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 januari 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
104
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Queensland
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Brisbane, Queensland, Australien, 4029
- Royal Children's Hospital
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Victoria
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Parkville, Victoria, Australien, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australien, 6001
- Princess Margaret Hospital for Children
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Phoenix, Arizona, Förenta staterna, 85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Förenta staterna, 90242-2814
- Southern California Permanente Medical Group
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Loma Linda, California, Förenta staterna, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Förenta staterna, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Förenta staterna, 90027
- Childrens Hospital Los Angeles
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Madera, California, Förenta staterna, 93638-8762
- Children's Hospital Central California
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Oakland, California, Förenta staterna, 94609
- Children's Hospital and Research Center Oakland
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Orange, California, Förenta staterna, 92868
- Children's Hospital of Orange County
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Sacramento, California, Förenta staterna, 95816
- Sutter Cancer Center
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San Diego, California, Förenta staterna, 92123-4282
- Rady Children's Hospital - San Diego
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San Francisco, California, Förenta staterna, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Stanford, California, Förenta staterna, 94305-5824
- Stanford Cancer Center
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Connecticut
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Farmington, Connecticut, Förenta staterna, 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, Förenta staterna, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20010-2970
- Children's National Medical Center
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Florida
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Fort Myers, Florida, Förenta staterna, 33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville, Florida, Förenta staterna, 32610-0232
- University of Florida Shands Cancer Center
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Jacksonville, Florida, Förenta staterna, 32207
- Nemours Children's Clinic
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Miami, Florida, Förenta staterna, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Förenta staterna, 33155
- Miami Children's Hospital
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Orlando, Florida, Förenta staterna, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Pensacola, Florida, Förenta staterna, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg, Florida, Förenta staterna, 33701
- All Children's Hospital
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Tampa, Florida, Förenta staterna, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Förenta staterna, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Winship Cancer Institute of Emory University
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Augusta, Georgia, Förenta staterna, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Illinois
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Chicago, Illinois, Förenta staterna, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago, Illinois, Förenta staterna, 60637-1470
- University of Chicago Cancer Research Center
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Park Ridge, Illinois, Förenta staterna, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Springfield, Illinois, Förenta staterna, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Förenta staterna, 46260
- St. Vincent Indianapolis Hospital
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Kansas
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Kansas City, Kansas, Förenta staterna, 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, Förenta staterna, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Förenta staterna, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Michigan
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Detroit, Michigan, Förenta staterna, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids, Michigan, Förenta staterna, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Förenta staterna, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Lansing, Michigan, Förenta staterna, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, Förenta staterna, 55455
- Masonic Cancer Center at University of Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Förenta staterna, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Kansas City, Missouri, Förenta staterna, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Förenta staterna, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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New Jersey
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Hackensack, New Jersey, Förenta staterna, 07601
- Hackensack University Medical Center Cancer Center
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New Brunswick, New Jersey, Förenta staterna, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Förenta staterna, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Förenta staterna, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Förenta staterna, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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New York, New York, Förenta staterna, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, Förenta staterna, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Syracuse, New York, Förenta staterna, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Förenta staterna, 10595
- New York Medical College
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Durham, North Carolina, Förenta staterna, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Akron, Ohio, Förenta staterna, 44308-1062
- Akron Children's Hospital
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Cincinnati, Ohio, Förenta staterna, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Förenta staterna, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Förenta staterna, 45404-1815
- Children's Medical Center - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Förenta staterna, 97239-3098
