Post-Surgical Non-Small Cell Lung Cancer (NSCLC) Follow-up
August 9, 2022 updated by: Intergroupe Francophone de Cancerologie Thoracique
Multicentric Randomized Phase III Study of Post-Surgical NSCLC Follow-up
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1775
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Belfort, France, 90016
- Centre Hospitalier - Pneumologie
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Besancon, France, 25000
- CHU Besancon - Pneumologie
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Caen, France, 14000
- Centre F. Baclesse
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Caen, France, 14000
- CHU - Pneumologie
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Grenoble, France, 38000
- CHU Grenoble - pneumologie
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Saint-priest En Jarez, France, 42271
- Institut de Cancérologie de la Loire
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Strasbourg, France, 63000
- CHU Lyautey - Pneumologie
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Radiological arm (Clinical Visit + X-Ray Chest)
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Clinical Visit + X-Ray Chest
|
|
Experimental: 2
Scan ARM : Clinical Visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous type)
|
Clinical visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous cell)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Compare overall survival for each arm
Time Frame: 6-month
|
6-month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Virginie Westeel, Pr, Centre Hospitalier Universitaire de Besancon
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1016/s0761-8425(07)91135-3. French.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2005
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
July 1, 2022
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Actual)
August 10, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFCT-0302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.