S0022:Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB 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. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage IIIB non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Determine survival and time to treatment failure in patients with stage IIIB non-small cell lung cancer treated with induction docetaxel, cisplatin, and radiotherapy followed by consolidation docetaxel. Determine the response rate in these patients when treated with this regimen. Determine the toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive induction chemotherapy comprising docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 60 minutes on days 1, 8, 29, and 36. Patients also undergo concurrent radiotherapy daily, 5 days per week, for 6.5 weeks. At least 1 week and no more than 4 weeks after completion of induction chemoradiotherapy, patients with stable or responding disease receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.

Official Title
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Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: docetaxel
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB non-small cell lung cancer Adenocarcinoma Large cell carcinoma Squamous cell carcinoma Pathologically or radiographically documented positive N3 nodes No positive supraclavicular or scalene lymph nodes with disease extending into the cervical region OR T4 tumor invading any of the following: Mediastinum Heart Great vessels Trachea Esophagus Vertebral body Carina No brain, contralateral chest, liver, or adrenal metastases No more than 1 parenchymal lesion No malignant pleural effusions unless they are only visible on CT scan or deemed too small to tap No pericardial effusions Measurable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Not specified Renal: Creatinine clearance at least 50 mL/min Pulmonary: One of the following: FEV1 at least 2.0 L Predicted FEV1 of contralateral lung greater than 800 mL Predicted post-treatment FEV1 at least 1.0 L Other: No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent growth factors during induction chemoradiotherapy Chemotherapy: No prior chemotherapy for lung cancer Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for lung cancer Surgery: No prior surgical resection of lung cancer Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery for determining diagnosis, stage, or potential resectability allowed

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chemo/RT followed by consolidation chemo<br>cisplatin docetaxel radiation therapy | Drug: cisplatin<br> <br> Drug: docetaxel<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung