Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

— OPERAGE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956331
• Other study ID #: GFPC 08-05
• Status: Completed
• Phase: N/A
• First received: September 29, 2013
• Last updated: October 6, 2013
• Start date: March 2009
• Est. completion date: June 2013

Study information

• Verified date: October 2013
• Source: Groupe Francais De Pneumo-Cancerologie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
France	Site 12	Aix En Provence
France	Centre Hospitalier Universitaire	Angers
France	Centre Hospitalier D Argenteuil	Argenteuil	Val D'oise
France	Centre Hospitalier du Morvan	Brest
France	Centre François Baclesse	Caen
France	Centre Hospitalier René Dubos	Cergy-pontoise
France	Site 30	Charleville Mezieres
France	Site 33	Creteil
France	Site 07	Draguignan
France	Site 32	Elbeuf
France	Site 04	GAP
France	Centre Hospitalier Les Oudairies	La Roche Sur Yon
France	Site 41	Le Chesnay
France	Hospital du Cluzeau	Limoges
France	Centre Hospitalier Régional	Longjumeau
France	Site 06	Marseille
France	Site 42	Orleans
France	Hospital Saint Antoine	Paris
France	Site 19	Perigueux
France	Site 20	Rennes
France	Site 17	Rouen
France	Site 18	Rouen
France	Hôpital Yves Le Foll	Saint Brieuc
France	Site 14	Toulon
France	Site 11	Villefranche Sur Saone

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Francais De Pneumo-Cancerologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative morbidity à 30-day	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.	March 2014	No
Secondary	Post operative mortality	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.	March 2014	No
Secondary	Length of post operative hospital stay	Length of post operative hospital stay : hospitalization duration : intensive care, surgery department evaluated at Day 10 and post operative visit Day 30.	March 2014	No
Secondary	Length of intensive care unit stay	Length of intensive care unit stay evaluated at Day 10 (hospital release)and post operative visit at Day 30	March 2014	No