- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00005836
Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- Based Chemotherapy
Phase II Evaluation of Oxaliplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have recurrent or refractory ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based chemotherapy.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES: I. Determine the antitumor activity of oxaliplatin by measuring response rate in patients with recurrent or refractory, platinum resistant ovarian epithelial or primary peritoneal carcinoma who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of this drug in this patient population.
OUTLINE: Patients receive oxaliplatin IV over 2 hours. Treatment continues every 21 days for a maximum of 9 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 12-14 months.
Undersøgelsestype
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Ontario
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Kingston, Ontario, Canada, K7L 3N6
- NCIC-Clinical Trials Group
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Forenede Stater, 85006-2726
- CCOP - Greater Phoenix
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California
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Los Angeles, California, Forenede Stater, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Orange, California, Forenede Stater, 92868
- Chao Family Comprehensive Cancer Center
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Palo Alto, California, Forenede Stater, 94304
- Women's Cancer Center
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Colorado
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Denver, Colorado, Forenede Stater, 80262
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, Forenede Stater, 20007
- Vincent T. Lombardi Cancer Research Center, Georgetown University
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Florida
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Tampa, Florida, Forenede Stater, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Emory University Hospital - Atlanta
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- MBCCOP - Hawaii
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Illinois
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Chicago, Illinois, Forenede Stater, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Forenede Stater, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago Cancer Research Center
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Evanston, Illinois, Forenede Stater, 60201
- CCOP - Evanston
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Springfield, Illinois, Forenede Stater, 62526
- CCOP - Central Illinois
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202-5265
- Indiana University Cancer Center
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Iowa
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Des Moines, Iowa, Forenede Stater, 10309-1016
- CCOP - Iowa Oncology Research Association
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins Oncology Center
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Bethesda, Maryland, Forenede Stater, 20892
- Radiation Oncology Branch
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Bethesda, Maryland, Forenede Stater, 20892
- Medicine Branch
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
- Tufts University School of Medicine
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Worcester, Massachusetts, Forenede Stater, 01655
- University of Massachusetts Memorial Medical Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Forenede Stater, 48201
- Barbara Ann Karmanos Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota Cancer Center
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216-4505
- University of Mississippi Medical Center
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Keesler AFB, Mississippi, Forenede Stater, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Columbia, Missouri, Forenede Stater, 65203
- Ellis Fischel Cancer Center
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
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Springfield, Missouri, Forenede Stater, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68131
- CCOP - Missouri Valley Cancer Consortium
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Jersey
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Camden, New Jersey, Forenede Stater, 08103
- Cooper Hospital/University Medical Center
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New York
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Albany, New York, Forenede Stater, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, Forenede Stater, 11203
- State University of New York Health Science Center at Brooklyn
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Manhasset, New York, Forenede Stater, 11030
- North Shore University Hospital
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New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Cancer Center
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Stony Brook, New York, Forenede Stater, 11790-9832
- State University of New York Health Sciences Center - Stony Brook
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, Forenede Stater, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Forenede Stater, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Brookview Research, Inc.
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45219
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Cancer Center
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Cleveland, Ohio, Forenede Stater, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, Forenede Stater, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73190
- University of Oklahoma College of Medicine
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Tulsa, Oklahoma, Forenede Stater, 74136
- CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
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Oregon
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Portland, Oregon, Forenede Stater, 97213
- CCOP - Columbia River Program
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Pennsylvania
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Abington, Pennsylvania, Forenede Stater, 19001
- Abington Memorial Hospital
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Hershey, Pennsylvania, Forenede Stater, 17033
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Forenede Stater, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Pennsylvania Hospital
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Wynnewood, Pennsylvania, Forenede Stater, 19096
- CCOP - MainLine Health
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425-0721
- Medical University of South Carolina
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Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38117
- CCOP - Baptist Cancer Institute
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Texas
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Dallas, Texas, Forenede Stater, 75235-9154
- Simmons Cancer Center - Dallas
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Houston, Texas, Forenede Stater, 77030
- University of Texas - MD Anderson Cancer Center
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Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- Cancer Center, University of Virginia HSC
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Washington
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Seattle, Washington, Forenede Stater, 98195-6043
- University of Washington Medical Center
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Tacoma, Washington, Forenede Stater, 98405
- Tacoma General Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory ovarian epithelial or primary peritoneal carcinoma Bidimensionally measurable disease Ascites and pleural effusions are not considered measurable disease Sonography acceptable provided lesions are clearly defined on initial examination and bidimensionally measurable Must have had 1 prior platinum based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease Initial treatment may include high dose therapy, consolidation, or extended therapy administered after surgical or nonsurgical assessment No additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens Must be considered platinum resistant or refractory Treatment free interval of less than 6 months following platinum or progression during platinum based therapy No known brain metastases Must not be eligible for a higher priority GOG protocol
PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least lower limit of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection requiring antibiotics No evidence of preexisting peripheral sensory neuropathy greater than grade 1, including residual neuropathy attributed to prior chemotherapy and other chronic conditions (e.g., diabetes, venous stasis, and carpal tunnel syndrome) No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy No other uncontrolled concurrent illness (e.g., ongoing or active infection) No other malignancy within the past 5 years except nonmelanoma skin cancer and no other prior malignancy whose prior cancer treatment contraindicates this protocol therapy
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy At least 3 weeks since prior immunotherapy No concurrent colony stimulating factors (CSFs) during first course of therapy At least 24 hours since prior CSFs during subsequent courses of therapy Chemotherapy: See Disease Characteristics No prior oxaliplatin No more than 1 prior chemotherapy regimen If initial therapy did not include paclitaxel, a second regimen including paclitaxel is allowed At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: At least 1 week since prior hormonal therapy directed at malignant tumor Concurrent continuation of hormone replacement therapy allowed Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to sites of measurable disease used on this trial No prior radiotherapy to greater than 25% of bone marrow Surgery: At least 3 weeks since prior surgery and recovered Other: No other concurrent investigational agents No concurrent antiretroviral therapy (HAART)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Paula M. Fracasso, MD, PhD, Washington University Siteman Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Genitale neoplasmer, kvindelige
- Sygdomme i det endokrine system
- Ovariesygdomme
- Adnexale sygdomme
- Gonadale lidelser
- Neoplasmer i endokrine kirtler
- Ovariale neoplasmer
- Karcinom, ovarieepitel
- Antineoplastiske midler
- Oxaliplatin
Andre undersøgelses-id-numre
- CDR0000067851
- GOG-126K
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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-
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