Unresectable non metastatic stage III non small cell lung carcinoma eligible for concomitant radiochemotherapy MedDRA version: 9.1 Level: HLGT Classification code 10038666 Term: Respiratory and mediastinal neoplasms malignant and unspecified
Conditions
Interventions
Trade Name: Docetaxel
Product Name: taxotere
Pharmaceutical Form: Intravenous infusion
CAS Number: 114977-28-5
Other descriptive name: DOCETAXEL
Concentration unit: mg/m2 milligram(s)/square meter
Con
Sponsors
CHRU de Lille
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men or women aged = 18 years old - Histological or cytological diagnosis of non-small cell carcinoma of the lung - Initially unresectable non-metastatic stage III disease - Availability for participating in the detailed follow-up of the protocol - Presence of an evaluable or measurable lesion - Written informed consent - No functional or anatomical contraindication to chest irradiation - Irradiation technically possible Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Prior treatment with chemotherapy, radiotherapy or surgery - Performance status 1.5 mg/100 ml - Hepatic disease contra-indicating the administration of docetaxel and/or GOT or GPT = 2.5x the normal value and/or alkaline phosphatase = 5x the normal value - Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min - Recent myocardial infarction (less than 3 months prior to date of diagnosis) or uncontrolled angina pectoris - Congestive cardiac failure or cardiac arrhythmia requiring medical treatment - Uncontrolled infectious disease - Symptomatic polyneuropathy - Auditive impairment contra-indicating cisplatin administration - Serious medical or psychological factors which may prevent adherence to the treatment schedule - Malignant pleural or pericardial effusion - Homolateral supraclavicular lymph node excepting upper lobe lesion - Heterolateral supraclavicular lymph node - Allergy or known hypersensitivity to docetaxel or cisplatin - Women of child bearing potential not consenting to use adequate contraceptive precautions - Female subject who is pregnant or breastfeeding - Aberrations from the radiotherapy guidelines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison to induction chemotherapy followed by consolidation concurrent chemoradiotherapy in patients with unresectable locally advanced non-small cell lung cancer;Secondary Objective: - to determine the objective response rate between the two therapeutic approaches - to determine the toxicity between the two therapeutic approaches - to determine the local control rate obtained in each arm ;Primary end point(s): The primary endpoint of the study will be to compare the distributions of the survival duration between the two arms. | — |
Countries
France
Outcome results
None listed