Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer - A Prospective Observational Study in Elderly Patients With Non-small Cells Lung Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Groupe Francais De Pneumo-Cancerologie
- Enrollment
- 302
- Locations
- 25
- Primary Endpoint
- Post operative morbidity à 30-day
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Post operative morbidity à 30-day
Time Frame: 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 Outcomes
- Length of post operative hospital stay(March 2014)
- Post operative mortality(March 2014)
- Length of intensive care unit stay(March 2014)