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Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer Clinical research trials and Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer healthcare trials take place in many of cities 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 evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer. Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare 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 > "B" Clinical Trials Conditions > Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer  Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer
Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer
For Condition: limited stage small cell lung 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. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer. PURPOSE: Randomizedphase II/III trial to compare the effectiveness of three brain irradiation regimens in preventing brain metastases in patients who have limited-stage small cell lung cancer.
Details: OBJECTIVES: - Compare the incidence of brain metastases in patients with limited stage small cell lung cancer treated with different regimens of prophylactic cranial irradiation. - Compare the overall and disease-free survival of patients treated with these regimens. - Compare the incidence of chronic neurotoxicity in patients treated with these regimens. - Compare quality of life and late treatment sequelae of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and under vs over 60) and time since induction therapy (90 days or less vs 91-180 days vs 181-240 days). Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a week. Treatment continues for 2 weeks in the absence of unacceptable toxicity. - Arm II: Patients undergo PCI once daily 5 days a week. Treatment continues for 2.6 weeks in the absence of unacceptable toxicity. - Arm III: Patients undergo PCI twice daily 5 days a week. Treatment continues for 3.4 weeks in the absence of unacceptable toxicity. Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 3 years. Patients are followed every 6 months for 1 year and then annually for 3 years. PROJECTED ACCRUAL: A total of 264 patients will be accrued for this study within 3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed small cell lung cancer by fine needle aspiration, biopsy, or 2 positive sputa - Limited stage (I-IIIB) - Confined to 1 hemithorax - No T4 or N3 disease - Complete response after induction chemotherapy (with or without thoracic radiotherapy) - Consolidative chest radiotherapy may be initiated before study - No radiographic evidence of any of the following: - Brain metastases - Normal brain CT scan or MRI less than 1 month before study - Ipsilateral lung metastases - Malignant pleural effusion - Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray PATIENT CHARACTERISTICS: Age - Not specified Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 10.0 g/dL^ Hepatic - Not specified Renal - Not specified Pulmonary - See Disease Characteristics Other - Not pregnant or nursing - Fertile patients must use effective contraception - Neurological function class 1 or 2 - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No other serious medical or psychiatric condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - At least 1 week since prior chemotherapy - No concurrent chemotherapy during or for 1 week after radiotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior external beam radiotherapy to the head or neck, including stereotactic radiotherapy - Concurrent thoracic radiotherapy allowed Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AaronWolfson, Study Chair, Sylvester Cancer Center
New York Methodist Hospital *Recruiting*
Brooklyn, New York, 11215
United States
Recruiting Sameer Rafla-Demetrious 718-780-3677
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting David Brachman 602-274-4484
Hulston Cancer Center at Cox Medical Center South *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting Contact Person 417-269-5257
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha, Nebraska, 68114-4199
United States
Recruiting James Wheeler 402-354-4104
Cottonwood Hospital Medical Center *Recruiting*
Murray, Utah, 84107
United States
Recruiting Contact Person 801-314-5300
Cooper Cancer Institute at Cooper University Hospital *Recruiting*
Voorhees, New Jersey, 08043
United States
Recruiting Contact Person 800-826-6737
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Minesh Mehta 608-263-8500
St. Vincent Hospital *Recruiting*
Green Bay, Wisconsin, 54307-3508
United States
Recruiting Gregory Cooley 414-433-8184
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Christopher Koprowski 302-733-1830
South Jersey Regional Cancer Center *Recruiting*
Millville, New Jersey, 08332
United States
Recruiting Joseph Fanelle 856-293-2910
McKay-Dee Hospital Center *Recruiting*
Ogden, Utah, 84403
United States
Recruiting Contact Person 801-627-2800
CCOP - Bay Area Tumor Institute *Recruiting*
Oakland, California, 94609-3305
United States
Recruiting Brenda Shank 510-456-8570
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center *Recruiting*
Grand Junction, Colorado, 81502-1628
United States
Recruiting Douglas Rock 970-244-2442
