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Completed

NCT Number: NCT00198367

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie

Pierre-Bénite, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin-Gemzar

Drug

Cisplatin-Navelbine-Radiotherapy

Drug

Carboplatin-Taxol-Radiotherapy

Drug

Primary outcomes

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

    Time frame: at week 22

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study

Important dates

Study start
2003
Primary completion
2008
Study completion
2012
First posted
Sep 20, 2005
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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