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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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Civil Hospices of Lyon

Status and phase

Completed
Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Carboplatin-Taxol-Radiotherapy
Drug: Cisplatin-Navelbine-Radiotherapy
Drug: Cisplatin-Gemzar

Study type

Interventional

Funder types

Other

Identifiers

NCT00198367
IFCT-0101

Details and patient eligibility

About

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.

Full description

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.

Enrollment

120 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 3 patient groups

Cisplatin-Gemzar
Experimental group
Description:
Cisplatin-Gemzar
Treatment:
Drug: Cisplatin-Gemzar
Cisplatin-Navelbine-Radiotherapy
Experimental group
Description:
Cisplatin-Navelbine-Radiotherapy
Treatment:
Drug: Cisplatin-Navelbine-Radiotherapy
Carboplatin-Taxol-Radiotherapy
Experimental group
Description:
Carboplatin-Taxol-Radiotherapy
Treatment:
Drug: Carboplatin-Taxol-Radiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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