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Post-Surgical Non-Small Cell Lung Cancer (NSCLC) Follow-up

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ClinicalTrials.gov Identifier: NCT00198341
Recruitment Status : Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : April 25, 2018
Sponsor:
Collaborator:
Centre Hospitalier Universitaire de Besancon
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

Brief Summary:
The follow-up of patients operated on for lung cancer is heterogeneous. An intensive follow-up including routine clinic visits, chest X-rays, chest computed tomography (CT) scans and fiberoptic bronchoscopies might detect more small, potentially curable, recurrences and second cancers. However, as it appears in the American Society of Clinical Oncology (ASCO) recommendations, a large randomized study is necessary to evaluate the survival impact of such a follow-up strategy. This is the main objective of this IFCT-0302 study, which is a large randomized controlled study conducted in France comparing this intensive follow-up to a follow-up with only routine clinic visits and chest X-rays.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Procedure: Radiological Arm Procedure: Scannographic arm Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1744 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentric Randomized Phase III Study of Post-Surgical NSCLC Follow-up
Study Start Date : January 2005
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 1
Radiological arm (Clinical Visit + X-Ray Chest)
Procedure: Radiological Arm
Clinical Visit + X-Ray Chest

Experimental: 2
Scan ARM : Clinical Visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous type)
Procedure: Scannographic arm
Clinical visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous cell)




Primary Outcome Measures :
  1. Compare overall survival for each arm [ Time Frame: 6-month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • completely resected stage I, II, IIIa, and T4 due to satellite tumor nodule(s) N0-2 NSCLC

Exclusion Criteria:

  • stage IIIb to IV NSCLC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198341


Locations
France
Centre Hospitalier - Pneumologie
Belfort, France, 90016
CHU Besancon - Pneumologie
Besancon, France, 25000
Centre F. Baclesse
Caen, France, 14000
CHU - Pneumologie
Caen, France, 14000
CHU Grenoble - pneumologie
Grenoble, France, 38000
Institut de Cancérologie de la Loire
Saint-priest En Jarez, France, 42271
CHU Lyautey - Pneumologie
Strasbourg, France, 63000
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: Virginie Westeel, Pr Centre Hospitalier Universitaire de Besancon

Additional Information:
Publications:
Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT00198341     History of Changes
Other Study ID Numbers: IFCT-0302
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
Post-surgical Non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases