Combination Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
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 combining chemotherapy and radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.

Detailed Description
-----------------
OBJECTIVES: Determine the incidence of radically resected disease in patients with stage IIIB non-small cell lung cancer treated with induction cisplatin, etoposide, and radiotherapy followed by surgical resection. Determine the toxicity (morbidity and mortality) of this regimen in these patients. Determine the clinical response rate and pathological response rate in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive induction chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3. Chemotherapy repeats every 3 weeks for 3 courses. Beginning on day 2 of the second course of chemotherapy, patients undergo induction radiotherapy once daily 5 days a week for 5-7 weeks. Chemoradiotherapy continues in the absence of disease progression or unacceptable toxicity. At 3-6 weeks after completion of the last dose of induction radiotherapy, patients undergo lobectomy or pneumonectomy. Patients are followed at 30 days and 4 months, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 27-62 patients will be accrued for this study.

Official Title
-----------------
Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: cisplatin
* Drug: etoposide
* Procedure: conventional surgery
* Radiation: radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed primary stage IIIB non-small cell lung cancer (NSCLC) T4, any N, M0 or any T, N3, M0 No N3 disease due to scalene or supraclavicular lymph node involvement No primary tumors located in the lower lobe combined with contralateral upper higher mediastinal lymph node involvement No mixed tumor types with small cell lung cancer At least 1 unidimensionally measurable target lesion At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan No pre-existing pleural or pericardial effusion No CNS involvement by CT scan or MRI PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm^3 Platelet count at least 100,000/mm ^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 1.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.25 times ULN Creatinine clearance at least 60 mL/min Cardiovascular: No clinical evidence of superior vena cava syndrome Pulmonary: Postoperative FEV1 and KCO greater than 40% predicted VO2 max greater than 15 mL/min/kg (if postoperative KCO no greater than 40% predicted) Other: No other primary malignancy except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or other malignancy treated more than 5 years ago without recurrence (excluding melanoma, breast cancer, or hypernephroma) No active uncontrolled infection requiring IV antibiotics No pre-existing sensory neurotoxicity grade 2 or greater No psychological, familial, sociological, or geographical condition that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for NSCLC No concurrent immunotherapy during induction chemoradiotherapy Concurrent colony stimulating factors allowed Chemotherapy: No prior chemotherapy for NSCLC Endocrine therapy: No concurrent anticancer hormonal agents (except corticosteroids for antiemetic prophylaxis) during induction chemoradiotherapy Radiotherapy: No prior radiotherapy for NSCLC Surgery: No prior surgery for NSCLC Other: No other concurrent anticancer drugs during induction chemoradiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: etoposide|nan|
|Procedure: conventional surgery|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

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

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