Lung Cancer
Conditions
Keywords
squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer, adenosquamous cell lung cancer
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 before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.
Detailed description
OBJECTIVES: * Determine the feasibility and efficacy of sequential neoadjuvant docetaxel, cisplatin, and radiotherapy followed by surgery in patients with operable stage IIIB non-small cell lung cancer. * Determine the rate of event-free survival at 1 year in patients treated with this regimen. * Determine the operability and complete resection rate in patients treated with this regimen. * Determine the postoperative 30-day mortality in patients treated with this regimen. * Determine the response rate, failure pattern, and overall survival in patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity. Beginning 3 weeks after the last chemotherapy dose, patients without progressive disease receive radiotherapy 1-2 times daily on days 1-5, 8-12, and 15-19. Patients undergo surgery within 3-4 weeks after completion of radiotherapy. Patients are followed at 1 month and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-46 patients will be accrued for this study.
Interventions
RADIATIONHyperfractionated
Hyperfractionated radiotherapy
DRUGTaxotere/Cisplatin
Taxotere/Cisplatin
PROCEDUREconventional surgery
conventional surgery
Sponsors
Swiss Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed, operable stage IIIB non-small cell lung cancer * T4 N0-3 M0 or T1-4 N3 M0 by bronchoscopy and mediastinoscopy (required for assessment of N3 disease) or CT scan or MRI of the thorax * Squamous cell * Adenosquamous cell * Large cell * Poorly differentiated * No prior or concurrent metastatic disease by CT scan or MRI of the brain, bone scan, and abdominal ultrasound or CT scan * No malignant pleural or pericardial effusion * No invasion of the aorta, esophagus, myocardium, or supraclavicular nodes PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 4,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * AST and/or ALT no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine clearance at least 60 mL/min Cardiovascular: * No unstable cardiac disease requiring treatment * No congestive heart failure * No angina pectoris (even if medically controlled) * No significant arrhythmia * No myocardial infarction within the past 3 months Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No definite contraindications for the use of corticosteroids as premedication * No preexisting grade 2 or greater peripheral neuropathy * No active uncontrolled infection * No uncontrolled diabetes mellitus * No other prior or concurrent malignancy except non-melanomatous skin cancer or adequately treated carcinoma in situ of the cervix * No prior significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude informed consent * No other serious underlying medical condition that would preclude study participation * No socioeconomic or geographical circumstances that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No concurrent corticosteroids except as prophylactic pretreatment medication, treatment for acute hypersensitivity reactions, or chronic treatment (initiated more than 6 months ago) at low-dose (no more than 20 mg methylprednisolone or equivalent) Radiotherapy: * No prior radiotherapy to the chest Surgery: * See Disease Characteristics Other: * At least 30 days since prior treatment in a clinical trial * No prior cytostatic therapy * No other concurrent experimental drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of event-free survival measured 1 year after registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Operability after chemotherapy | — |
| Postoperative mortality 30 days after surgery | — |
| Complete resection rate after surgery | — |
| Toxicity | — |
| Response rate | — |
Countries
Switzerland
Outcome results
None listed