Randomised Study of Concomitant Radiochemotherapy in Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III Randomised Study Comparing Concomitant Radiochemotherapy With Cisplatin and Docetaxel as Induction Versus Consolidation Treatment in Patients With Locally Advanced Unresectable Non-small Cell Lung Cancer.

Conditions
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Non-small Cell Lung Carcinoma

Intervention / Treatment
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* Drug: Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
* Drug: Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>One course of chemotherapy with cisplatin and docetaxel followed by induction chemoradiotherapy followed by two courses of consolidation chemotherapy | Drug: Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel<br>* 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<br>|
| Experimental: B<br>Three courses of induction chemotherapy followed by consolidation chemoradiotherapy | Drug: Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | Survival will be dated from the day of randomisation until death or last follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cisplatin, Non-small cell lung carcinoma, Concomitant radiochemotherapy, Docetaxel, Radiotherapy, Chemotherapy, Unresectable stage III non-small cell lung carcinoma