Elderly NSCLC/D vs DP (JCOG0207)

Study Overview
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Brief Summary
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To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.

Detailed Description
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The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). In a large randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. With the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. There have been no randomized prospective trials dedicated to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based combination. Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.

Official Title
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Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)

Conditions
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Non-small-cell Lung Cancer

Intervention / Treatment
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* Drug: Weekly docetaxel alone
* Drug: Weekly docetaxel + cisplatin combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically or cytologically proven non-small-cell lung cancer stage IV, or stage III disease ineligible for definitive radiotherapy 70 years or older ECOG PS 0-1 Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms No prior surgery within 4 weeks before enrollment No prior radiotherapy for primary tumor No prior radiotherapy for metastatic lesions within 2 weeks before enrollment Adequate organ function Signed informed consent Exclusion Criteria: Symptomatic brain metastasis Active another neoplasms Severe SVC syndrome Massive pericardial, pleural effusion, or ascites Bone metastasis emergent for palliative radiotherapy or surgery Uncontrollable systemic hypertension Heart failure, Unstable angina, Myocardial infarction within 6 months Uncontrollable diabetes Active infection Interstitial pneumonia/ Pulmonary fibrosis Hypersensitivity for polysorbate 80 Systemic administration of corticosteroids

Ages Eligible for Study
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Minimum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: Weekly docetaxel alone|nan|
|Drug: Weekly docetaxel + cisplatin combination|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Progression-free survival |  |  | 
| Response rate |  |  | 
| Symptom score |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, advanced, non-small-cell lung cancer, cisplatin, docetaxel, weekly, combination, chemotherapy, randomized trial