Clinical trial NCT00198341: Post-Surgical Non-Small Cell Lung Cancer (NSCLC) Follow-up
Official title: Multicentric Randomized Phase III Study of Post-Surgical NSCLC Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: Post-surgical Non-small cell lung cancer
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Besancon
First posted: 2005-09-20
Enrollment: 1775
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Compare overall survival for each arm
timeFrame: 6-month
Secondary outcomes:
Other outcomes:
Locations:
city: Belfort
country: France
facility: Centre Hospitalier - Pneumologie
city: Besancon
country: France
facility: CHU Besancon - Pneumologie
city: Caen
country: France
facility: Centre F. Baclesse
city: Caen
country: France
facility: CHU - Pneumologie
city: Grenoble
country: France
facility: CHU Grenoble - pneumologie
city: Saint-priest En Jarez
country: France
facility: Institut de Cancérologie de la Loire
city: Strasbourg
country: France
facility: CHU Lyautey - Pneumologie
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Virginie Westeel, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.