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Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer Clinical research trials and Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer. Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer  Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer
Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer
For Condition: Hypopharyngeal Cancer,lip and oral cavity cancer,Laryngeal Cancer,Oropharyngeal Cancer
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy is more effective for head and neck cancer. PURPOSE: Randomizedphase III trial to compare two different radiation therapy regimens combined with cisplatin in treating patients who have stage III or stage IV head and neck cancer.
Details: OBJECTIVES: - Compare overall survival of patients with stage III or IV squamous cell carcinoma of the head and neck treated with conventional vs accelerated radiotherapy and concurrent cisplatin. - Compare local-regional control of disease and disease-free rates in patients treated with these regimens. - Compare the acute and late toxicity of these regimens in these patients. - Compare quality of life, perception of side effects, and performance status of patients treated with these regimens. - Determine whether epidermal growth factor receptor and cyclo-oxygenase-2 expressions are independent prognostic markers in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor site (larynx vs other), nodal stage (N0 vs N1 or N2a or N2b vs N2c or N3), and Zubrod performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo standard fractionation radiotherapy 5 days a week for 7 weeks. Patients also receive cisplatin IV on days 1, 22, and 43. - Arm II: Patients undergo accelerated fractionation radiotherapy 5 days a week for 3.5 weeks and then twice a day, 5 days a week, for 2.5 weeks. Patients also receive cisplatin IV on days 1 and 22. Quality of life is assessed at baseline, during one of the last 2 weeks of treatment, at 3 and 12 months, and then annually for 4 years. Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 480 patients (240 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx - Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0) - No metastases below the clavicle or more distant by clinical exam or radiology PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Absolute granulocyte count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - ALT or AST no greater than 2 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 50 mL/min - Calcium normal Cardiovascular - No symptomatic coronary artery disease (angina) - No myocardial infarction within the past 6 months Other - No other invasive malignancy within the past 3 years except nonmelanoma skin cancer - No simultaneous primary tumors - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the head and neck except radioactive iodine therapy Surgery - No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease - No radical or modified neck dissection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
K.Ang, Study Chair, M.D. Anderson Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Bruce Minsky 212-639-6817
Saint Agnes Cancer Center *Recruiting*
Fresno, California, 93720
United States
Recruiting Madhu John 209-450-5500
Baton Rouge General Medical Center *Recruiting*
Baton Rouge, Louisiana, 70821-2511
United States
Recruiting Contact Person 225-387-7000
CCOP - North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Sophie Turner 516-562-4815
Monmouth Medical Center *Recruiting*
Long Branch, New Jersey, 07740-6395
United States
Recruiting Smitha Gollamudi 732-923-6890
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Chung-Taik Chung 315-464-5276
CCOP - Mount Sinai Medical Center *Recruiting*
Miami, Florida, 33140
United States
Recruiting Michael Samuels 305-674-2625
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Benjamin Movsas 215-728-3631
Ella Milbank Foshay Cancer Center at Jupiter Medical Center *Recruiting*
Jupiter, Florida, 33458
United States
Recruiting Contact Person 561-747-2234
Elkhart General Hospital *Recruiting*
Elkhart, Indiana, 46514
United States
Recruiting Contact Person 574-294-2621
Michiana Hematology-Oncology - Elkhart *Recruiting*
Elkhart, Indiana, 46514
United States
Recruiting Contact Person 219-389-0414
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Jerome Landry 404-778-5180
