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Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer. Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer  Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
For Condition: adenosquamous cell lung cancer,large cell lung cancer,stage 3B non-small cell lung cancer,squamous cell lung cancer
Status: Recruiting
Sponsor(s): Swiss Institute for Applied Cancer Research ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RogerStupp, Study Chair, Centre Hospitalier Universitaire Vaudois
Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne, , CH-1011
Switzerland
Recruiting Roger Stupp 41-21-314-0156
Additional Information:
Study ID Numbers: CDR0000069199; SWS-SAKK-16/01,EU-20137
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030810
Other Squamous Cell Lung Cancer Studies:
1. Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
2. Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer
3. Paclitaxel and Oxaliplatin in Treating Patients With Recurrent or Advanced Non-small Cell Lung Cancer
4. Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
5. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors
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Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
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