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

Primary Purpose

Non-Small-Cell Lung Carcinoma

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Radiological Arm

Scannographic arm

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Carcinoma focused on measuring Post-surgical Non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier - Pneumologie
CHU Besancon - Pneumologie
Centre F. Baclesse
CHU - Pneumologie
CHU Grenoble - pneumologie
Institut de Cancérologie de la Loire
CHU Lyautey - Pneumologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Radiological arm (Clinical Visit + X-Ray Chest)

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

Outcomes

Primary Outcome Measures

Compare overall survival for each arm

Secondary Outcome Measures

Full Information

NCT ID

NCT00198341

First Posted

September 12, 2005

Last Updated

August 9, 2022

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Collaborators

Centre Hospitalier Universitaire de Besancon

1. Study Identification

Unique Protocol Identification Number

NCT00198341

Brief Title

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

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

January 2005 (Actual)

Primary Completion Date

May 2018 (Actual)

Study Completion Date

July 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Collaborators

Centre Hospitalier Universitaire de Besancon

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small-Cell Lung Carcinoma

Keywords

Post-surgical Non-small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1775 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Radiological arm (Clinical Visit + X-Ray Chest)

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Radiological Arm

Intervention Description

Clinical Visit + X-Ray Chest

Intervention Type

Procedure

Intervention Name(s)

Scannographic arm

Intervention Description

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

Primary Outcome Measure Information:

Title

Compare overall survival for each arm

Time Frame

6-month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Virginie Westeel, Pr

Organizational Affiliation

Centre Hospitalier Universitaire de Besancon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier - Pneumologie

City

Belfort

ZIP/Postal Code

90016

Country

France

Facility Name

CHU Besancon - Pneumologie

City

Besancon

ZIP/Postal Code

25000

Country

France

Facility Name

Centre F. Baclesse

City

Caen

ZIP/Postal Code

14000

Country

France

Facility Name

CHU - Pneumologie

City

Caen

ZIP/Postal Code

14000

Country

France

Facility Name

CHU Grenoble - pneumologie

City

Grenoble

ZIP/Postal Code

38000

Country

France

Facility Name

Institut de Cancérologie de la Loire

City

Saint-priest En Jarez

ZIP/Postal Code

42271

Country

France

Facility Name

CHU Lyautey - Pneumologie

City

Strasbourg

ZIP/Postal Code

63000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

17519819

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.

Results Reference

background

PubMed Identifier

35964621

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.

Results Reference

derived

Links:

URL

http://www.ifct.fr

Description

official IFCT website

Learn more about this trial

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

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