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

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

This study is currently recruiting participants.
Verified by Intergroupe Francophone de Cancerologie Thoracique, March 2008

Sponsors and Collaborators:	Intergroupe Francophone de Cancerologie Thoracique 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

MedlinePlus related topics:

Cancer Lung Cancer X-Rays

Drug Information available for:

X-Rays

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Multicentric Randomized Phase III Study of Post-Surgical NSCLC Follow-up

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
1: Experimental Radiological arm (Clinical Visit + X-Ray Chest)	Procedure: Radiological Arm Clinical Visit + X-Ray Chest
2: Experimental 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	franck.morin@ifct.fr

Locations


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

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:	CHU Besançon ( Pr Virginie Westeel )
Study ID Numbers:	IFCT-0302
First Received:	September 12, 2005
Last Updated:	March 30, 2008
ClinicalTrials.gov Identifier:	NCT00198341
Health Authority:	France: Ministry of Health