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Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer healthcare trials happen in many 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 drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer. Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer  Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
For Condition: squamous cell lung cancer,stage 3A non-small cell lung cancer,bronchoalveolar cell lung cancer,large cell lung cancer,adenocarcinoma of the lung,stage 3B non-small cell lung cancer
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , 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. Computer systems that allow doctors to create a 3-dimensional picture of the tumor to plan treatment may result in more effective radiation therapy. It is not yet known which chemotherapy and/or radiation therapy regimen is more effective in treating non-small cell lung cancer. PURPOSE: Randomizedphase II trial to compare the effectiveness of different combination chemotherapy regimens and 3-dimensional radiation therapy in treating patients who have unresectablestage III non-small cell lung cancer.
Details: OBJECTIVES: - Compare the overall response rate, failure-free survival, and survival of patients with inoperable stage IIIA or IIIB non-small cell lung cancer treated with paclitaxel and carboplatin with concurrent 3-dimensional conformal radiotherapy (3-D XRT) vs gemcitabine and carboplatin with concurrent 3-D XRT. - Compare the toxicity of these regimens in these patients. - Compare the pattern of failure (locoregional vs distant failure) in patients treated with these regimens. - Determine the feasibility of delivering 3-D XRT to patients in this multicenter study. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. - Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes once weekly and 3-dimensional conformal radiotherapy (3-D XRT) once daily 5 days a week. Treatment repeats weekly for 7 courses. - Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive gemcitabine IV over 30 minutes twice weekly and 3-D XRT as in arm I. Treatment repeats weekly for 7 courses. In both arms, treatment continues in the absence of disease progression. Patients are followed every 2 months for 2 years, every 4 months for 2 years, and then annually for 2 years. PROJECTED ACCRUAL: A total of 82 patients (41 per treatment arm) will be accrued for 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) - Squamous cell carcinoma - Adenocarcinoma, including bronchoalveolar cell carcinoma - Large cell anaplastic carcinoma, including giant and clear cell carcinoma - Inoperable stage IIIA or IIIB disease - No direct invasion of vertebral body - Tumors adjacent to a vertebral body without bone invasion allowed if all gross disease can be encompassed in radiotherapy boost field - Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in radiotherapy boost field - No scalene, supraclavicular, or contralateral hilar node involvement - Transudate, cytologically negative, non-bloody pleural effusion allowed if it can be encompassed in radiotherapy field - No exudative, bloody, or cytologically malignant pleural effusion - Evidence of pleural effusion by chest CT scan but not chest x-ray that is too small to tap allowed - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - The following are not considered measurable disease: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Tumor lesions in a previously irradiated field PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin less than 1.5 mg/dL - AST less than 2 times upper limit of normal Renal: - Creatinine clearance 20-130 mL/min for females - Creatinine clearance 20-150 mL/min for males Pulmonary: - FEV1 at least 1.2 L Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No other currently active malignancy (defined as completed prior therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for NSCLC - No other concurrent chemotherapy Endocrine therapy: - No concurrent hormonal therapy except steroids for adrenal failure or septic shock, hormones for non-disease-related conditions (e.g., insulin for diabetes), or glucocorticosteroids as antiemetics Radiotherapy: - See Disease Characteristics - No prior radiotherapy for NSCLC Surgery: - At least 2 weeks since prior exploratory thoracotomy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ArthurBlackstock, Study Chair, Comprehensive Cancer Center of Wake Forest University
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-982-4963
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Bruce Peterson 612-624-5631
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting Richard Shadduck 412-578-4355
Veterans Affairs Medical Center - Columbia (Truman Memorial) *Recruiting*
Columbia, Missouri, 65201
United States
Recruiting William Patterson 573-882-6163
Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Edward Gelmann 202-444-7303
Louis A. Weiss Memorial Hospital *Recruiting*
Chicago, Illinois, 60640
United States
Recruiting Keith Shulman 773-564-5022
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1009
United States
Recruiting Gerald Clamon 319-356-1932
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7295
United States
Recruiting Mark Socinski 919-966-3036
St. Mary's Medical Center *Recruiting*
Huntington, West Virginia, 25701
United States
Recruiting Gerrit Kimmey 304-528-4645
University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester, Massachusetts, 01655
United States
Recruiting Pankaj Bhargava 508-856-6884
Northeast Alabama Regional Medical Center *Recruiting*
Anniston, Alabama, 36207
United States
Recruiting Thomas Twele 256-236-2549
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Lewis Silverman 212-241-5520
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Martin Edelman 410-328-2703
Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Barry Levinson 214-648-4193
New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett, New Hampshire, 03106
United States
Recruiting Douglas Weckstein 603-622-6484
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Clifford Hudis 212-639-6483
Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica, New York, 11432
United States
Recruiting Hans Grunwald 718-883-4118
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst, North Carolina, 28374
United States
Recruiting Ellen Willard 910-295-9205
University of Puerto Rico School of Medicine Medical Sciences Campus *Recruiting*
San Juan, , 00936-5067
Puerto Rico
Recruiting Enrique Velez-Garcia 787-754-0101 Ext.2020
