Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors
17 de enero de 2018 actualizado por: Children's Oncology Group
A Phase II Study To Assess The Ability Of Neoadjuvant Chemotherapy Plus/Minus Second Look Surgery To Eliminate All Measurable Disease Prior To Radiotherapy For NGGCT
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it is no longer present by conventional imaging and tumor markers from serum and cerebrospinal fluid. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Combining different types of therapy may kill more tumor cells.
PURPOSE: This Phase II trial is studying how well neoadjuvant chemotherapy with or without surgery and with or without high dose chemotherapy and peripheral stem cell transplantation, can increase response rates prior to radiation therapy and increase progression free and overall surviving patients with newly diagnosed intracranial germ cell tumors.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
OBJECTIVES:
- Determine the response rate of patients with non-germinomatous germ cell tumors treated with neoadjuvant chemotherapy.
- Determine the progression-free survival and overall survival of patients treated with neoadjuvant chemotherapy with or without second-look surgery followed by radiotherapy with or without autologous peripheral blood stem cell transplantation (PBSCT).
- Determine whether additional complete responses can be achieved after high-dose thiotepa and etoposide with PBSCT in patients with persistently positive markers, histological evidence of residual malignant elements, or unresectable residual tumors after initial neoadjuvant chemotherapy.
- Determine patterns of recurrence in patients treated with this regimen.
- Correlate tumor marker response with radiographic and clinical measures of response, as well as findings at second-look surgery in patients with radiological evidence of residual disease.
OUTLINE:
Induction chemotherapy:
- Courses 1, 3, and 5: Patients receive carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3. Beginning on day 4, patients receive filgrastim (G-CSF) IV or subcutaneously (SC) for 10 days or until blood counts recover. Courses are 3 weeks in duration.
- Courses 2, 4, and 6: Patients receive etoposide IV over 1 hour followed by ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive G-CSF IV or SC for 10 days or until blood counts recover. Courses are 3 weeks in duration.
Patients undergo re-evaluation. Patients with a complete response (CR) go directly to radiotherapy. Approximately 3 weeks after completion of induction chemotherapy, all patients with less than a CR are encouraged to undergo second-look surgery.
After second-look surgery, patients with a CR or a partial response (PR) go directly to radiotherapy. Patients with less than a PR undergo consolidation chemotherapy with peripheral blood stem cell rescue (PBSC) followed by radiotherapy.
- Consolidation chemotherapy: Patients undergo PBSC collection. Patients receive G-CSF SC until PBSC collection is complete. Patients then receive thiotepa IV over 3 hours followed by etoposide IV over 3 hours on days -5 to -3. PBSCs are reinfused on day 0. Beginning on day 1 and continuing until blood counts recover, patients receive G-CSF SC daily.
- Radiotherapy: All patients receive radiotherapy once daily 5 days a week for 5-6 weeks beginning after recovery from induction chemotherapy or second-look surgery or within 9 weeks after PBSC reinfusion.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 80-100 patients will be accrued for this study within 36-42 months.
Tipo de estudio
Intervencionista
Inscripción (Actual)
104
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Queensland
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Brisbane, Queensland, Australia, 4029
- Royal Children's Hospital
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Victoria
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Parkville, Victoria, Australia, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australia, 6001
- Princess Margaret Hospital for Children
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Quebec, Canadá, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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British Columbia
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Vancouver, British Columbia, Canadá, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canadá, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canadá, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Toronto, Ontario, Canadá, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canadá, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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Montreal, Quebec, Canadá, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Phoenix, Arizona, Estados Unidos, 85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Estados Unidos, 90242-2814
- Southern California Permanente Medical Group
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Loma Linda, California, Estados Unidos, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Estados Unidos, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Estados Unidos, 90027
- Childrens Hospital Los Angeles
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Madera, California, Estados Unidos, 93638-8762
- Children's Hospital Central California
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Oakland, California, Estados Unidos, 94609
- Children's Hospital and Research Center Oakland
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Orange, California, Estados Unidos, 92868
- Children's Hospital of Orange County
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Sacramento, California, Estados Unidos, 95816
- Sutter Cancer Center
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San Diego, California, Estados Unidos, 92123-4282
- Rady Children's Hospital - San Diego
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San Francisco, California, Estados Unidos, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Stanford, California, Estados Unidos, 94305-5824
- Stanford Cancer Center
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Connecticut
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Farmington, Connecticut, Estados Unidos, 06360-2875
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
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Delaware
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Wilmington, Delaware, Estados Unidos, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010-2970
- Children's National Medical Center
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Florida
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Fort Myers, Florida, Estados Unidos, 33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville, Florida, Estados Unidos, 32610-0232
- University of Florida Shands Cancer Center
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Jacksonville, Florida, Estados Unidos, 32207
- Nemours Children's Clinic
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Miami, Florida, Estados Unidos, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Estados Unidos, 33155
- Miami Children's Hospital
