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Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Cisplatin-Gemzar
Cisplatin-Navelbine-Radiotherapy
Carboplatin-Taxol-Radiotherapy
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring operable and resectable stage IIIA (T1-3, N2) NSCLC

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Operable and resectable stage IIIA (T1-3, N2) NSCLC World Health Organization (WHO) performance status of 1 or less Exclusion Criteria: Severe cardiac, respiratory, renal or hepatic failure

Sites / Locations

  • Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cisplatin-Gemzar

Cisplatin-Navelbine-Radiotherapy

Carboplatin-Taxol-Radiotherapy

Arm Description

Cisplatin-Gemzar

Cisplatin-Navelbine-Radiotherapy

Carboplatin-Taxol-Radiotherapy

Outcomes

Primary Outcome Measures

percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities)

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
May 23, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT00198367
Brief Title
Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)
Official Title
Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

5. Study Description

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.
Detailed Description
These results justify the choice of the study design currently suggested, testing the preoperative feasibility chemotherapy: cisplatin-Gemzar (arm A) or chemoradiotherapy: cisplatin-navelbine-radiotherapy (arm B) or Carboplatin-Taxol-radiotherapy (arm C). The results obtained, in terms of feasibility and toxicity, will make it possible to select the optimal diagrams for a phase III study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
operable and resectable stage IIIA (T1-3, N2) NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cisplatin-Gemzar
Arm Type
Experimental
Arm Description
Cisplatin-Gemzar
Arm Title
Cisplatin-Navelbine-Radiotherapy
Arm Type
Experimental
Arm Description
Cisplatin-Navelbine-Radiotherapy
Arm Title
Carboplatin-Taxol-Radiotherapy
Arm Type
Experimental
Arm Description
Carboplatin-Taxol-Radiotherapy
Intervention Type
Drug
Intervention Name(s)
Cisplatin-Gemzar
Intervention Type
Drug
Intervention Name(s)
Cisplatin-Navelbine-Radiotherapy
Intervention Type
Drug
Intervention Name(s)
Carboplatin-Taxol-Radiotherapy
Primary Outcome Measure Information:
Title
percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities)
Time Frame
at week 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Operable and resectable stage IIIA (T1-3, N2) NSCLC World Health Organization (WHO) performance status of 1 or less Exclusion Criteria: Severe cardiac, respiratory, renal or hepatic failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francoise Mornex, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernard Milleron, Dr
Organizational Affiliation
Intergroupe Francophone de Cancerologie Thoracique
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie
City
Pierre-Benite
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19879013
Citation
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.
Results Reference
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Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)

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