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Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer Clinical research trials and Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer. Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer  Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
For Condition: stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer,Quality of Life,childhood thorax/respiratory cancer
Status: No longer recruiting
Sponsor(s): Istituto Nazionale per lo Studio e la Cura dei Tumori , National Cancer Institute of Canada
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Details: OBJECTIVES: I. Compare gemcitabine plus vinorelbine vs standard chemotherapy containing cisplatin in terms of the effect on the quality of life of patients with stage IIIB or IV non-small cell lung cancer. II. Compare the effect of these regimens on the overall survival of these patients. III. Compare the toxic effects of these regimens in these patients. IV. Compare the effect of these regimens on the rate of objective response in these patients. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, stage of disease (IIIB vs IV), and performance status (0 vs 1 vs 2). Patients are randomized to one of two treatment arms. Arm I: Patients receive cisplatin IV on day 1 and either gemcitabine IV or vinorelbine IV on days 1 and 8. Arm II: Patients receive gemcitabine IV and vinorelbine IV on days 1 and 8. Treatment repeats every 21 days for up to 6 courses. Quality of life is assessed prior to therapy and before each course of chemotherapy to the fourth course. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /69 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically proven non-small cell lung cancer; Stage IV OR Stage IIIB with supraclavicular lymph node metastases and/or pleural effusion that is not curable with radiotherapy - Measurable or evaluable disease - No CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; Concurrent palliative radiotherapy allowed - Surgery: Not specified --Patient Characteristics-- - Age: Under 70 - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Neutrophil count at least 2000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: (Unless caused by liver metastases); Bilirubin no greater than 1.25 times upper limit of normal (ULN); SGOT or SGPT no greater than 1.25 times ULN - Renal: Creatinine no greater than 1.25 times ULN - Other: No prior or concurrent malignancy except basal or squamous cell skin cancer or carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CesareGridelli, Study Chair, Istituto Nazionale per lo Studio e la Cura dei Tumori
Azienda Ospedaliena G. Rummo
Benevento, , 82100
Italy
Ospedali Riuniti
Reggio Calabria, , 89100
Italy
Ospedale Oncologieo G. Fortunato
Rionero, ,
Italy
Federico II University Medical School
Naples, , 80131
Italy
Ospedale Vincenzo Monaldi
Napoli, , 80131
Italy
Ospedale Civile Avellino
Avellino, ,
Italy
Ospedale Maggiore Lodi
Lodi, , I-20075
Italy
Ospedale G. Di Maria - Avola (SR)
Avola (SR), ,
Italy
Ospedale San Carlo
Potenza, , 85100
Italy
U.S.S.L. 33
Rho, ,
Italy
Ospedale La Maddalena - Palermo
Palermo, ,
Italy
Ospedale Cardarelli - Campobasso
Campobasso, ,
Italy
Ospedale Civile - Rovereto
Rovereto, ,
Italy
Ospedale di Legnano
Legnano, , 20025
Italy
Ospedale S. Gennora USL 42
Naples, , 80136
Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , 80131
Italy
Ospedale San Carlo Borromeo
Milan, , 20153
Italy
Istituti Fisioterapici Ospitalieri - Roma
Rome, , 00161
Italy
Ospedale San Bortolo
Vicenza, , 36100
Italy
Ospedale Agnelli
Pinerolo, , 10064
Italy
Istituto Di Science Biomediche San Paolo
Milano, , 20142
Italy
Universita di Palermo
Palermo, , 90141
Italy
Ospedale San Martino/Cliniche Universitarie Convenzionate
Genoa, , 16132
Italy
Ospedale S. Francesco - Paola
Paola (CS), ,
Italy
Ospedale Gen. Provinciale Santa Maria Goretti
Latina, , 04100
Italy
ASL 2 - Napoli
Napoli, ,
Italy
Ospedale Di Gabargnate Milanese
Milan, , 20024
Italy
Ospedale San Lazzaro
Alba, , 12051
Italy
Ospedale Civile Cosenza
Cosenza, , 87100
Italy
Additional Information:
Study ID Numbers: CDR0000067316; ITA-GEMVIN,EU-99016
Study Start Date: November 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004100
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma
2. Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
3. Diagnosis and Treatment Planning in Patients Suspected of Having Lung Cancer
4. Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other Clinical Trials
Other Reggio Calabria Clinical Trials
Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
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