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting Contact Person 864-560-6747
University of Utah Health Sciences Center *Recruiting*
Salt Lake City, Utah, 84132
United States
Recruiting Cherie Hayostek 801-585-3593
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
LDS Hospital *Recruiting*
Salt Lake City, Utah, 84143
United States
Recruiting William Sause 801-408-1146
Mercy Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15219
United States
Recruiting Michael Dougherty 412-232-7862
Medical Center/John B. Amos Community Cancer Center *Recruiting*
Columbus, Georgia, 31901
United States
Recruiting Douglas Ciuba 706-571-1050
Good Samaritan Hospital *Recruiting*
Dayton, Ohio, 45406-1891
United States
Recruiting Contact Person 937-278-2612
Fox Valley Hematology and Oncology *Recruiting*
Appleton, Wisconsin, 54911
United States
Recruiting Contact Person 920-749-1171
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
Saint John Regional Hospital *Recruiting*
Saint John, New Brunswick, E2L 4L2
Canada
Recruiting John Carson 506-648-6884
MD Anderson Cancer Center Orlando *Recruiting*
Orlando, Florida, 32806-2134
United States
Recruiting Alan Forbes 407-643-3800
Ingalls Memorial Hospital *Recruiting*
Harvey, Illinois, 60426
United States
Recruiting Robert Share 708-915-6620
Fox Chase Cancer Center at St. Francis Medical Center *Recruiting*
Trenton, New Jersey, 08629
United States
Recruiting Jo Chalal 609-599-5179
Wayne Memorial Hospital, Inc. *Recruiting*
Goldsboro, North Carolina, 27533
United States
Recruiting Contact Person 919-736-1110
Harrington Cancer Center *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting John Gwozdz 806-359-4673 ext. 275
St. Elizabeth Medical Center *Recruiting*
Edgewood, Kentucky, 41017
United States
Recruiting Michael Cross 859-344-2238
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Contact Person 504-568-4785
Leavey Cancer Center at Northridge Hospital Medical Center *Recruiting*
Northridge, California, 91328
United States
Recruiting Contact Person 818-885-8500
Radiation Oncology Center - Sacramento *Recruiting*
Sacramento, California, 95816
United States
Recruiting Christopher Jones 916-646-8300
Genesys Regional Medical Center *Recruiting*
Grand Blanc, Michigan, 48439-8066
United States
Recruiting Contact Person 810-606-5000
Mobile Infirmary Medical Center *Recruiting*
Mobile, Alabama, 36652-2144
United States
Recruiting Contact Person 251-435-2400
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78284-7811
United States
Recruiting Tony Eng 210-616-5648
Mary Bird Perkins Cancer Center *Recruiting*
Baton Rouge, Louisiana, 70809
United States
Recruiting Kenneth Lo 225-767-0847
St. John Macomb Hospital *Recruiting*
Warren, Michigan, 48093-3494
United States
Recruiting Contact Person 586-573-5951
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Christopher Koprowski 302-733-1830
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Middletown Regional Hospital *Recruiting*
Middletown, Ohio, 45044
United States
Recruiting Contact Person 513-424-2111
Dixie Regional Medical Center *Recruiting*
St. George, Utah, 84770
United States
Recruiting Ray Richards 801-688-4175
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting Contact Person 602-274-4484
LaPorte Hospital *Recruiting*
LaPorte, Indiana, 46350-0250
United States
Recruiting Contact Person 219-326-1234
University of Miami Sylvester Cancer Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Arnold Markoe 305-243-4319
Baptist Hospital of Miami *Recruiting*
Miami, Florida, 33256-2110
United States
Recruiting Andre Abitbol 305-596-6566
Rutherford Hospital *Recruiting*
Rutherfordton, North Carolina, 28139-0000
United States
Recruiting Contact Person 828-286-5000
Cancer Research Center at Boston Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Steven Lane 617-638-7070
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital *Recruiting*
Ft. Lauderdale, Florida, 33308
United States
Recruiting Contact Person 954-776-3126
Veterans Affairs Medical Center - Milwaukee (Zablocki) *Recruiting*
Milwaukee, Wisconsin, 53295
United States
Recruiting Roger Byhardt 414-384-2000 ext. 2585
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting David Hornback 800-284-7370
Seton Cancer Institute - West Branch *Recruiting*
West Branch, Michigan, 48661
United States
