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Completed

NCT Number: NCT01956331

Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier D Argenteuil, Argenteuil, Val D'oise, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Post operative mortality

    Time frame: 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.

  2. Length of post operative hospital stay

    Time frame: March 2014

    Length of post operative hospital stay : hospitalization duration : intensive care, surgery department evaluated at Day 10 and post operative visit Day 30.

  3. Length of intensive care unit stay

    Time frame: March 2014

    Length of intensive care unit stay evaluated at Day 10 (hospital release)and post operative visit at Day 30

Sponsors and collaborators

Lead sponsor

Groupe Francais De Pneumo-Cancerologie

Other

Registry information

Official study 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

Acronym: OPERAGE

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2013
Registry last updated
Oct 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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