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Radiation Therapy in Treating Young Patients With Gliomas

24 luglio 2019 aggiornato da: Children's Oncology Group

A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas

RATIONALE: Specialized radiation therapy that delivers radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating young patients with gliomas.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

Primary

  • Determine the marginal-failure rate in young patients with low-grade gliomas treated with reduced-field conformal radiotherapy.

Secondary

  • Determine the progression-free survival, event-free survival, and overall survival rates of young patients treated with this regimen.
  • Determine quality of life of patients treated with this regimen.
  • Correlate MIB-1 labeling index with progression-free survival and overall survival of these patients.

OUTLINE: This is a multicenter study.

Patients undergo reduced-field conformal radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline or 6 weeks after completion of study treatment and then at 2 and 5 years (closed as of 10/27/2010).

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

92

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Children's Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Princess Margaret Hospital for Children
      • Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Quebec
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Children's & Women's Hospital of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J 3G9
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
      • London, Ontario, Canada, N6A 5W9
        • Children's Hospital of Western Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Hôpital Sainte Justine
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre at the University of Saskatchewan
      • Auckland, Nuova Zelanda, 1
        • Starship Children's Health
      • Christchurch, Nuova Zelanda, 8140
        • Christchurch Hospital
      • Wellington, Nuova Zelanda, 6002
        • Wellington Children's Hospital
      • Santurce, Porto Rico, 00912
        • San Jorge Children's Hospital
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35294
        • UAB Comprehensive Cancer Center
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85016-7710
        • Phoenix Children's Hospital
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Downey, California, Stati Uniti, 90027
        • Southern California Permanente Medical Group
      • Loma Linda, California, Stati Uniti, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Long Beach, California, Stati Uniti, 90801
        • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
      • Los Angeles, California, Stati Uniti, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Angeles, California, Stati Uniti, 90027
        • Childrens Hospital Los Angeles
      • Los Angeles, California, Stati Uniti, 90048-1865
        • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
      • Madera, California, Stati Uniti, 93638-8762
        • Children's Hospital Central California
      • Oakland, California, Stati Uniti, 94609
        • Children's Hospital and Research Center Oakland
      • Orange, California, Stati Uniti, 92868
        • Children's Hospital of Orange County
      • Sacramento, California, Stati Uniti, 95817
        • University of California Davis Cancer Center
      • Sacramento, California, Stati Uniti, 95825
        • Kaiser Permanente Medical Center - Oakland
      • San Diego, California, Stati Uniti, 92123-4282
        • Rady Children's Hospital - San Diego
      • San Francisco, California, Stati Uniti, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • Children's Hospital Center for Cancer and Blood Disorders
      • Denver, Colorado, Stati Uniti, 80218
        • Presbyterian - St. Luke's Medical Center
    • Connecticut
      • Hartford, Connecticut, Stati Uniti, 06106
        • Connecticut Children's Medical Center
    • Delaware
      • Wilmington, Delaware, Stati Uniti, 19803
        • Alfred I. DuPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
      • Washington, District of Columbia, Stati Uniti, 20307-5001
        • Walter Reed Army Medical Center
    • Florida
      • Fort Myers, Florida, Stati Uniti, 33901
        • Lee Cancer Care of Lee Memorial Health System
      • Hollywood, Florida, Stati Uniti, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Jacksonville, Florida, Stati Uniti, 32207
