse; 🇫🇷 Caen, France

Site 20; 🇫🇷 Rennes, France

Site 42; 🇫🇷 Orleans, France

Site 33; 🇫🇷 Creteil, France

Site 07; 🇫🇷 Draguignan, France

Hôpital Yves Le Foll; 🇫🇷 Saint Brieuc, France

Site 11; 🇫🇷 Villefranche Sur Saone, France

Centre Hospitalier Régional; 🇫🇷 Longjumeau, France

Site 12; 🇫🇷 Aix En Provence, France

Centre Hospitalier du Morvan; 🇫🇷 Brest, France

Site 30; 🇫🇷 Charleville Mezieres, France

Site 32; 🇫🇷 Elbeuf, France

Centre Hospitalier Les Oudairies; 🇫🇷 La Roche Sur Yon, France

Site 41; 🇫🇷 Le Chesnay, France

Site 04; 🇫🇷 GAP, France

Hospital du Cluzeau; 🇫🇷 Limoges, France

Hospital Saint Antoine; 🇫🇷 Paris, France

Site 06; 🇫🇷 Marseille, France

Site 19; 🇫🇷 Perigueux, France

Site 18; 🇫🇷 Rouen, France

Centre Hospitalier Universitaire; 🇫🇷 Angers, France

Site 17; 🇫🇷 Rouen, France