Non-Small-Cell Lung CarcinomaNCT00198341
Post-Surgical Non-Small Cell Lung Cancer (NSCLC) Follow-up
A study testing Radiological Arm and Scannographic arm in people with Non-Small-Cell Lung Carcinoma, run by Intergroupe Francophone de Cancerologie Thoracique at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- Radiological Arm and Scannographic arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,775 participants
- Where
- 7 sitesFrance
- Study dates
- Jan 2005to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- completely resected stage I, II, IIIa, and T4 due to satellite tumor nodule(s) N0-2 NSCLC
Who cannot join
- stage IIIb to IV NSCLC
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre Hospitalier - Pneumologie
Belfort, 90016
CHU Besancon - Pneumologie
Besançon, 25000
Centre F. Baclesse
Caen, 14000
CHU - Pneumologie
Caen, 14000
CHU Grenoble - pneumologie
Grenoble, 38000
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42271
CHU Lyautey - Pneumologie
Strasbourg, 63000
About this study
Official title: 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.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- Radiological Arm, Scannographic arm
- Keywords
- Post-surgical Non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiological ArmProcedure or surgery
Clinical Visit + X-Ray Chest
Scannographic armProcedure or surgery
Clinical visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous cell)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Radiological arm (Clinical Visit + X-Ray Chest) Receives: Procedure: Radiological Arm |
| 2 | Experimental | Scan ARM : Clinical Visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous type) Receives: Procedure: Scannographic arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare overall survival for each arm
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionMay 2018
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Small-Cell Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,775 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Besancon
- Responsible party
- Sponsor
- Investigators
- Virginie Westeel, Pr, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198341
- Sponsor's protocol ID
- IFCT-0302
- Status last verified
- Aug 2022
- First submitted
- 12 Sep 2005
- Last updated
- 10 Aug 2022
- Results posted
- No
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.
PubMed 17519819Westeel 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.
PubMed 35964621
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Randomized Phase III Study of Post-Surgical NSCLC Follow-up
- ClinicalTrials.gov ID
- NCT00198341
- Acronym / sponsor ID
- IFCT-0302
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- Post-surgical Non-small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,775 participants (actual)
- Lead sponsor
- Intergroupe Francophone de Cancerologie ThoraciqueUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Besancon
- Study start
- Jan 2005 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Radiological ArmRadiological arm (Clinical Visit + X-Ray Chest) |
| 2 | Experimental | Procedure: Scannographic armScan ARM : Clinical Visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous type) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- completely resected stage I, II, IIIa, and T4 due to satellite tumor nodule(s) N0-2 NSCLC
Key exclusion criteria (1 listed)
- stage IIIb to IV NSCLC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiological ArmClinical Visit + X-Ray Chest | Procedure or surgery | 1 |
| Scannographic armClinical visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous cell) | Procedure or surgery | 2 |
Primary outcome
Compare overall survival for each arm
Time frame: 6-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Background: PubMed 17519819Westeel 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.
- Derived from this study: PubMed 35964621Westeel 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.
- official IFCT websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie Westeel, Pr principal investigator
Centre Hospitalier Universitaire de Besancon
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiological Arm and Scannographic arm in people with Non-Small-Cell Lung Carcinoma, run by Intergroupe Francophone de Cancerologie Thoracique at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare overall survival for each arm (time frame: 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00198341, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.