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Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Non-Small Cell Lung Cancer Clinical research trials and Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Non-Small Cell Lung Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Non-Small Cell Lung Cancer. Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Non-Small Cell Lung Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Non-Small Cell Lung Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Non-Small Cell Lung Cancer  Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Non-Small Cell Lung Cancer
Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Non-Small Cell Lung Cancer
For Condition: adenosquamous cell lung cancer,squamous cell lung cancer,large cell lung cancer,stage 3A non-small 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. It is not yet known if chemotherapy plus radiation therapy is more effective than chemotherapy alone before surgery in treating non-small cell lung cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of chemotherapy with or without radiation therapy followed by surgery in treating patients who have non-small cell lung cancer that has spread to lymph nodes in the chest.
Details: OBJECTIVES: - Compare the feasibility and efficacy of neoadjuvant chemotherapy with or without radiotherapy, in terms of event-free survival, in patients with non-small cell lung cancer with mediastinal lymph node metastases. - Determine the value of positron emission tomography scans for predicting pathological response and event-free survival in patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Compare the objective response rate, failure pattern, and overall survival in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to mediastinal bulk (5 cm or more vs less than 5 cm), weight loss in the past 6 months (5% or more vs less than 5%), and participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Three weeks after the last chemotherapy administration, patients undergo radiotherapy once daily 5 days a week for 3 weeks and boost radiotherapy on days 2, 5, 9, 12, 15, 17, and 19 during the same 3 weeks. - Arm II: Patients receive chemotherapy as in arm I. All patients undergo surgical resection and mediastinal lymph node dissection within 21-28 days after completion of radiotherapy (arm I) or within 21 days after completion of chemotherapy (arm II). Patients are followed at 1 month and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer - Squamous, adenosquamous, large cell, or poorly differentiated - Nodal metastases - T1-3, N2, M0 - N2 disease stage confirmed by mediastinoscopy 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/ALT no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN Renal: - Creatinine clearance greater than 60 mL/min Cardiovascular: - Cardiac function normal - No unstable cardiac disease requiring treatment - No congestive heart failure - No angina pectoris even if medically controlled - No significant arrhythmia - No myocardial infarction in the past 3 months Pulmonary: - Lung function appropriate Neurologic: - No history of significant neurologic or psychiatric disorders - No psychotic disorders - No dementia - No seizures Other: - No other prior or concurrent malignancies except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix - No active uncontrolled infection - No uncontrolled diabetes mellitus - No gastric ulcers - No pre-existing peripheral neuropathy greater than grade 1 - No contraindications to corticosteroids - No other serious underlying medical condition that would preclude study participation - No socioeconomic or geographic condition that would preclude study participation - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior cytostatic chemotherapy Endocrine therapy: - No concurrent prednisone except for treatment of acute hypersensitivity reactions or chronic low-dose treatment initiated more than 6 months prior to study entry (i.e., no greater than 20 mg methylprednisolone or equivalent) Radiotherapy: - No prior radiotherapy to chest Surgery: - Not specified Other: - At least 30 days since participation in another clinical study - No other concurrent experimental drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MiklosPless, Study Chair, Universitatsklinken Basel
Universitatsklinken Basel *Recruiting*
Basel, , CH-4031
Switzerland
Recruiting Miklos Pless 4161 265 53 07
Additional Information:
Study ID Numbers: CDR0000069196; EU-20138,SWS-SAKK-16/00
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030771
Other Large Cell Lung Cancer Studies:
1. Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
2. Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer
3. Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
4. Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer
5. Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
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Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Non-Small Cell Lung Cancer
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