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NCT00198341 Clinical Trial

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

Non-Small-Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00198341
Other study ID # IFCT-0302
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2005
Est. completion date July 2022

Study information
Verified date August 2022
Source Intergroupe Francophone de Cancerologie Thoracique
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1775
Est. completion date July 2022
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Radiological Arm
Clinical Visit + X-Ray Chest
• Scannographic arm
Clinical visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous cell)

Locations
Country Name City State
France Centre Hospitalier - Pneumologie Belfort
France CHU Besancon - Pneumologie Besancon
France Centre F. Baclesse Caen
France CHU - Pneumologie Caen
France CHU Grenoble - pneumologie Grenoble
France Institut de Cancérologie de la Loire Saint-priest En Jarez
France CHU Lyautey - Pneumologie Strasbourg

Sponsors (2)
Lead Sponsor Collaborator
Intergroupe Francophone de Cancerologie Thoracique Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Compare overall survival for each arm 6-month
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