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Orlando, Florida, Estados Unidos, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Pensacola, Florida, Estados Unidos, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg, Florida, Estados Unidos, 33701
- All Children's Hospital
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Tampa, Florida, Estados Unidos, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Estados Unidos, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Winship Cancer Institute of Emory University
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Augusta, Georgia, Estados Unidos, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago, Illinois, Estados Unidos, 60637-1470
- University of Chicago Cancer Research Center
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Park Ridge, Illinois, Estados Unidos, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Springfield, Illinois, Estados Unidos, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Estados Unidos, 46260
- St. Vincent Indianapolis Hospital
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Estados Unidos, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Michigan
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Detroit, Michigan, Estados Unidos, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids, Michigan, Estados Unidos, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Estados Unidos, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Lansing, Michigan, Estados Unidos, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, Estados Unidos, 55455
- Masonic Cancer Center at University of Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Estados Unidos, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center Cancer Center
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New Brunswick, New Jersey, Estados Unidos, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Estados Unidos, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Estados Unidos, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Estados Unidos, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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New York, New York, Estados Unidos, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, Estados Unidos, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Estados Unidos, 10595
- New York Medical College
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Akron, Ohio, Estados Unidos, 44308-1062
- Akron Children's Hospital
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Cincinnati, Ohio, Estados Unidos, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Estados Unidos, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Estados Unidos, 45404-1815
- Children's Medical Center - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Estados Unidos, 97239-3098
- Oregon Health and Science University Cancer Institute
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19134-1095
- St. Christopher's Hospital for Children
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Philadelphia, Pennsylvania, Estados Unidos, 19104-9786
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Hollings Cancer Center at Medical University of South Carolina
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38105
- St. Jude Children's Research Hospital
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Nashville, Tennessee, Estados Unidos, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Austin, Texas, Estados Unidos, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, Estados Unidos, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Estados Unidos, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Estados Unidos, 76104
- Cook Children's Medical Center - Fort Worth
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Lubbock, Texas, Estados Unidos, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Estados Unidos, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Estados Unidos, 78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Estados Unidos, 84113-1100
- Primary Children's Medical Center
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Virginia
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Norfolk, Virginia, Estados Unidos, 23507-1971
- Children's Hospital of The King's Daughters
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West Virginia
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Charleston, West Virginia, Estados Unidos, 25302
- West Virginia University Health Sciences Center - Charleston
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Wisconsin
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Green Bay, Wisconsin, Estados Unidos, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Marshfield, Wisconsin, Estados Unidos, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Midwest Children's Cancer Center
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Auckland, Nueva Zelanda, 1
- Starship Children's Health
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Christchurch, Nueva Zelanda
- Christchurch Hospital
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Bern, Suiza, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Suiza, 1205
- Swiss Pediatric Oncology Group Geneva
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
3 años a 24 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Histologically confirmed intracranial non-germinomatous germ cell tumor (NGGCT) of 1 of the following types:
- Endodermal sinus tumor (yolk sac tumor)
- Embryonal carcinoma
- Choriocarcinoma
- Immature teratoma and teratoma with malignant transformation
- Mixed germ cell tumor
- Histologically confirmed germinoma with elevation of serum/CSF beta human chorionic gonadotropin (HCG) levels greater than 50 mIU/mL or any serum/CSF alpha-fetoprotein (AFP) levels greater than 10 ng/ml or above institutional norm
- Histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF beta HCG levels greater than 50 mIU/mL or AFP levels greater than 10 ng/ml or above institutional norm
- Patients with normal AFP and beta HCG < 50 mIU/mL without histologic diagnosis of a NGGCT or patients with pure germinoma without elevation of tumor marker are ineligible
- Initial diagnosis within the past 31 days
PATIENT CHARACTERISTICS:
Age
- 3 to 24 at diagnosis
Performance status
- No minimum performance level
Life expectancy
- At least 8 weeks
Hematopoietic
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3 (transfusion independent)
- Hemoglobin at least 10.0 g/dL (transfusion allowed)
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT no greater than 2.5 times ULN
Renal
- Creatinine no greater than 1.5 times ULN OR
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Pulmonary
- No assisted ventilation
Other
- Seizure disorders allowed
- No patients in status or coma
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patient must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Prior corticosteroids allowed
- Concurrent corticosteroids allowed
- Concurrent endocrine replacement therapy allowed (e.g., L-thyroxine, testosterone, estrogen, desmopressin acetate)
- No concurrent growth hormone therapy
Radiotherapy
- Not specified
Surgery
- More than 1 prior surgery allowed
Other
- No other prior therapy for malignancy
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Radiation Therapy (CR from Induction)
Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6).
