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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Centre Hospitalier Universitaire de Besancon
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT00198341
First received: September 12, 2005
Last updated: April 29, 2013
Last verified: April 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1744
Study Start Date: January 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 12, 2005
Last Updated: April 29, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on September 18, 2014