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

This study is currently recruiting participants.

Verified September 2011 by Intergroupe Francophone de Cancerologie Thoracique

First Received on September 12, 2005. Last Updated on September 5, 2011 History of Changes

Sponsor:	Intergroupe Francophone de Cancerologie Thoracique
Collaborator:	Centre Hospitalier Universitaire de Besancon
Information provided by:	Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:	NCT00198341

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 III

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:

MedlinePlus related topics: CT Scans Cancer Lung Cancer Nuclear Scans X-Rays

U.S. FDA Resources

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 2013
Estimated Primary Completion Date:	December 2012 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198341

Contacts

Contact: Virginie Westeel, Pr	+33 3 81 66 88 04	virginie.westeel@univ-fcomte.fr
Contact: Franck Morin	+33 1 56 81 10 45	contact@ifct.fr

Locations

France
Centre Hospitalier - Pneumologie	Recruiting
Belfort, France, 90016
Contact: Jean-Luc Breton, Dr +33 3 84 98 51 18
CHU Besancon - Pneumologie	Recruiting
Besancon, France, 25000
Contact: Virginie Westeel, Pr
Centre F. Baclesse	Recruiting
Caen, France, 14000
Contact: Radj Gervais, Pr
Principal Investigator: Radj Gervais, Dr
CHU - Pneumologie	Recruiting
Caen, France, 14000
Contact: Gerard Zalcman, Pr
Principal Investigator: Gerard Zalcman, Pr
CHU Grenoble - pneumologie	Recruiting
Grenoble, France, 38000
Contact: Denis Moro-Sibilot, Pr DMoro-Sibilot@chu-grenoble.fr
Principal Investigator: Denis Moro-Sibilot, Pr
Institut de Cancérologie de la Loire	Recruiting
Saint-priest En Jarez, France, 42271
Contact: Pierre Fournel, Dr
Principal Investigator: Pierre Fournel, Dr
CHU Lyautey - Pneumologie	Recruiting
Strasbourg, France, 63000
Contact: Elisabeth Quoix, Pr
Principal Investigator: Elisabeth Quoix, Pr

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:

official IFCT website This link exits the ClinicalTrials.gov site

Publications:

Westeel V, Lebitasy MP, Mercier M, Girard P, Barlesi F, Blanchon F, Tredaniel J, Bonnette P, Woronoff-Lemsi MC, Breton JL, Azarian R, Falcoz PE, Friard S, Geriniere L, Laporte S, Lemarie E, Quoix E, Zalcman G, Guigay J, Morin F, Milleron B, Depierre A; Intergroupe Francophone de Cancerologie Thoracique (IFCT). [IFCT-0302 trial: randomised study comparing two follow-up schedules in completely resected non-small cell lung cancer] Rev Mal Respir. 2007 May;24(5):645-52. French.

Responsible Party:	Pr Virginie Westeel, CHU Besançon
ClinicalTrials.gov Identifier:	NCT00198341 History of Changes
Other Study ID Numbers:	IFCT-0302
Study First Received:	September 12, 2005
Last Updated:	September 5, 2011
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
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic

Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012