Pancreatic Cancer |
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Clinical Trial: Radiation Therapy Plus Paclitaxel in Treating Patients With Nonmetastatic, Unresectable Pancreatic Cancer
This study is no longer recruiting patients.
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in treating patients who have nonmetastatic, unresectable pancreatic cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage III pancreatic cancer adenocarcinoma of the pancreas recurrent pancreatic cancer stage I pancreatic cancer stage II pancreatic cancer | Drug: paclitaxel | Phase II |
MedlinePlus related topics: Pancreatic Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of External Irradiation and Weekly Paclitaxel in Patients with Nonmetastatic, Unresectable Pancreatic Cancer
Study start: November 1998
OBJECTIVES: I. Determine the response rate of patients with nonmetastatic, unresectable pancreatic cancer receiving external beam irradiation and weekly paclitaxel.
II. Determine the median survival after this treatment in these patients.
III. Evaluate the acute and late treatment morbidity of paclitaxel in these patients.
IV. Correlate p53 status with treatment response to this treatment in this patient population.
PROTOCOL OUTLINE: This is a open label, multicenter study.
Patients are highly recommended to undergo laparoscopic surgical staging prior to protocol to exclude peritoneal and hepatic metastases.
Patients receive paclitaxel IV over 3 hours weekly for 6 weeks beginning on day 1 followed 1.5 hours later by external beam radiotherapy daily 5 days a week for 5.5 weeks beginning on day 1.
All patients are restaged with an abdominal CT scan 6 weeks following completion of chemoradiotherapy. If there is marked response to treatment at this time, curative surgery may be attempted at the discretion of the attending surgeon.
Patients are followed every 3 months for 1 year, every 4 months for the second year, every 6 months for years 3-5, and annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients will be accrued into this study over 12 months.
Eligibility
Ages Eligible for Study: 18 Years and above
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically confirmed nonmetastatic, unresectable pancreatic adenocarcinoma; No evidence of metastatic disease in the major viscera and no peritoneal seeding
- Residual disease after resection (R-1 or -2 micro- and macroscopic residual) eligible if measurable disease on the post operative CT or MRI scan
- Recurrent disease following radical surgery is eligible
- All malignant disease must be encompassable within a single irradiation field
- Must be a radiographically assessable disease; CT with 5 mm cuts or spiral CT
--Prior/Concurrent Therapy--
- Biologic therapy: Not specified
- Chemotherapy: No prior paclitaxel; At least 4 weeks since prior gemcitabine; No other prior chemotherapy
- Endocrine therapy: Not specified
- Radiotherapy: No prior radiotherapy to the planned field
- Surgery: See Disease Characteristics
--Patient Characteristics--
- Age: 18 and over
- Performance status: Karnofsky 60-100%
- Life expectancy: Not specified
- Hematopoietic: Granulocyte count at least 1,800/mm3; Platelet count at least 100,000/mm3
- Hepatic: Bilirubin no greater than 2 mg/dL; Biliary system stented
- Renal: Creatinine less than 3.0 mg/dL OR Creatinine clearance at least 40 mL/min
- Other: If patients have biliary or gastroduodenal obstruction, they must have drainage prior to starting chemoradiation; Oral intake of at least 1,500 calories per day; No significant infection or other coexistent medical condition
Location Information
Alabama
Alabama Oncology, LLC, Montgomery, Alabama, 36106-2801, United States
Huntsville Hospital System, Huntsville, Alabama, 35801, United States
MBCCOP - University of South Alabama, Mobile, Alabama, 36688, United States
Radiation Oncology Associates of West Alabama, Tuscallosa, Alabama, 35401, United States
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, 35294, United States
Urology Associates - Mobile AL, Mobile, Alabama, 36640, United States
Veterans Affairs Medical Center - Birmingham, Birmingham, Alabama, 35233, United States
Alaska
Providence Cancer Therapy Center, Anchorage, Alaska, 99508, United States
Arizona
Arizona Cancer Center, Tucson, Arizona, 85724, United States
California