Veterans Affairs Medical Center - White River Junction *Recruiting*
White River Junction, Vermont, 05009
United States
Recruiting Joseph O'Donnell 802-295-9363 ext. 5480
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103
United States
Recruiting Edison Catalano 856-342-2506
Walter Reed Army Medical Center *Recruiting*
Washington D.C., District of Columbia, 20307-5000
United States
Recruiting Joseph Drabick 202-782-6751
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Cape Fear Valley Health System *Recruiting*
Fayetteville, North Carolina, 28302-2000
United States
Recruiting Kamal Bakri 910-609-6910
Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Paul Conkling 757-466-8683
Broward General Medical Center *Recruiting*
Ft. Lauderdale, Florida, 33316
United States
Recruiting Luis Barreras 954-771-0692
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Margaret Kessinger 402-559-7511
Palm Beach Cancer Institute *Recruiting*
West Palm Beach, Florida, 33401
United States
Recruiting Robert Jacobson 561-366-4150
Elmhurst Hospital Center *Recruiting*
Elmhurst, New York, 11373
United States
Recruiting Vladimir Benisovich 718-334-3723
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting George Canellos 617-632-3470
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Stephen Graziano 315-464-8200
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Jeffrey Crawford 919-684-5195
Lenoir Memorial Hospital Cancer Center *Recruiting*
Kinston, North Carolina, 28503-1678
United States
Recruiting Peter Watson 919-559-2200 Ext. 201
Veterans Affairs Medical Center - Syracuse *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Stephen Graziano 315-476-7461
Veterans Affairs Medical Center - Buffalo *Recruiting*
Buffalo, New York, 14215
United States
Recruiting Lynn Steinbrenner 716-862-3191
Florida Hospital Cancer Institute *Recruiting*
Orlando, Florida, 32804
United States
Recruiting Jane Crofton 407-303-2090
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting Sreenivasa Nattam 219-484-8830
Missouri Baptist Cancer Center *Recruiting*
St. Louis, Missouri, 63131
United States
Recruiting Alan Lyss 314-996-5514
Lifespan: The Miriam Hospital *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting William Sikov 401-793-7151
Baptist Hospital East - Louisville *Recruiting*
Louisville, Kentucky, 40207
United States
Recruiting Daniel Scullin 502-897-1166
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92093-0658
United States
Recruiting Stephen Seagren 858-657-7020
Veterans Affairs Medical Center - Durham *Recruiting*
Durham, North Carolina, 27705
United States
Recruiting Michael Kelley 919-286-0411
Saint Anthony Medical Center *Recruiting*
Rockford, Illinois, 61108
United States
Recruiting Richard Nora 815-227-2273
Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville, North Carolina, 28805
United States
Recruiting John Lucke 828-299-2540
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Marc Ernstoff 603-650-5534
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Michael Perry 573-882-4979
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Thomas Lad 312-996-2046
Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego, California, 92161
United States
Recruiting Saeeda Kirmani 619-552-8585 ext. 3356
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Karen Wendling 773-834-7424
New Hanover Regional Medical Center *Recruiting*
Wilmington, North Carolina, 28402-9025
United States
Recruiting Cyrus Kotwall 910-763-4630
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Alan Lefor 310-423-5874
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting Jeffrey Kirshner 315-472-7504
Veterans Affairs Medical Center - San Francisco *Recruiting*
San Francisco, California, 94121
United States
Recruiting Patricia Cornett 415-221-4810 ext. 3423
West Suburban Center for Cancer Care *Recruiting*
River Forest, Illinois, 60305
United States
Recruiting John Showel 708-763-2700
Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis, Minnesota, 55417
United States
Recruiting Vicki Morrison 612-725-2000 ext. 4135
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting David Hurd 336-716-2088
Barnes-Jewish Hospital *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Nancy Bartlett 314-747-3000
Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting Chitha Hulugalle 702-696-3000
CCOP - North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Vincent Vinciguerra 516-562-8915
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
CCOP - Mount Sinai Medical Center *Recruiting*
Miami, Florida, 33140
United States
Recruiting Rogerio Lilenbaum 305-674-2625
Martha Jefferson Hospital *Recruiting*
Charlottesville, Virginia, 22902
United States
Recruiting Stefan Gorsch 434-982-8410
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Scott Wadler 212-746-2844
Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke, Virginia, 24014
United States
Recruiting Paul Richards 540-982-0237
NorthEast Oncology Associates *Recruiting*
Concord, North Carolina, 28025
United States
Recruiting James Wall 704-783-1370
Vermont Cancer Center at University of Vermont *Recruiting*
Burlington, Vermont, 05401-3498
United States
Recruiting Hyman Muss 802-847-3827
Green Mountain Oncology Group *Recruiting*
Bennington, Vermont, 05201
United States
Recruiting L. Maurer 802-442-1290
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Daniel Budman 516-562-8958
Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C., District of Columbia, 20422
United States
Recruiting Steven Krasnow 202-745-8178
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Alan Venook 800-888-8664
Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Atif Hussein 954-986-6363
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Clara Bloomfield 614-293-7518
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
Additional Information:
Study ID Numbers: CDR0000069300; CALGB-30105
Study Start Date:
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033553
Other Bronchoalveolar Cell Lung Cancer Studies:
1. Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
2. Combination Chemotherapy Plus Radiation Therapy With or Without Gefitinib in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
3. Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer
4. Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
5. Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer
Related Studies:
Other bronchoalveolar cell lung cancer Clinical Trials
Other Iowa Clinical Trials
Other Iowa City Clinical Trials
Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
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