        • Nemours Children's Clinic
      • Miami, Florida, Stati Uniti, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami
      • Miami, Florida, Stati Uniti, 33155
        • Miami Children's Hospital
      • Orlando, Florida, Stati Uniti, 32803-1273
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
      • Orlando, Florida, Stati Uniti, 32806
        • Nemours Children's Clinic - Orlando
      • Orlando, Florida, Stati Uniti, 32806
        • M.D. Anderson Cancer Center at Orlando
      • Pensacola, Florida, Stati Uniti, 32504
        • Sacred Heart Cancer Center at Sacred Heart Hospital
      • Saint Petersburg, Florida, Stati Uniti, 33701
        • All Children's Hospital
      • Tampa, Florida, Stati Uniti, 33607
        • St. Joseph's Cancer Institute at St. Joseph's Hospital
      • West Palm Beach, Florida, Stati Uniti, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
      • Augusta, Georgia, Stati Uniti, 30912-3730
        • MBCCOP - Medical College of Georgia Cancer Center
    • Hawaii
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Cancer Research Center of Hawaii
    • Idaho
      • Boise, Idaho, Stati Uniti, 83712-6297
        • Mountain States Tumor Institute at St. Luke's Regional Medical Center
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Stati Uniti, 60612-7243
        • University of Illinois Cancer Center
      • Oak Lawn, Illinois, Stati Uniti, 60453
        • Keyser Family Cancer Center at Advocate Hope Children's Hospital
      • Park Ridge, Illinois, Stati Uniti, 60068-1174
        • Advocate Lutheran General Cancer Care Center
      • Peoria, Illinois, Stati Uniti, 61637
        • Saint Jude Midwest Affiliate
      • Springfield, Illinois, Stati Uniti, 62794-9677
        • Simmons Cooper Cancer Institute
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, Stati Uniti, 46260
        • St. Vincent Indianapolis Hospital
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
      • Louisville, Kentucky, Stati Uniti, 40232
        • Kosair Children's Hospital
    • Louisiana
      • Alexandria, Louisiana, Stati Uniti, 71315-3198
        • Tulane Cancer Center Office of Clinical Research
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Grand Rapids, Michigan, Stati Uniti, 49503-2560
        • Butterworth Hospital at Spectrum Health
      • Grosse Pointe Woods, Michigan, Stati Uniti, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Kalamazoo, Michigan, Stati Uniti, 49007-5381
        • CCOP - Kalamazoo
      • Lansing, Michigan, Stati Uniti, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55404
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, Stati Uniti, 39216-4505
        • University of Mississippi Cancer Clinic
    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64108
        • Children's Mercy Hospital
      • Saint Louis, Missouri, Stati Uniti, 63104
        • Cardinal Glennon Children's Hospital
      • Saint Louis, Missouri, Stati Uniti, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89109-2306
        • CCOP - Nevada Cancer Research Foundation
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, Stati Uniti, 07601
        • Hackensack University Medical Center Cancer Center
      • Morristown, New Jersey, Stati Uniti, 07962
        • Overlook Hospital
      • New Brunswick, New Jersey, Stati Uniti, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Paterson, New Jersey, Stati Uniti, 07503
        • St. Joseph's Hospital and Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87131-5636
        • University of New Mexico Cancer Center
    • New York
      • Bronx, New York, Stati Uniti, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Brooklyn, New York, Stati Uniti, 11219
        • Maimonides Cancer Center at Maimonides Medical Center
      • Buffalo, New York, Stati Uniti, 14263-0001
        • Roswell Park Cancer Institute
      • Mineola, New York, Stati Uniti, 11501
        • Winthrop University Hospital
      • New York, New York, Stati Uniti, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Stati Uniti, 10016
        • NYU Cancer Institute at New York University Medical Center
      • New York, New York, Stati Uniti, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
      • Rochester, New York, Stati Uniti, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Stony Brook, New York, Stati Uniti, 11794-9446
        • Stony Brook University Cancer Center
      • Syracuse, New York, Stati Uniti, 13210
        • SUNY Upstate Medical University Hospital