Beckman Research Institute, City of Hope, Duarte, California, 91010, United States
California Cancer Center, Fresno, California, 93720, United States
Cancer Care Center, Pomona, California, 91767, United States
CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, 95403, United States
David Grant Medical Center, Travis Air Force Base, California, 94535, United States
Glendale Memorial Hospital and Health Center, Glendale, California, 91204, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States
Kaiser Permanente Medical Center - Los Angeles, Los Angeles, California, 90027, United States
Loma Linda University Medical Center, Loma Linda, California, 92354, United States
Mercy Medical Center - Redding, Redding, California, 96099-6009, United States
Mount Diablo Medical Center, Concord, California, 94524-4110, United States
Providence Saint Joseph Medical Center - Burbank, Burbank, California, 91505, United States
Radiation Oncology Center - Sacramento, Sacramento, California, 95816, United States
Radiation Oncology Center - Walnut Creek, Walnut Creek, California, 94598, United States
Saint Agnes Cancer Center, Fresno, California, 93720, United States
Santa Cruz Radiation Oncology Medical Group, Inc., Santa Cruz, California, 95065, United States
Stanford University, Stanford, California, 94305, United States
Sutter Health Western Division Cancer Research Group, Greenbrae, California, 94904, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, 94115-0128, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, 90033-0800, United States
Veterans Affairs Medical Center - Long Beach, Long Beach, California, 90822, United States
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, 94553, United States
Colorado
Memorial Hospital Cancer Center, Colorado Springs, Colorado, 80909, United States
University of Colorado Cancer Center, Denver, Colorado, 80262, United States
Connecticut
Bridgeport Hospital, Bridgeport, Connecticut, 06610, United States
Whittingham Cancer Center, Norwalk, Connecticut, 06856, United States
Delaware
CCOP - Christiana Care Health Services, Wilmington, Delaware, 19899, United States
District of Columbia
Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5000, United States
Florida
Baptist Hospital of Miami, Miami, Florida, 33176-2197, United States
Bayfront Medical Center, Saint Petersburg, Florida, 33701, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States
Florida Radiation Oncology Group, Orange Park, Florida, 32073, United States
Gulf Coast Cancer Treatment Center, Panama City, Florida, 32405-4587, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, 33612, United States
Halifax Medical Center, Daytona Beach, Florida, 32114, United States
Health First Holmes Regional Medical Center, Melbourne, Florida, 32901, United States
Lykes Center for Radiation Therapy, Clearwater, Florida, 33757-0210, United States
MD Anderson Cancer Center Orlando, Orlando, Florida, 32806, United States
Radiation Therapy Associates - Fort Myers, Fort Myers, Florida, 33901, United States
Sylvester Cancer Center, University of Miami, Miami, Florida, 33136, United States
University of Florida Health Science Center, Gainesville, Florida, 32610-0296, United States
West Florida Cancer Institute - Pensacola, Pensacola, Florida, 32514, United States
Georgia
CCOP - Atlanta Regional, Atlanta, Georgia, 30342-1701, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, 30322, United States
InterCommunity Cancer Center at Rome, Rome, Georgia, 30161, United States
South Georgia Medical Center, Valdosta, Georgia, 31603, United States
Illinois
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States
CCOP - Central Illinois, Springfield, Illinois, 62526, United States
Ingalls Memorial Hospital, Harvey, Illinois, 60426, United States
Loyola University Medical Center, Maywood, Illinois, 60153, United States
Lutheran General Cancer Care Center, Park Ridge, Illinois, 60068, United States
Methodist Medical Center of Illinois, Peoria, Illinois, 61636, United States
Northwestern Memorial Hospital, Chicago, Illinois, 60611, United States
University of Chicago Cancer Research Center, Chicago, Illinois, 60637, United States
Indiana
Ball Memorial Hospital, Muncie, Indiana, 47303-3499, United States
Clarion Health Partners Inc., Indianapolis, Indiana, 46206-1367, United States
Community Hospitals of Indianapolis - Regional Cancer Center, Indianapolis, Indiana, 46219, United States
Memorial Hospital of South Bend, South Bend, Indiana, 46601, United States
St. John's Medical Center, Anderson, Indiana, 46016, United States
St. Joseph's Radiation Oncology Center, South Bend, Indiana, 46617, United States
Iowa
University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States
Wendt Regional Cancer Center of Finley Hospital, Dubuque, Iowa, 52001, United States
Kentucky
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, 40536-0084, United States
James Graham Brown Cancer Center, Louisville, Kentucky, 40202, United States
Louisville Radiation Oncology, Louisville, Kentucky, 40215, United States
Medical Center at Bowling Green, Bowling Green, Kentucky, 42102, United States
Merle M. Mahr Cancer Center, Madisonville, Kentucky, 42431, United States
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, 40511-1093, United States
Western Baptist Hospital, Paducah, Kentucky, 42001, United States
Louisiana
CCOP - Ochsner, New Orleans, Louisiana, 70121, United States
East Jefferson General Hospital, Metairie, Louisiana, 70011, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, 70809, United States
MBCCOP - LSU Medical Center, New Orleans, Louisiana, 70112, United States
Romagosa Radiation Oncology Center, Lafayette, Louisiana, 70501, United States
Maine
Maine Medical Center, Portland, Maine, 04102, United States
Maryland
Anne Arundel Oncology Center, Annapolis, Maryland, 21401, United States
Greater Baltimore Medical Center and Cancer Center, Baltimore, Maryland, 21204, United States
Harbor Hospital Center, Baltimore, Maryland, 21225, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, 21287, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, 21201, United States
Radiation Oncology Affiliates of Maryland, P.A., Baltimore, Maryland, 21237, United States
Massachusetts
Cape Cod Hospital, Hyannis, Massachusetts, 02601, United States
Joint Center for Radiation Therapy, Boston, Massachusetts, 02215, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, 02114, United States
Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, 48106, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-3731, United States
Henry Ford Hospital, Detroit, Michigan, 48202, United States
Hurley Medical Center, Flint, Michigan, 48503, United States
Marquette General Hospital, Marquette, Michigan, 49855, United States
St. Mary's Medical Center, Saginaw, Michigan, 48601, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0752, United States
Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan, 48105, United States
Minnesota
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States
Missouri
Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States
CCOP - Kansas City, Kansas City, Missouri, 64131, United States
CCOP - Ozarks Regional, Springfield, Missouri, 65807, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, 65203, United States
Mallinckrodt Institute of Radiology, Saint Louis, Missouri, 63110, United States
St. Louis University Health Sciences Center, Saint Louis, Missouri, 63110-0250, United States
Veterans Affairs Medical Center - Saint Louis, Saint Louis, Missouri, 63106, United States
Montana
CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States
Nebraska
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, 68131, United States
Methodist Cancer Center - Omaha, Omaha, Nebraska, 68114, United States
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States
New Hampshire
Elliot Regional Cancer Center, Manchester, New Hampshire, 03103, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, 03756, United States
New Jersey
Community Medical Center, Toms River, New Jersey, 08755, United States
Elizabeth General Medical Center - West, Elizabeth, New Jersey, 07201, United States
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County, Mount Holly, New Jersey, 08060, United States
John F. Kennedy Medical Center, Edison, New Jersey, 08818, United States
South Jersey Hospital - Millville, Millville, New Jersey, 08332, United States
St. Francis Medical Center, Trenton, New Jersey, 08629, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, 07018-1095, United States
New Mexico
Saint Joseph Medical Center, Albuquerque, New Mexico, 87102, United States
New York
Albert Einstein Comprehensive Cancer Center, Bronx, New York, 10461, United States
Cancer Center of Albany Medical Center, Albany, New York, 12208, United States
CCOP - North Shore University Hospital, Manhasset, New York, 11030, United States
Champlain Valley Physicians Hospital Medical Center, Plattsburgh, New York, 12901, United States
Genesee Hospital - Rochester, Rochester, New York, 14607, United States
Kaplan Cancer Center, New York, New York, 10016, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States
New York Medical College, Valhalla, New York, 10595, United States
New York Methodist Hospital, Brooklyn, New York, 11215-3609, United States
State University of New York Health Science Center at Brooklyn, Brooklyn, New York, 11203, United States
University of Rochester Cancer Center, Rochester, New York, 14642, United States
Vassar Brothers Hospital, Poughkeepsie, New York, 12601, United States
Veterans Affairs Medical Center - Albany, Albany, New York, 12208, United States
North Carolina
CCOP - Southeast Cancer Control Consortium, Winston Salem, North Carolina, 27104-4241, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston Salem, North Carolina, 27157-1082, United States
East Carolina University School of Medicine, Greenville, North Carolina, 27858-4354, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, 27599-7295, United States
North Dakota
Meritcare Roger Maris Cancer Center, Fargo, North Dakota, 58122, United States
UNI-MED Medical Center, Minot, North Dakota, 58701, United States
Ohio
Akron City Hospital, Akron, Ohio, 44309, United States
Akron General Medical Center, Akron, Ohio, 44302, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, 43210, United States
CCOP - Columbus, Columbus, Ohio, 43206, United States
CCOP - Dayton, Kettering, Ohio, 45429, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, 43623-3456, United States
Christ Hospital, Cincinnati, Ohio, 45219, United States
Ireland Cancer Center, Cleveland, Ohio, 44106-5065, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, 45428, United States
Oklahoma
St. John Medical Center, Tulsa, Oklahoma, 74104, United States
Oregon
CCOP - Columbia River Program, Portland, Oregon, 97213, United States
Samaritan Regional Cancer Center, Corvallis, Oregon, 97339, United States
Pennsylvania
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, 19141, United States
Allegheny University Hospitals- Hahnemann, Philadelphia, Pennsylvania, 19102-1192, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, 19096, United States
Delaware County Memorial Hospital, Drexel Hill, Pennsylvania, 19026, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States
Grand View Hospital, Sellersville, Pennsylvania, 18960, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, 19107, United States
Mercy Catholic Medical Center, Mercy Fitzgerald Divison, Darby, Pennsylvania, 19023, United States
Mercy Hospital Cancer Center - Scranton, Scranton, Pennsylvania, 18501, United States
Penn State Geisinger Cancer Center, Hershey, Pennsylvania, 17033, United States
Penn State Geisinger Medical Center, Danville, Pennsylvania, 17822-2001, United States
Reading Hospital and Medical Center, Reading, Pennsylvania, 19612-6052, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15213, United States
Veterans Affairs Medical Center - Philadelphia, Philadelphia, Pennsylvania, 19104, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, 15224, United States
Wilkes Barre General Hospital, Wilkes Barre, Pennsylvania, 18764, United States
York Hospital, York, Pennsylvania, 17315, United States
Rhode Island
Lifespan: The Miriam Hospital, Providence, Rhode Island, 02906, United States
Roger Williams Medical Center/Brown University, Providence, Rhode Island, 02908-4735, United States
South Carolina
CCOP - Greenville, Greenville, South Carolina, 29615, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States
Medical University of South Carolina, Charleston, South Carolina, 29425-0721, United States
Tennessee
Baptist Regional Cancer Center - Knoxville, Knoxville, Tennessee, 37901, United States
CCOP - Baptist Cancer Institute, Memphis, Tennessee, 38117, United States
Jackson-Madison County General Hospital, Jackson, Tennessee, 38301, United States
University of Tennessee, Memphis Cancer Center, Memphis, Tennessee, 38163, United States
