Non-small Cell Lung Carcinoma
Conditions
Keywords
Non-small cell lung carcinoma, Concomitant radiochemotherapy, Cisplatin, Docetaxel, Radiotherapy, Chemotherapy, Unresectable stage III non-small cell lung carcinoma
Brief summary
The purpose of the present trial is to assess if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison with the same chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy.
Interventions
DRUGConcomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1
DRUGConcomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1
Sponsors
European Lung Cancer Working Party
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Prior treatment with chemotherapy, radiotherapy or surgery * Performance status \< 60 on the Karnofsky scale * History of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval) * Neutrophils \< 2,000/mm³ * Platelet cells \< 100,000/mm3 * Serum bilirubin \> 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 * Known hypersensitivity to docetaxel or cisplatin * Pregnancy or for pre-menopausal patient, incapacity to use adequate contraceptive method
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival | Survival will be dated from the day of randomisation until death or last follow up |
Secondary
| Measure | Time frame |
|---|---|
| Response rate | At the end of the whole treatment |
| Toxicity | After each course of chemotherapy and at the end of treatment |
| Local control rate | After completion of treatment |
Countries
Belgium, France, Greece, Spain
Outcome results
None listed