Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer

N/ACompletedNCT01956331

Groupe Francais De Pneumo-Cancerologie302 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

302

Conditions

Carcinoma, Non-Small-Cell Lung

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (25)

Centre Hospitalier D Argenteuil

Argenteuil, Val D'oise, France

Site 12

Aix-en-Provence, France

Outcomes

Primary Outcomes

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.

Time frame: March 2014

Secondary Outcomes

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.

Time frame: March 2014

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.

Time frame: March 2014

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

Time frame: March 2014

Data from ClinicalTrials.gov

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