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Contact Person 888-600-4822
LDS Hospital *Recruiting*
Salt Lake City, Utah, 84143
United States
Recruiting William Sause 801-408-1146
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center *Recruiting*
La Crosse, Wisconsin, 54601
United States
Recruiting Philip Doescher 608-782-7300 ext. 2588
Cancer Care Center, Incorporated *Recruiting*
Salem, Ohio, 44460
United States
Recruiting Contact Person 330-375-3557
Pomona Valley Hospital Medical Center *Recruiting*
Pomona, California, 91767
United States
Recruiting Contact Person 909-865-9500
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
Reading Hospital and Medical Center *Recruiting*
Reading, Pennsylvania, 19612-6052
United States
Recruiting Albert Yuen 610-988-8067
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-5671
United States
Recruiting A.J. Cmelak 615-322-2555
Akron City Hospital *Recruiting*
Akron, Ohio, 44304
United States
Recruiting William Demas 330-375-3557
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting Judith Figura 412-578-1923
University Cancer Center at University of Washington Medical Center *Recruiting*
Seattle, Washington, 98195-6043
United States
Recruiting David Schwartz 206-768-5356
St. Joseph's Regional Health System *Recruiting*
Stockton, California, 95204
United States
Recruiting Henry Wong 209-467-6560
Cancer Treatment Center *Recruiting*
Wooster, Ohio, 44691
United States
Recruiting Contact Person 330-262-6060
Fox Chase Cancer Center at St. Francis Medical Center *Recruiting*
Trenton, New Jersey, 08629
United States
Recruiting Jo Chalal 609-599-5179
Veterans Affairs Medical Center - Milwaukee (Zablocki) *Recruiting*
Milwaukee, Wisconsin, 53295
United States
Recruiting Roger Byhardt 414-384-2000 ext. 2585
Delaware County Memorial Hospital *Recruiting*
Drexel Hill, Pennsylvania, 19026
United States
Recruiting Rachelle Lanciano 610-284-8240
Bon Secours - St. Mary's Hospital *Recruiting*
Richmond, Virginia, 23226
United States
Recruiting George Trivette 804-281-8350
Utah Valley Regional Medical Center - Provo *Recruiting*
Provo, Utah, 84604
United States
Recruiting Tarlton Blair 801-373-7850 ext. 2480
Nova Scotia Cancer Centre *Recruiting*
Halifax, Nova Scotia, B3H 1V7
Canada
Recruiting Robert Rutledge 902-473-6096
University of Miami Sylvester Cancer Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Arnold Markoe 305-243-4319
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Michael Zurenko 864-241-6251
Centre Hospitalier Universitaire de Quebec *Recruiting*
Quebec City, Quebec, G1R 2J6
Canada
Recruiting Andre Fortin 418-691-5264
Nanticoke Memorial Hospital *Recruiting*
Seaford, Delaware, 19973
United States
Recruiting Contact Person 302-629-0260
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Eugen Hug 603-650-6600
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting N. Mariados 315-472-7504
Sarasota Radiation and Medical Oncology Center *Recruiting*
Sarasota, Florida, 34233
United States
Recruiting W. Dickens 941-924-8700
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Mohan Suntharalingam 410-328-6080
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Denver, Colorado, 80010
United States
Recruiting Rachel Rabinovitch 720-848-0116
St. Luke's Hospital Cancer Center *Recruiting*
Bethlehem, Pennsylvania, 18015
United States
Recruiting Nimisha Deb 610-954-4300
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Daniel Petereit 605-719-2360
Dixie Regional Medical Center *Recruiting*
St. George, Utah, 84770
United States
Recruiting Ray Richards 801-688-4175
Yale Comprehensive Cancer Center *Recruiting*
New Haven, Connecticut, 06520-8040
United States
Recruiting Jonathan Knisely 203-785-5702
West Michigan Cancer Center *Recruiting*
Kalamazoo, Michigan, 49007
United States
Recruiting Contact Person 616-373-7488
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0010
United States
Recruiting Howard Sandler 734-936-9338
Wayne Memorial Hospital, Inc. *Recruiting*
Goldsboro, North Carolina, 27533
United States
Recruiting Contact Person 919-736-1110
Methodist Medical Center of Illinois *Recruiting*
Peoria, Illinois, 61636
United States
Recruiting Revathi Swaminathan 309-672-5700
Trinity Cancer Care Center *Recruiting*
Minot, North Dakota, 58701
United States
Recruiting Kevin Collins 701-857-3535
CCOP - Scott and White Hospital *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting Cathy Clausen 309-636-3605
Mercy Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15219
United States
Recruiting Michael Dougherty 412-232-7862
Additional Information:
Study ID Numbers: CDR0000258668; RTOG-0212
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057746
Other Limited Stage Small Cell Lung Cancer Studies:
1. Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer
2. Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer
3. Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer
4. Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
5. Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer
Related Studies:
Other limited stage small cell lung cancer Clinical Trials
Other Florida Clinical Trials
Other Sarasota Clinical Trials
Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer
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