Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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 stycznia 2018 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

104

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Children's Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Royal Children's Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Princess Margaret Hospital for Children
      • Quebec, Kanada, G1V 4G2
        • Centre Hospitalier Universitaire de Quebec
    • British Columbia
      • Vancouver, British Columbia, Kanada, V6H 3V4
        • Children's & Women's Hospital of British Columbia
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
        • Janeway Children's Health and Rehabilitation Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada, B3K 6R8
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Kanada, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
      • Toronto, Ontario, Kanada, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Kanada, H3H 1P3
        • Montreal Children's Hospital at McGill University Health Center
      • Montreal, Quebec, Kanada, H3T 1C5
        • Hôpital Sainte Justine
    • Saskatchewan
      • Saskatoon, Saskatchewan, Kanada, S7N 4H4
        • Saskatoon Cancer Centre at the University of Saskatchewan
      • Auckland, Nowa Zelandia, 1
        • Starship Children's Health
      • Christchurch, Nowa Zelandia
        • Christchurch Hospital
    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone, 35294
        • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
    • Arizona
      • Phoenix, Arizona, Stany Zjednoczone, 85016-7710
        • Phoenix Children's Hospital
    • Arkansas
      • Little Rock, Arkansas, Stany Zjednoczone, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Downey, California, Stany Zjednoczone, 90242-2814
        • Southern California Permanente Medical Group
      • Loma Linda, California, Stany Zjednoczone, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Long Beach, California, Stany Zjednoczone, 90801
        • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
      • Los Angeles, California, Stany Zjednoczone, 90027
        • Childrens Hospital Los Angeles
      • Madera, California, Stany Zjednoczone, 93638-8762
        • Children's Hospital Central California
      • Oakland, California, Stany Zjednoczone, 94609
        • Children's Hospital and Research Center Oakland
      • Orange, California, Stany Zjednoczone, 92868
        • Children's Hospital of Orange County
      • Sacramento, California, Stany Zjednoczone, 95816
        • Sutter Cancer Center
      • San Diego, California, Stany Zjednoczone, 92123-4282
        • Rady Children's Hospital - San Diego
      • San Francisco, California, Stany Zjednoczone, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
      • Stanford, California, Stany Zjednoczone, 94305-5824
        • Stanford Cancer Center
    • Connecticut
      • Farmington, Connecticut, Stany Zjednoczone, 06360-2875
        • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
    • Delaware
      • Wilmington, Delaware, Stany Zjednoczone, 19803
        • Alfred I. DuPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, Stany Zjednoczone, 20010-2970
        • Children's National Medical Center
    • Florida
      • Fort Myers, Florida, Stany Zjednoczone, 33901
        • Lee Cancer Care of Lee Memorial Health System
      • Gainesville, Florida, Stany Zjednoczone, 32610-0232
        • University of Florida Shands Cancer Center
      • Jacksonville, Florida, Stany Zjednoczone, 32207
        • Nemours Children's Clinic
      • Miami, Florida, Stany Zjednoczone, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami
      • Miami, Florida, Stany Zjednoczone, 33155
        • Miami Children's Hospital
      • Orlando, Florida, Stany Zjednoczone, 32803-1273
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
      • Pensacola, Florida, Stany Zjednoczone, 32504
        • Sacred Heart Cancer Center at Sacred Heart Hospital
      • Saint Petersburg, Florida, Stany Zjednoczone, 33701
        • All Children's Hospital
      • Tampa, Florida, Stany Zjednoczone, 33607
        • St. Joseph's Cancer Institute at St. Joseph's Hospital
      • West Palm Beach, Florida, Stany Zjednoczone, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30322
        • Winship Cancer Institute of Emory University
      • Augusta, Georgia, Stany Zjednoczone, 30912-3730
        • MBCCOP - Medical College of Georgia Cancer Center
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Chicago, Illinois, Stany Zjednoczone, 60637-1470
        • University of Chicago Cancer Research Center
      • Park Ridge, Illinois, Stany Zjednoczone, 60068-1174
        • Advocate Lutheran General Cancer Care Center
      • Springfield, Illinois, Stany Zjednoczone, 62794-9677
        • Simmons Cooper Cancer Institute
    • Indiana
      • Indianapolis, Indiana, Stany Zjednoczone, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, Stany Zjednoczone, 46260
        • St. Vincent Indianapolis Hospital
    • Kansas
      • Kansas City, Kansas, Stany Zjednoczone, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Boston, Massachusetts, Stany Zjednoczone, 02111
        • Floating Hospital for Children at Tufts - New England Medical Center
    • Michigan
      • Detroit, Michigan, Stany Zjednoczone, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Grand Rapids, Michigan, Stany Zjednoczone, 49503-2560
        • Butterworth Hospital at Spectrum Health
      • Grosse Pointe Woods, Michigan, Stany Zjednoczone, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Lansing, Michigan, Stany Zjednoczone, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Stany Zjednoczone, 55404
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
      • Minneapolis, Minnesota, Stany Zjednoczone, 55455
        • Masonic Cancer Center at University of Minnesota
      • Rochester, Minnesota, Stany Zjednoczone, 55905
        • Mayo Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, Stany Zjednoczone, 39216-4505
        • University of Mississippi Cancer Clinic
    • Missouri
      • Kansas City, Missouri, Stany Zjednoczone, 64108
        • Children's Mercy Hospital
      • Saint Louis, Missouri, Stany Zjednoczone, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    • New Jersey
      • Hackensack, New Jersey, Stany Zjednoczone, 07601
        • Hackensack University Medical Center Cancer Center
      • New Brunswick, New Jersey, Stany Zjednoczone, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Newark, New Jersey, Stany Zjednoczone, 07112
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, Stany Zjednoczone, 07503
        • St. Joseph's Hospital and Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Stany Zjednoczone, 87131-5636
        • University of New Mexico Cancer Center
    • New York
      • Bronx, New York, Stany Zjednoczone, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • New York, New York, Stany Zjednoczone, 10016
        • NYU Cancer Institute at New York University Medical Center
      • New York, New York, Stany Zjednoczone, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
      • Syracuse, New York, Stany Zjednoczone, 13210
        • SUNY Upstate Medical University Hospital
      • Valhalla, New York, Stany Zjednoczone, 10595
        • New York Medical College
    • North Carolina
      • Charlotte, North Carolina, Stany Zjednoczone, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Durham, North Carolina, Stany Zjednoczone, 27710
        • Duke Comprehensive Cancer Center
    • Ohio
      • Akron, Ohio, Stany Zjednoczone, 44308-1062
        • Akron Children's Hospital
      • Cincinnati, Ohio, Stany Zjednoczone, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, Stany Zjednoczone, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, Stany Zjednoczone, 43205-2696
        • Nationwide Children's Hospital
      • Dayton, Ohio, Stany Zjednoczone, 45404-1815
        • Children's Medical Center - Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
        • Oklahoma University Cancer Institute
    • Oregon
      • Portland, Oregon, Stany Zjednoczone, 97239-3098
        • Oregon Health and Science University Cancer Institute
    • Pennsylvania
      • Hershey, Pennsylvania, Stany Zjednoczone, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19134-1095
        • St. Christopher's Hospital for Children
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19104-9786
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
        • Children's Hospital of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, Stany Zjednoczone, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • South Carolina
      • Charleston, South Carolina, Stany Zjednoczone, 29425
        • Hollings Cancer Center at Medical University of South Carolina
    • South Dakota
      • Sioux Falls, South Dakota, Stany Zjednoczone, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Tennessee
      • Memphis, Tennessee, Stany Zjednoczone, 38105
        • St. Jude Children's Research Hospital
      • Nashville, Tennessee, Stany Zjednoczone, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Austin, Texas, Stany Zjednoczone, 78723
        • Dell Children's Medical Center of Central Texas
      • Corpus Christi, Texas, Stany Zjednoczone, 78411
        • Driscoll Children's Hospital
      • Dallas, Texas, Stany Zjednoczone, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Fort Worth, Texas, Stany Zjednoczone, 76104
        • Cook Children's Medical Center - Fort Worth
      • Lubbock, Texas, Stany Zjednoczone, 79410
        • Covenant Children's Hospital
      • San Antonio, Texas, Stany Zjednoczone, 78229-3993
        • Methodist Children's Hospital of South Texas
      • San Antonio, Texas, Stany Zjednoczone, 78207
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Salt Lake City, Utah, Stany Zjednoczone, 84113-1100
        • Primary Children's Medical Center
    • Virginia
      • Norfolk, Virginia, Stany Zjednoczone, 23507-1971
        • Children's Hospital of The King's Daughters
    • West Virginia
      • Charleston, West Virginia, Stany Zjednoczone, 25302
        • West Virginia University Health Sciences Center - Charleston
    • Wisconsin
      • Green Bay, Wisconsin, Stany Zjednoczone, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Marshfield, Wisconsin, Stany Zjednoczone, 54449
        • Marshfield Clinic - Marshfield Center
      • Milwaukee, Wisconsin, Stany Zjednoczone, 53226
        • Midwest Children's Cancer Center
      • Bern, Szwajcaria, 3010
        • Swiss Pediatric Oncology Group Bern
      • Geneva, Szwajcaria, 1205
        • Swiss Pediatric Oncology Group Geneva

