Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer

Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer - A Prospective Observational Study in Elderly Patients With Non-small Cells Lung Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01956331

Acronym

OPERAGE

Enrollment

302

Registered

2013-10-08

Start date

2009-03-31

Completion date

2013-06-30

Last updated

2013-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

NSC lung Cancer,Elderly patients,post operative,

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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.
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

Countries

France

Outcome results