Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)
1 other identifier
interventional
120
1 country
1
Brief Summary
Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2 account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or radiotherapy (RT) are insufficient. The neoadjuvant approach was tested, in randomized tests of exclusive CT, or in noncomparative tests of RT-CT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Jan 2003
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedMay 28, 2019
May 1, 2016
5 years
September 13, 2005
May 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities)
at week 22
Study Arms (3)
Cisplatin-Gemzar
EXPERIMENTALCisplatin-Gemzar
Cisplatin-Navelbine-Radiotherapy
EXPERIMENTALCisplatin-Navelbine-Radiotherapy
Carboplatin-Taxol-Radiotherapy
EXPERIMENTALCarboplatin-Taxol-Radiotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Operable and resectable stage IIIA (T1-3, N2) NSCLC
- World Health Organization (WHO) performance status of 1 or less
You may not qualify if:
- Severe cardiac, respiratory, renal or hepatic failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie
Pierre-Bénite, France
Related Publications (1)
Girard N, Mornex F, Douillard JY, Bossard N, Quoix E, Beckendorf V, Grunenwald D, Amour E, Milleron B. Is neoadjuvant chemoradiotherapy a feasible strategy for stage IIIA-N2 non-small cell lung cancer? Mature results of the randomized IFCT-0101 phase II trial. Lung Cancer. 2010 Jul;69(1):86-93. doi: 10.1016/j.lungcan.2009.10.003. Epub 2009 Oct 29.
PMID: 19879013RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francoise Mornex, Pr
Hospices Civils de Lyon
- PRINCIPAL INVESTIGATOR
Bernard Milleron, Dr
Intergroupe Francophone de Cancerologie Thoracique
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
January 1, 2003
Primary Completion
January 1, 2008
Study Completion
July 1, 2012
Last Updated
May 28, 2019
Record last verified: 2016-05