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

NCT ID: NCT00198341

Last Updated: 2022-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1775 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Small-Cell Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Radiological arm (Clinical Visit + X-Ray Chest)

Group Type EXPERIMENTAL

Radiological Arm

Intervention Type PROCEDURE

Clinical Visit + X-Ray Chest

2

Scan ARM : Clinical Visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous type)

Group Type EXPERIMENTAL

Scannographic arm

Intervention Type PROCEDURE

Clinical visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous cell)

Interventions

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Radiological Arm

Clinical Visit + X-Ray Chest

Intervention Type PROCEDURE

Scannographic arm

Clinical visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous cell)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role collaborator

Intergroupe Francophone de Cancerologie Thoracique

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Virginie Westeel, Pr

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Besancon

Locations

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Centre Hospitalier - Pneumologie

Belfort, , France

Site Status

CHU Besancon - Pneumologie

Besançon, , France

Site Status

Centre F. Baclesse

Caen, , France

Site Status

CHU - Pneumologie

Caen, , France

Site Status

CHU Grenoble - pneumologie

Grenoble, , France

Site Status

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, , France

Site Status

CHU Lyautey - Pneumologie

Strasbourg, , France

Site Status

Countries

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France

References

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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. doi: 10.1016/s0761-8425(07)91135-3. French.

Reference Type BACKGROUND
PMID: 17519819 (View on PubMed)

Westeel V, Foucher P, Scherpereel A, Domas J, Girard P, Tredaniel J, Wislez M, Dumont P, Quoix E, Raffy O, Braun D, Derollez M, Goupil F, Hermann J, Devin E, Barbieux H, Pichon E, Debieuvre D, Ozenne G, Muir JF, Dehette S, Virally J, Grivaux M, Lebargy F, Souquet PJ, Freijat FA, Girard N, Courau E, Azarian R, Farny M, Duhamel JP, Langlais A, Morin F, Milleron B, Zalcman G, Barlesi F. Chest CT scan plus x-ray versus chest x-ray for the follow-up of completely resected non-small-cell lung cancer (IFCT-0302): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Sep;23(9):1180-1188. doi: 10.1016/S1470-2045(22)00451-X. Epub 2022 Aug 11.

Reference Type DERIVED
PMID: 35964621 (View on PubMed)

Related Links

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http://www.ifct.fr

official IFCT website

Other Identifiers

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IFCT-0302

Identifier Type: -

Identifier Source: org_study_id

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