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Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery Clinical research trials and Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery healthcare trials happen in a lot of of localities across the United States of America. 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 / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery. Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery clinical trial. Human subjects often receive the most effective healthcare possible for their Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery  Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
For Condition: squamous cell lung cancer,large cell lung cancer,stage 3 non-small cell lung cancer,adenocarcinoma of the lung
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
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. It is not yet known whether giving chemotherapy before combined chemotherapy and radiation therapy is more effective than combined chemotherapy and radiation therapy alone in treating patients with non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin and paclitaxel followed by radiation therapy and chemotherapy with radiation therapy and chemotherapy alone in treating patients with stage III non-small cell lung cancer that cannot be removed during surgery.
Details: OBJECTIVES: I. Compare the effects of concurrent chemoradiotherapy utilizing carboplatin and paclitaxel with or without prior induction chemotherapy on overall response rate, disease-free survival, and overall survival in patients with unresectable stage III non-small cell lung cancer. II. Compare the effects of these treatments on locoregional vs distant failure in these patients. III. Compare the toxicity of these treatments in these patients. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by measurable vs evaluable disease. Patients are randomized to 1 of 2 treatment arms: Arm I (immediate concurrent chemoradiotherapy): Patients receive IV paclitaxel over 1 hour followed by IV carboplatin over 30 minutes on day 1, and radiation therapy to the chest 5 times a week beginning on day 1. Treatment repeats weekly for a total of 7 courses. Arm II (induction chemotherapy followed by delayed concurrent chemoradiotherapy): Patients receive IV paclitaxel over 3 hours followed by IV carboplatin over 30 minutes; treatment repeats every 3 weeks for 2 courses. Patients then receive 7 courses of concurrent chemoradiotherapy as in Arm I. Total treatment time is 13 weeks. Patients are followed every 2 months for 2 years, then every 4 months for the next 2 years, then annually thereafter. PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed non-small cell lung cancer, including: Squamous cell carcinoma; Adenocarcinoma (including bronchoalveolar cell); Large cell anaplastic carcinoma (including giant and clear cell carcinomas) - Inoperable or unresectable stage IIIA or IIIB disease of the following stage groupings: T1 N2 M0 or T2 N2 M0 T3 N2 M0 and T4 N0-2 M0 eligible if staging is based on closeness to the carina or invasion of the mediastinum or chest wall - Patients with contralateral mediastinal disease (N3) or tumors adjacent to but not invading a vertebral body are eligible if all gross disease can be encompassed in the study radiation boost field - Patients with a transudate, cytologically negative, nonbloody pleural effusion are eligible if the tumor can be encompassed within a reasonable field of radiotherapy - Measurable or evaluable disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormones except for steroids administered for adrenal failure or septic shock, or hormones administered for non-disease-related conditions (e.g., insulin for diabetes); Glucocorticosteroids permitted as antiemetics - Radiotherapy: No prior radiotherapy - Surgery: At least 2 weeks since exploratory thoracotomy --Patient Characteristics-- - Age: 18 and over - Performance status: CALBG 0-1 - Life expectancy: Not specified - Hematopoietic: Platelet count at least 100,000/mm3; Absolute granulocyte count at least 1,500/mm3 - Hepatic: Bilirubin less than 1.5 mg/dL; AST less than 2 times upper limit of normal - Renal: Creatinine clearance at least 20 mL/min - Other: Not pregnant or nursing; Effective contraception required of fertile patients; No active second malignancy except nonmelanomatous skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EverettVokes, Study Chair, Cancer and Leukemia Group B
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Cooper Cancer Institute
Camden, New Jersey, 08103
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Additional Information:
Study ID Numbers: CDR0000066383; CLB-39801,CTSU
Study Start Date: July 1998
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003387
Other Stage 3 Non-Small Cell Lung Cancer Studies:
1. Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer
2. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
3. Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
4. Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
5. Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
Related Studies:
Other stage 3 non-small cell lung cancer Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
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