Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as paclitaxel may make tumor cells more sensitive to radiation therapy. It is not yet known if combination chemotherapy followed by radiation therapy is more effective with or without paclitaxel in treating unresectable stage III non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by radiation therapy with or without paclitaxel in treating patients who have unresectable stage III non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Compare the overall survival rate of patients with unresectable stage III non-small cell lung cancer treated with paclitaxel and carboplatin or cisplatin followed by radiotherapy with or without concurrent paclitaxel. Compare the 1-year survival rate and mean survival time in patients treated with these regimens. Compare the objective response rate and local control in patients treated with these regimens. Compare the tolerability of these regimens in these patients. Compare the safety profile and toxicity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes or cisplatin IV on day 1. Treatment repeats every 21 days for 2 courses. Patients then proceed to randomized treatment. Arm I: Patients receive paclitaxel IV over 1 hour on day 1 and radiotherapy on days 1-5 of each week for 6 weeks. Arm II: Patients receive radiotherapy 5 days a week for 7 weeks. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.

Official Title
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Phase III Randomized Study of Paclitaxel and Carboplatin or Cisplatin Followed by Radiotherapy With or Without Concurrent Paclitaxel in Patients With Unresectable Stage III Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: chemotherapy
* Drug: cisplatin
* Drug: paclitaxel
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC) Locoregionally advanced unresectable disease Previously untreated Measurable disease No involvement of supraclavicular lymph nodes No cytologically positive pleural or pericardial effusion No invasion to the wall of the esophagus or the cardiac ventricle No bone marrow involvement No distant metastases PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-1 Life expectancy: At least 12 weeks Hematopoietic: WBC greater than 4,000/mm^3 Absolute neutrophil count greater than 2,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin less than upper limit of normal (ULN) AST and ALT less than 2.5 times ULN Alkaline phosphatase less than 5 times ULN No hepatic abnormalities Renal: Creatinine less than ULN Cardiovascular: No myocardial infarction within the past 6 months No cardiac insufficiency No uncontrolled arrhythmia Pulmonary: FEV1 greater than 1 L DLCO at least 30% predicted No pneumonia No other non-disease-related pulmonary complications Other: No more than 10% of total weight loss over the past 6 months No other disease that would preclude study No peripheral neuropathy grade 3 or greater No other prior or concurrent malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No familial, geographic, or psychological condition that would preclude study Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy No concurrent immunotherapy Chemotherapy: No prior systemic chemotherapy Endocrine therapy: No concurrent endocrine therapy Radiotherapy: No prior radiotherapy for NSCLC Surgery: See Disease Characteristics No prior complete resection of tumor Prior radical surgical resection allowed if local recurrence of disease No concurrent major surgery Other: No other concurrent anticancer therapy or investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: chemotherapy|nan|
|Drug: cisplatin|nan|
|Drug: paclitaxel|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-year survival rate and mean survival time |  |  | 
| Objective response rate and local control |  |  | 
| Tolerability |  |  | 
| Safety profile, in terms of acute and delayed toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer