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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00198341
First Posted: September 20, 2005
Last Update Posted: March 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centre Hospitalier Universitaire de Besancon
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
  Purpose
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 Intervention Phase
Non-Small-Cell Lung Carcinoma Procedure: Radiological Arm Procedure: Scannographic arm Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

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

Estimated Enrollment: 1744
Study Start Date: January 2005
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Additional Information:
Publications:
Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT00198341     History of Changes
Other Study ID Numbers: IFCT-0302
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: March 10, 2016
Last Verified: March 2016

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