Spots Global Cancer Trial Database for Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
Official Title: Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study
Study ID: NCT00274937
Conditions
Study Description
Brief Summary: This phase III trial is studying how well radiation therapy, amifostine, and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with amifostine and chemotherapy may kill more tumor cells.
Detailed Description: PRIMARY OBJECTIVES: I. Determine the response rate, overall survival, and event-free survival of children with advanced nasopharyngeal carcinoma who are treated with induction chemotherapy followed by concurrent chemoradiotherapy and amifostine. SECONDARY OBJECTIVES: I. Characterize the role of Epstein-Barr virus (EBV) in the pathogenesis of nasopharyngeal carcinoma in children. II. Investigate the predictive value of the detection of EBV DNA in the peripheral blood of children with nasopharyngeal carcinoma. III. Determine the incidence of NUT rearrangements in childhood nasopharyngeal carcinoma. IV. Determine the radioprotective effect of amifostine when given daily prior to radiation therapy. OUTLINE: This is a nonrandomized, multicenter study. Patients are stratified according to stage of disease (I or IIA \[stratum I\] vs IIB-IV \[stratum II\]). STRATUM I: Patients undergo radiotherapy 5 days a week for 8 weeks. Patients also receive amifostine subcutaneously on the same days they undergo radiotherapy. STRATUM II: INDUCTION THERAPY (weeks 1-9): Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease proceed to consolidation therapy. CONSOLIDATION THERAPY (weeks 10-18): Patients undergo radiotherapy and receive amifostine as in stratum I. Patients also receive cisplatin IV over 6 hours on days 1 and 22 (2 courses). After completion of study treatment, patients are followed periodically for 10 years.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of Alabama, Birmingham, Alabama, United States
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Banner University Medical Center - Tucson, Tucson, Arizona, United States
Arkansas Children's Hospital, Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center, Downey, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Mattel Children's Hospital UCLA, Los Angeles, California, United States
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Valley Children's Hospital, Madera, California, United States
Kaiser Permanente-Oakland, Oakland, California, United States
Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
UCSF Medical Center-Parnassus, San Francisco, California, United States
UCSF Medical Center-Mission Bay, San Francisco, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
University of Connecticut, Farmington, Connecticut, United States
Connecticut Children's Medical Center, Hartford, Connecticut, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lee Memorial Health System, Fort Myers, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood, Florida, United States
Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Nicklaus Children's Hospital, Miami, Florida, United States
Arnold Palmer Hospital for Children, Orlando, Florida, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States
Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa, Florida, United States
Saint Mary's Hospital, West Palm Beach, Florida, United States
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Norton Children's Hospital, Louisville, Kentucky, United States
Tulane University Health Sciences Center, New Orleans, Louisiana, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
C S Mott Children's Hospital, Ann Arbor, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Ascension Saint John Hospital, Detroit, Michigan, United States
Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
Cardinal Glennon Children's Medical Center, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas, Nevada, United States
Nevada Cancer Research Foundation NCORP, Las Vegas, Nevada, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Morristown Medical Center, Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
Overlook Hospital, Summit, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
New York Medical College, Valhalla, New York, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Rainbow Babies and Childrens Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Dayton Children's Hospital, Dayton, Ohio, United States
Mercy Children's Hospital, Toledo, Ohio, United States
University of Toledo, Toledo, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
Penn State Children's Hospital, Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Saint Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Prisma Health Richland Hospital, Columbia, South Carolina, United States
BI-LO Charities Children's Cancer Center, Greenville, South Carolina, United States
Greenville Cancer Treatment Center, Greenville, South Carolina, United States
East Tennessee Childrens Hospital, Knoxville, Tennessee, United States
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
Driscoll Children's Hospital, Corpus Christi, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Primary Children's Hospital, Salt Lake City, Utah, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Children's Hospital of The King's Daughters, Norfolk, Virginia, United States
Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, United States
West Virginia University Charleston Division, Charleston, West Virginia, United States
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
Alberta Children's Hospital, Calgary, Alberta, Canada
British Columbia Children's Hospital, Vancouver, British Columbia, Canada
IWK Health Centre, Halifax, Nova Scotia, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Centre Hospitalier Universitaire de Quebec, Quebec, , Canada
Contact Details
Name: Carlos Rodriguez-Galindo
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
