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

NCT ID: NCT00198367

Last Updated: 2019-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2012-07-31

Brief Summary

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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

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These results justify the choice of the study design currently suggested, testing the preoperative feasibility

1. chemotherapy: cisplatin-Gemzar (arm A) or
2. 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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cisplatin-Gemzar

Cisplatin-Gemzar

Group Type EXPERIMENTAL

Cisplatin-Gemzar

Intervention Type DRUG

Cisplatin-Navelbine-Radiotherapy

Cisplatin-Navelbine-Radiotherapy

Group Type EXPERIMENTAL

Cisplatin-Navelbine-Radiotherapy

Intervention Type DRUG

Carboplatin-Taxol-Radiotherapy

Carboplatin-Taxol-Radiotherapy

Group Type EXPERIMENTAL

Carboplatin-Taxol-Radiotherapy

Intervention Type DRUG

Interventions

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Cisplatin-Gemzar

Intervention Type DRUG

Cisplatin-Navelbine-Radiotherapy

Intervention Type DRUG

Carboplatin-Taxol-Radiotherapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francoise Mornex, Pr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Bernard Milleron, Dr

Role: PRINCIPAL_INVESTIGATOR

Intergroupe Francophone de Cancerologie Thoracique

Locations

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Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie

Pierre-Bénite, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 19879013 (View on PubMed)

Other Identifiers

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IFCT-0101

Identifier Type: -

Identifier Source: org_study_id

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