- Oregon Health and Science University Cancer Institute
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Pennsylvania
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Hershey, Pennsylvania, Förenta staterna, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Förenta staterna, 19134-1095
- St. Christopher's Hospital for Children
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Philadelphia, Pennsylvania, Förenta staterna, 19104-9786
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Förenta staterna, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29425
- Hollings Cancer Center at Medical University of South Carolina
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South Dakota
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Sioux Falls, South Dakota, Förenta staterna, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38105
- St. Jude Children's Research Hospital
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Nashville, Tennessee, Förenta staterna, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Austin, Texas, Förenta staterna, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, Förenta staterna, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Förenta staterna, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Förenta staterna, 76104
- Cook Children's Medical Center - Fort Worth
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Lubbock, Texas, Förenta staterna, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Förenta staterna, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Förenta staterna, 78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Förenta staterna, 84113-1100
- Primary Children's Medical Center
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Virginia
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Norfolk, Virginia, Förenta staterna, 23507-1971
- Children's Hospital of The King's Daughters
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West Virginia
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Charleston, West Virginia, Förenta staterna, 25302
- West Virginia University Health Sciences Center - Charleston
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Wisconsin
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Green Bay, Wisconsin, Förenta staterna, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Midwest Children's Cancer Center
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Quebec, Kanada, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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British Columbia
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Vancouver, British Columbia, Kanada, 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, Kanada, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Kanada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Toronto, Ontario, Kanada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Kanada, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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Montreal, Quebec, Kanada, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Auckland, Nya Zeeland, 1
- Starship Children's Health
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Christchurch, Nya Zeeland
- Christchurch Hospital
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Bern, Schweiz, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Schweiz, 1205
- Swiss Pediatric Oncology Group Geneva
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
3 år till 24 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Givet IV
Andra namn:
Givet IV
Andra namn:
Givet IV
Andra namn:
Givet IV
Andra namn:
craniospinal irradiation
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Response to Induction Chemotherapy
Tidsram: 18 weeks
|
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.
|
18 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The Probability of Event-free Survival (EFS)
Tidsram: At 3 years from study entry
|
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.
|
At 3 years from study entry
|
|
Progression-free Survival (PFS)
Tidsram: At 3 years from study entry
|
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.
|
At 3 years from study entry
|
|
Overall Survival (OS)
Tidsram: At 3 years from study entry
|
Overall Survival was defined as time from study entry to death from any cause.
Overall survival was estimated by KM estimate.
|
At 3 years from study entry
|
|
Number of Patients Experiencing Toxic Death
Tidsram: During chemotherapy (up to 18 weeks)
|
Toxic death, defined as death predominantly attributable to treatment-related causes.
|
During chemotherapy (up to 18 weeks)
|
|
Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity
Tidsram: During chemotherapy(up to 18 weeks)
|
The number of patients who experienced non-hematological grade 4 toxicities anytime during chemotherapy.
|
During chemotherapy(up to 18 weeks)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studiestol: Stewart Goldman, MD, Ann & Robert H Lurie Children's hospital of Chicago
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2004
Primärt slutförande (Faktisk)
1 februari 2009
Avslutad studie (Faktisk)
1 februari 2009
Studieregistreringsdatum
Först inskickad
3 oktober 2002
Först inskickad som uppfyllde QC-kriterierna
26 januari 2003
Första postat (Uppskatta)
27 januari 2003
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 februari 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 januari 2018
Senast verifierad
1 januari 2018
Mer information
Termer relaterade till denna studie
Nyckelord
- barndomens centrala nervsystemets könscellstumör
- barndomens teratom
- återkommande barndomsmaligna könscellstumörer
- barndomens koriokarcinom i centrala nervsystemet
- embryonal tumör i centrala nervsystemet hos barn
- barndoms germinom i centrala nervsystemet
- barndomens centrala nervsystem blandad könscellstumör
- barndoms teratom i centrala nervsystemet
- barndomens centrala nervsystemet gulesäckstumör
- återkommande embryonal tumör i centrala nervsystemet hos barn
Ytterligare relevanta MeSH-villkor
- Sjukdomar i nervsystemet
- Neoplasmer efter histologisk typ
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer, könsceller och embryonala
- Neoplasmer i nervsystemet
- Neoplasmer i centrala nervsystemet
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Myeloablativa agonister
- Antineoplastiska medel, fytogena
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Karboplatin
- Etoposid
- Ifosfamid
- Isofosfamidsenap
- Thiotepa
Andra studie-ID-nummer
- ACNS0122
- CDR0000257664 (Annan identifierare: Clinical Trials.gov)
- COG-ACNS0122 (Annan identifierare: Children's Oncology Group)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .