Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC

Official Title
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A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Cisplatin, Ifosfamide, Gemcitabine
* Drug: Ifosfamide, Gemcitabine
* Drug: Cisplatin, docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological diagnosis of non-small cell lung cancer Advanced (unresectable or functionally inoperable) stage III or stage IV disease Availability for participating in the detailed follow-up of the protocol Presence of an evaluable or measurable lesion Informed consent Exclusion Criteria: Prior treatment with chemotherapy Operable patient with resectable tumour Performance status < 60 on the Karnofsky scale A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval) Polynuclear cells < 2,000/mm³ Platelet cells < 100,000/mm³ Serum bilirubin >1.5 mg/100 ml Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min Perception hypoacousia Peripheral neuropathy Recent myocardial infarction (less than 3 months prior to date of diagnosis) Congestive cardiac failure requiring medical therapy or uncontrolled cardiac arrhythmia Uncontrolled infectious disease Serious medical or psychological factors which may prevent adherence to the treatment schedule

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 |
| --- | --- |
| Experimental: A<br> | Drug: Cisplatin, Ifosfamide, Gemcitabine<br>* Cisplatin 50 mg/m² day 1 Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks<br>|
| Active Comparator: B<br> | Drug: Ifosfamide, Gemcitabine<br>* Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks<br>|
| Experimental: C<br> | Drug: Cisplatin, docetaxel<br>* Cisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles every 3 weeks<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 first day of registration until death or last follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | Every 3 courses of chemotherapy | 
| Toxicity |  | After each course of chemotherapy | 
| Activity of second-line chemotherapy |  | Every 3 courses of chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomised phase III, Chemotherapy, Advanced non-small cell lung carcinoma