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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer healthcare trials occur in a lot of of places across 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 effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer  Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,stage 1 non-small cell lung cancer,stage 2 non-small cell lung cancer,stage 3A non-small cell lung cancer
Status: Suspended
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
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 and radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have non-small cell lung cancer that cannot be surgically removed.
Details: OBJECTIVES: - Determine the maximum tolerated dose of radiotherapy in combination with carboplatin and paclitaxel in patients with unresectable non-small cell lung cancer. - Determine the 2-year survival of patients treated with this regimen. - Determine the progression-free local control rate in patients treated this regimen. - Determine the tolerability of this regimen in these patients. - Assess the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of radiotherapy. Patients undergo radiotherapy* once daily 5 days a week. Patients concurrently receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat weekly for 8.5 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level in the phase II portion of the study. NOTE: *No prophylactic nodal radiotherapy is administered. Quality of life is assessed at baseline and then weekly before administration of study drugs. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for the phase I portion of this study within 1-6 months. A maximum of 42 additional patients will be accrued for the phase II portion of this study within 9 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) - Stage I, II, or III NSCLC that is unresectable due to tumor extent or other medical reasons - Measurable disease - Tumor must not exceed volume that would require radiation volumes greater than those allowed on this study - No more than blunting of the costophrenic angle on chest x-ray due to pleural effusions - No more than small effusions seen on chest CT scan only - No supraclavicular adenopathy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR - Direct bilirubin no greater than 1.5 times ULN - AST no greater than 3 times ULN Renal: - Creatinine clearance at least 40 mL/min Cardiovascular: - No New York Heart Association class III or IV heart disease Pulmonary: - FEV_1 at least 1 L or 35% of predicted Other: - No grade 2 or greater peripheral neuropathy - No weight loss of 10% or more within the past 3 months - No uncontrolled infection - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinoma (carcinoma in situ), or localized prostate cancer - No other severe underlying disease that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic: - No concurrent biologic therapy - No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: - No other concurrent chemotherapy Endocrine: - Not specified Radiotherapy: - See Disease Characteristics Surgery: - See Disease Characteristics Other: - No prior treatment for NSCLC
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenSchild, Study Chair, Mayo Clinic Scottsdale
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Altru Cancer Center
Grand Forks, North Dakota, 58201
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Medcenter One Health System
Bismark, North Dakota, 58501-5505
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Additional Information:
Study ID Numbers: CDR0000069250; NCCTG-N0028
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032032
Other Stage 2 Non-Small Cell Lung Cancer Studies:
1. Celecoxib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
2. Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
3. Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
4. Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer
5. Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
Related Studies:
Other stage 2 non-small cell lung cancer Clinical Trials
Other North Dakota Clinical Trials
Other Fargo Clinical Trials
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
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