Recruiting Contact Person 989-343-3600
Grady Memorial Hospital *Recruiting*
Atlanta, Georgia, 30303
United States
Recruiting Contact Perso 404-616-4307
Marshfield Clinic *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Warren Olds 715-387-7637
Memorial Regional Cancer Center at Memorial Regional Hospital *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Contact Person 954-985-3443
Broward General Medical Center *Recruiting*
Ft. Lauderdale, Florida, 33316
United States
Recruiting Contact Person 954-355-5365
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Minesh Mehta 608-263-8500
Saint Joseph Regional Medical Center *Recruiting*
South Bend, Indiana, 46634-1935
United States
Recruiting Contact Person 574-237-7111
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905-0001
United States
Recruiting Michael Haddock 507-284-2511
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611-3013
United States
Recruiting William Small 312-926-6810
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-0385
United States
Recruiting William Mendenhall 352-265-0287
Tulane University School of Medicine *Recruiting*
New Orleans, Louisiana, 70112-2699
United States
Recruiting Ellen Zakris 504-568-5151
Pocono Cancer Center *Recruiting*
East Stroudsburg, Pennsylvania, 18301
United States
Recruiting Michael Greenberg 570-476-3488
Community Medical Center *Recruiting*
Toms River, New Jersey, 08755
United States
Recruiting Bong Chang 732-557-8148
All Saints Cancer Center at All Saints Healthcare *Recruiting*
Racine, Wisconsin, 53405
United States
Recruiting James Taylor 262-687-5000
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha, Nebraska, 68114-4199
United States
Recruiting James Wheeler 402-354-4104
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center *Recruiting*
La Crosse, Wisconsin, 54601
United States
Recruiting Philip Doescher 608-782-7300 ext. 2588
Nova Scotia Cancer Centre *Recruiting*
Halifax, Nova Scotia, B3H 1V7
Canada
Recruiting Robert Rutledge 902-473-6096
South Jersey Regional Cancer Center *Recruiting*
Millville, New Jersey, 08332
United States
Recruiting Joseph Fanelle 856-293-2910
Greene Memorial Hospital *Recruiting*
Xenia, Ohio, 45385
United States
Recruiting Contact Person 937-376-6896
Oconomowoc Memorial Hospital *Recruiting*
Oconomowoc, Wisconsin, 53066
United States
Recruiting Contact Person 414-569-0669
Anderson Area Cancer Center *Recruiting*
Anderson, South Carolina, 29621-5705
United States
Recruiting Contact Person 800-613-5631
St. Joseph's Regional Health System *Recruiting*
Stockton, California, 95204
United States
Recruiting Henry Wong 209-467-6560
Natalie Warren Bryant Cancer Center *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting Contact Person 918-491-5878
Waukesha Memorial Hospital Regional Cancer Center *Recruiting*
Waukesha, Wisconsin, 53188
United States
Recruiting Wingate Clapper 262-928-2439
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Michael Zurenko 864-241-6251
Yakima Valley Memorial Hospital *Recruiting*
Yakima, Washington, 98902
United States
Recruiting Sean Cleary 509-574-3500
Grandview Hospital *Recruiting*
Dayton, Ohio, 45405
United States
Recruiting Contact Person 937-226-3200
Wendt Regional Cancer Center of Finley Hospital *Recruiting*
Dubuque, Iowa, 52001
United States
Recruiting Thomas Lally 319-589-2468
West Michigan Cancer Center *Recruiting*
Kalamazoo, Michigan, 49007
United States
Recruiting Contact Person 616-373-7488
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting Contact Person 916-734-5800
Memorial Hospital of South Bend *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Contact Person 574-234-9041
Additional Information:
Study ID Numbers: CDR0000257233; RTOG-0129,RTOG-DEV-1069,RTOG-H-0129
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047008
Other Oropharyngeal Cancer Studies:
1. Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
2. Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia
3. Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
4. Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
5. Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer
Related Studies:
Other Oropharyngeal Cancer Clinical Trials
Other California Clinical Trials
Other Northridge Clinical Trials
Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer
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