Vanderbilt Cancer Center, Nashville, Tennessee, 37232-6838, United States
Texas
Bayshore Medical Center, Pasadena, Texas, 77504, United States
Julie and Ben Rogers Cancer Institute, Beaumont, Texas, 77701, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, 77030, United States
University of Texas Medical Branch, Galveston, Texas, 77555-1329, United States
Wilford Hall - 59th Medical Wing, Lackland Air Force Base, Texas, 78236-5300, United States
Utah
Dixie Regional Medical Center, Saint George, Utah, 84770, United States
LDS Hospital, Salt Lake City, Utah, 84143, United States
Vermont
CCOP - Southwestern Vermont Regional Cancer Center, Bennington, Vermont, 05201, United States
Green Mountain Oncology Group, Rutland, Vermont, 05701, United States
Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont, 05009, United States
Virginia
Cancer Center, University of Virginia HSC, Charlottesville, Virginia, 22908, United States
Martha Jefferson Hospital, Charlottesville, Virginia, 22901, United States
Massey Cancer Center, Richmond, Virginia, 23298-0037, United States
Naval Medical Center, Portsmouth, Portsmouth, Virginia, 23708-2197, United States
Virginia Baptist Hospital, Lynchburg, Virginia, 24503, United States
Washington
Deaconess Medical Center, Spokane, Washington, 99210-0248, United States
Swedish Hospital Tumor Institute, Seattle, Washington, 98104, United States
Virginia Mason Medical Center, Seattle, Washington, 98111, United States
Yakima Valley Memorial Hospital, Yakima, Washington, 98902, United States
West Virginia
Schiffler Oncology Center, Wheeling, West Virginia, 26003, United States
Wisconsin
Columbia Hospital, Milwaukee, Wisconsin, 53211, United States
Community Memorial Hospital, Menomonee Falls, Wisconsin, 53051, United States
Gundersen Lutheran Medical Foundation, La Crosse, Wisconsin, 54601, United States
Marshfield Clinic, Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States
Southeastern Wisconsin Regional Cancer Center, Racine, Wisconsin, 53405, United States
Southern Wisconsin Radiotherapy Center, Madison, Wisconsin, 53713, United States
St. Joseph's Hospital, Milwaukee, Wisconsin, 53210, United States
St. Luke's Medical Center, Milwaukee, Wisconsin, 53215, United States
St. Vincent Hospital, Green Bay, Wisconsin, 54307-3508, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792, United States
Veterans Affairs Medical Center - Madison, Madison, Wisconsin, 53705, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, 53295, United States
Canada, Alberta
Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada
Tom Baker Cancer Center - Calgary, Calgary, Alberta, T2N 4N2, Canada
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Island Cancer Centre, Victoria, British Columbia, V8R 1J8, Canada
Canada, New Brunswick
Doctor Leon Richard Oncology Centre, Moncton, New Brunswick, E1C 8X3, Canada
Saint John Regional Hospital, Saint John, New Brunswick, E2L 4L2, Canada
Canada, Nova Scotia
Nova Scotia Cancer Centre, Halifax, Nova Scotia, B3H 1V7, Canada
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton, Ontario, L8V 5C2, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, N6A 4L6, Canada
Kingston Regional Cancer Centre, Kingston, Ontario, K7L 5P9, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury, Sudbury, Ontario, P3E 5J1, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay, Thunder Bay, Ontario, P7A 7T1, Canada
Ottawa Regional Cancer Centre - Civic Campus, Ottawa, Ontario, K1Y 4K7, Canada
Princess Margaret Hospital, Toronto, Ontario, M5G 2M9, Canada
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, H2W-W1T8, Canada
McGill University Department of Oncology, Montreal, Quebec, H2W 1S6, Canada
Canada, Saskatchewan
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, S7N 4H4, Canada
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Publications
Rich T, Harris J, Abrams R, Erickson B, Doherty M, Paradelo J, Small W Jr, Safran H, Wanebo HJ. Phase II study of external irradiation and weekly paclitaxel for nonmetastatic, unresectable pancreatic cancer: RTOG-98-12. Am J Clin Oncol. 2004 Feb;27(1):51-6.
Record last reviewed: September 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003591
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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