Overview

This trial is active, not recruiting.

Condition non-small-cell lung carcinoma
Treatments radiological arm, scannographic arm
Phase phase 3
Sponsor Intergroupe Francophone de Cancerologie Thoracique
Collaborator Centre Hospitalier Universitaire de Besancon
Start date January 2005
End date December 2017
Trial size 1744 participants
Trial identifier NCT00198341, IFCT-0302

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Radiological arm (Clinical Visit + X-Ray Chest)
radiological arm
Clinical Visit + X-Ray Chest
(Experimental)
Scan ARM : Clinical Visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous type)
scannographic arm
Clinical visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous cell)

Primary Outcomes

Measure
Compare overall survival for each arm
time frame: 6-month

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Multicentric Randomized Phase III Study of Post-Surgical NSCLC Follow-up
Principal investigator Virginie Westeel, Pr
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Intergroupe Francophone de Cancerologie Thoracique.