The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity.
Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours.
Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.
|
Dado IV
Otros nombres:
Dado IV
Otros nombres:
Dado IV
Otros nombres:
Dado IV
Otros nombres:
craniospinal irradiation
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Response to Induction Chemotherapy
Periodo de tiempo: 18 weeks
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A patient who achieves a complete or partial response, defined a reduction of at least 65% in tumor size after induction chemotherapy will be considered to have experienced response.
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18 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Probability of Event-free Survival (EFS)
Periodo de tiempo: At 3 years from study entry
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Event-free Survival was defined as time from study entry to death from any cause, disease progression or recurrence, or second malignant neoplasm.
Event-free survival was estimated by KM estimate.
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At 3 years from study entry
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Progression-free Survival (PFS)
Periodo de tiempo: At 3 years from study entry
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Progression-free Survival was defined as time from study entry to disease progression or recurrence.
Deaths that are clearly unrelated to disease progression, and second neoplasms are censored in this analysis.
Progression -free survival was estimated by KM estimate.
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At 3 years from study entry
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Overall Survival (OS)
Periodo de tiempo: At 3 years from study entry
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Overall Survival was defined as time from study entry to death from any cause.
Overall survival was estimated by KM estimate.
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At 3 years from study entry
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Number of Patients Experiencing Toxic Death
Periodo de tiempo: During chemotherapy (up to 18 weeks)
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Toxic death, defined as death predominantly attributable to treatment-related causes.
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During chemotherapy (up to 18 weeks)
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Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity
Periodo de tiempo: During chemotherapy(up to 18 weeks)
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The number of patients who experienced non-hematological grade 4 toxicities anytime during chemotherapy.
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During chemotherapy(up to 18 weeks)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Stewart Goldman, MD, Ann & Robert H Lurie Children's hospital of Chicago
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2004
Finalización primaria (Actual)
1 de febrero de 2009
Finalización del estudio (Actual)
1 de febrero de 2009
Fechas de registro del estudio
Enviado por primera vez
3 de octubre de 2002
Primero enviado que cumplió con los criterios de control de calidad
26 de enero de 2003
Publicado por primera vez (Estimar)
27 de enero de 2003
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de febrero de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
17 de enero de 2018
Última verificación
1 de enero de 2018
Más información
Términos relacionados con este estudio
Palabras clave
- tumor de células germinales del sistema nervioso central infantil
- teratoma infantil
- Tumor maligno de células germinativas infantil recidivante
- coriocarcinoma infantil del sistema nervioso central
- tumor embrionario del sistema nervioso central infantil
- germinoma del sistema nervioso central infantil
- tumor mixto de células germinativas del sistema nervioso central infantil
- teratoma del sistema nervioso central infantil
- tumor del saco vitelino del sistema nervioso central infantil
- tumor embrionario infantil recurrente del sistema nervioso central
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Neoplasias por tipo histológico
- Neoplasias por sitio
- Neoplasias
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias del Sistema Nervioso
- Neoplasias del Sistema Nervioso Central
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Carboplatino
- Etopósido
- Ifosfamida
- Mostaza isofosfamida
- Tiotepa
Otros números de identificación del estudio
- ACNS0122
- CDR0000257664 (Otro identificador: Clinical Trials.gov)
- COG-ACNS0122 (Otro identificador: Children's Oncology Group)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .