Concurrent Chemoradiotherapy Using Intensity Modulated Radiotherapy (IMRT) & Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

• Response rate (by contrast CT scan)

Secondary Objectives:

• Progression-free survival (PFS)

• Overall survival (OS)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Carboplatin; Cisplatin; Docetaxel

Criteria

Inclusion criteria:

• Pathologically proven locally advanced, inoperable, confirmed by PET scan (thorax/ upper abdomen) to be International stage III (2009) NSCLC and without multifocal tumours in the lung

• Disease volume encompassible within a tolerable Planning Target Volume treated to 66 Gy

• FEV1 (Force Expiratory Volume in 1 Second) >1000 ml

• Hemoglobin ≥ 9.0 g/dl

• Absolute neutrophil count (ANC) ≥ 1,500/mm3

• Platelet count ≥ 100,000/mm3

• Total bilirubin ≥ 1.5 times the upper limit of normal

• ALT (Alanine Aminotransferase) and AST (Aspartate transaminase) ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for patients with liver derangement)

• ECOG (Eastern Cooperative Oncology Group) PS 0-1

Exclusion criteria:

• Previous treatment with chest radiotherapy, chemotherapy or molecularly targeted agents

• Inadequate lung function (Exercise tolerance less than 1 FOS/Fight of stairs, FEV1 < 1 L/sec, or raised pCO2)

• History of hypersensitivity or contraindication to the study drugs or pre-medications or products formulated in polysorbate 80

• Pregnant or breast-feeding women, or women with child-bearing potential who are not following an effective method of contraception and/or who are unwilling or unable to be tested for pregnancy (either by serum or urine pregnancy test before study entry

• Participation in a clinical trial with any investigational drug used and within 30 days prior to study entry

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.