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

Phase 2

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Cisplatin-Gemzar; Drug: Cisplatin-Navelbine-Radiotherapy; Drug: Carboplatin-Taxol-Radiotherapy

• Registration Number: NCT00198367
• Lead Sponsor: Hospices Civils de Lyon

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

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.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2008-01
• Study Completion: 2012-07
• Status Verified: 2016-05
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cisplatin-Gemzar	Cisplatin-Gemzar	Cisplatin-Gemzar
Cisplatin-Navelbine-Radiotherapy	Cisplatin-Navelbine-Radiotherapy	Cisplatin-Navelbine-Radiotherapy
Carboplatin-Taxol-Radiotherapy	Carboplatin-Taxol-Radiotherapy	Carboplatin-Taxol-Radiotherapy

Primary Outcome Measures

Name	Time	Method
percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities)	at week 22

Trial Locations

Locations (1)

Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie; 🇫🇷 Pierre-Benite, France