      • Valhalla, New York, Stati Uniti, 10595
        • New York Medical College
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, Stati Uniti, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem, North Carolina, Stati Uniti, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Akron, Ohio, Stati Uniti, 44308-1062
        • Akron Children's Hospital
      • Cincinnati, Ohio, Stati Uniti, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, Stati Uniti, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Stati Uniti, 44106-5000
        • Rainbow Babies and Children's Hospital
      • Columbus, Ohio, Stati Uniti, 43205-2696
        • Nationwide Children's Hospital
      • Dayton, Ohio, Stati Uniti, 45404-1815
        • Dayton Children's - Dayton
      • Toledo, Ohio, Stati Uniti, 43614
        • Medical University of Ohio Cancer Center
      • Youngstown, Ohio, Stati Uniti, 44501
        • Tod Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • Oklahoma University Cancer Institute
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239-3098
        • Knight Cancer Institute at Oregon Health and Science University
      • Portland, Oregon, Stati Uniti, 97227
        • Legacy Emanuel Hospital and Health Center and Children's Hospital
    • Pennsylvania
      • Hershey, Pennsylvania, Stati Uniti, 17033-0850
        • Penn State Children's Hospital
      • Philadelphia, Pennsylvania, Stati Uniti, 19134-1095
        • St. Christopher's Hospital for Children
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • Children's Hospital of Pittsburgh of UPMC
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Columbia, South Carolina, Stati Uniti, 29203
        • Palmetto Health South Carolina Cancer Center
      • Greenville, South Carolina, Stati Uniti, 29605
        • Greenville Hospital Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, Stati Uniti, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Tennessee
      • Knoxville, Tennessee, Stati Uniti, 37901
        • East Tennessee Children's Hospital
      • Memphis, Tennessee, Stati Uniti, 38105
        • St. Jude Children's Research Hospital
    • Texas
      • Amarillo, Texas, Stati Uniti, 79106
        • Texas Tech University Health Sciences Center School of Medicine - Amarillo
      • Corpus Christi, Texas, Stati Uniti, 78411
        • Driscoll Children's Hospital
      • Dallas, Texas, Stati Uniti, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Fort Worth, Texas, Stati Uniti, 76104
        • Cook Children's Medical Center - Fort Worth
      • Houston, Texas, Stati Uniti, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas
      • Lubbock, Texas, Stati Uniti, 79410
        • Covenant Children's Hospital
      • San Antonio, Texas, Stati Uniti, 78229-3993
        • Methodist Children's Hospital of South Texas
      • San Antonio, Texas, Stati Uniti, 78207
        • University of Texas Health Science Center at San Antonio
      • Temple, Texas, Stati Uniti, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84113-1100
        • Primary Children's Medical Center
    • Vermont
      • Burlington, Vermont, Stati Uniti, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Falls Church, Virginia, Stati Uniti, 22042-3300
        • INOVA Fairfax Hospital
      • Norfolk, Virginia, Stati Uniti, 23507-1971
        • Children's Hospital of The King's Daughters
      • Roanoke, Virginia, Stati Uniti, 24014
        • Carilion Medical Center for Children at Roanoke Community Hospital
    • Washington
      • Seattle, Washington, Stati Uniti, 98105
        • Children's Hospital and Regional Medical Center - Seattle
      • Spokane, Washington, Stati Uniti, 99220-2555
        • Providence Cancer Center at Sacred Heart Medical Center
    • West Virginia
      • Charleston, West Virginia, Stati Uniti, 25302
        • West Virginia University Health Sciences Center - Charleston
      • Huntington, West Virginia, Stati Uniti, 25701
        • Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
      • Morgantown, West Virginia, Stati Uniti, 26506
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Green Bay, Wisconsin, Stati Uniti, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Madison, Wisconsin, Stati Uniti, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Midwest Children's Cancer Center at Children's Hospital of Wisconsin
      • Geneva, Svizzera, 1205
        • Swiss Pediatric Oncology Group Geneva
      • Lausanne, Svizzera, 1011
        • Swiss Pediatric Oncology Group Lausanne

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 3 anni a 20 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

DISEASE CHARACTERISTICS:

  • Histologically confirmed* low-grade glioma, including any of the following:

    • Juvenile pilocytic astrocytoma (JPA) or pleomorphic JPA
    • Diffuse astrocytoma, including any of the following subtypes:

      • Fibrillary astrocytoma
      • Gemistocytic astrocytoma
      • Subependymal giant cell astrocytoma
      • Pleomorphic xanthoastrocytoma
    • Low-grade oligoastrocytoma
    • Low-grade oligodendroglioma
    • Low-grade glioma not otherwise specified NOTE: *Patients with chiasmatic lesions who have contiguous extension of tumor into other regions of the visual pathway by CT scan or MRI are eligible without histopathologic confirmation; repeat biopsy required for patients with recurrent tumors that enhance but whose initial tumor did not
  • Measurable disease by radiography
  • Meets any of the following criteria:

    • Progressive nonresectable disease

      • Any location in the brain
    • Patients with a less than gross total resection are eligible provided they are symptomatic from their tumor OR the risk from neurologic impairment with progression is high enough to warrant immediate treatment
    • Has undergone biopsy only
  • Must have received ≥ 1 course of prior chemotherapy (for patients < 10 years of age)

    • Prior chemotherapy optional (for patients ≥ 10 years of age)
  • No type-1 neurofibromatosis
  • No evidence of leptomeningeal dissemination

PATIENT CHARACTERISTICS:

Age

  • 3 to 20

Performance status

  • ECOG 0-2 OR
  • Karnofsky 50-100% (for patients > 16 years of age) OR
  • Lansky 50-100% (for patients ≤ 16 years of age)

Life expectancy

  • At least 1 year

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3 (transfusion independent)
  • Hemoglobin ≥ 10.0 g/dL (transfusions allowed)

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Not in status epilepticus, coma, or requiring assisted ventilation prior to study entry
  • Patients with a seizure disorder are eligible provided they are on anticonvulsants AND disease is well controlled

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • Concurrent dexamethasone allowed provided patient has been on a stable dose for ≥ 2 weeks prior to study entry
  • Concurrent dexamethasone allowed for symptoms of increased intracranial pressure

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • No other concurrent anticancer therapy

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Treatment (radiotherapy)
Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
Altri nomi:
  • Radioterapia conformazionale tridimensionale
  • 3D-CRT
  • IMRT
  • Radioterapia conformazionale 3D
  • radioterapia ad intensità modulata

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Marginal-failure Rate
Lasso di tempo: Up to 5 years
Patients who do not recur as well as those with either central or distant recurrence would be treatment successes for this endpoint. Monitoring will be based on a Bayesian rule, with binomial likelihood and a Beta on the parameter p, the proportion of failures that are marginal failures.
Up to 5 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free Survival Probability
Lasso di tempo: 3 years
To estimate the progression-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.
3 years
Event-free Survival Probability
Lasso di tempo: 3 years
To estimate the event-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation
3 years
Overall Survival Probability
Lasso di tempo: 3 years
To estimate the overall survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.
3 years
Quality of Life (QOL)
Lasso di tempo: Up to 5 years
QOL accessed using the Behavior Assessment System for Children (BASC), the Adaptive Behavior Assessment System (ABAS), the Behavior Rating Inventory of Executive Function (BRIEF), and the Symptom Checklist-90-R (SCL-90-R).
Up to 5 years
MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods
Lasso di tempo: At baseline
The MIB-1 labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive.
At baseline
Correlation MIB-1 Labeling Index With PFS
Lasso di tempo: Up to 10 years
The primary methods of analysis will be via stratified Cox regression
Up to 10 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: Edward G. Shaw, MD, Wake Forest University Health Sciences
  • Cattedra di studio: Joel M. Cherlow, MD, Todd Cancer Institute at Long Beach Memorial Medical Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2006

Completamento primario (Effettivo)

30 dicembre 2013

Completamento dello studio (Effettivo)

31 dicembre 2018

Date di iscrizione allo studio

Primo inviato

12 ottobre 2005

Primo inviato che soddisfa i criteri di controllo qualità

12 ottobre 2005

Primo Inserito (Stima)

13 ottobre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 luglio 2019

Ultimo verificato

1 novembre 2016

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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