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

3 lata do 24 lata (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Biorąc pod uwagę IV
Inne nazwy:
  • VP-16
  • Etopofos
  • VePesid
  • NSC nr 141540
Biorąc pod uwagę IV
Inne nazwy:
  • Paraplatyna
  • NSC nr 241240
Biorąc pod uwagę IV
Inne nazwy:
  • Tiofosfamid
  • Tespa
  • Trietylenotiofosforamid Tspa
  • WR-45312
  • NSC nr 6396
Biorąc pod uwagę IV
Inne nazwy:
  • Ifex
  • Ifosfamid
  • Izofosfamid
  • Z4942
  • NSC nr 109724
craniospinal irradiation
Inne nazwy:
  • Craniospinal irradiation (CSI) followed by boost radiation to the sites of gross disease at diagnosis.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Response to Induction Chemotherapy
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
The Probability of Event-free Survival (EFS)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Krzesło do nauki: Stewart Goldman, MD, Ann & Robert H Lurie Children's hospital of Chicago

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 stycznia 2004

Zakończenie podstawowe (Rzeczywisty)

1 lutego 2009

Ukończenie studiów (Rzeczywisty)

1 lutego 2009

Daty rejestracji na studia

Pierwszy przesłany

3 października 2002

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 stycznia 2003

Pierwszy wysłany (Oszacować)

27 stycznia 2003

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 lutego 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 stycznia 2018

Ostatnia weryfikacja

1 stycznia 2018

Więcej informacji

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj