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Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary

16. februar 2017 oppdatert av: Alliance for Clinical Trials in Oncology

A Phase II Study of Carboplatin (CBDCA), Paclitaxel (TAXOL), and Everolimus (RAD001) in Previously Untreated Patients With Measurable Disease With Cancer of Unknown Primary (CUP)

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well carboplatin given together with paclitaxel and everolimus works in treating patients with previously untreated cancer of unknown primary.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

Primary

  • Evaluate the response rate in patients with previously untreated cancer of unknown primary treated with the combination of carboplatin, paclitaxel, and everolimus.

Secondary

  • Assess time to progression, overall survival, duration of response, and time to treatment failure in patients treated with this regimen.
  • Determine adverse events of this regimen in these patients.
  • Perform descriptive correlative studies to determine response of specific tumor types, identified by the Origin-FFPE test, to this regimen.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive oral everolimus once daily on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients' tumor tissue samples from the most recent biopsy are analyzed for correlative studies, including gene expression profiling by Origin-FFPE test.

After completion of study therapy, patients are followed up every 3 months until disease progression, and then every 6 months for up to 3 years.

Studietype

Intervensjonell

Registrering (Faktiske)

46

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Colorado
      • Fort Collins, Colorado, Forente stater, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, Forente stater, 80528
        • Front Range Cancer Specialists
    • Connecticut
      • Hartford, Connecticut, Forente stater, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    • Illinois
      • Moline, Illinois, Forente stater, 61265
      • Moline, Illinois, Forente stater, 61265
        • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
    • Indiana
      • Elkhart, Indiana, Forente stater, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, Forente stater, 46514-2098
        • Elkhart Clinic, LLC
      • Elkhart, Indiana, Forente stater, 46514
        • Michiana Hematology-Oncology, PC - Elkhart
      • Indianapolis, Indiana, Forente stater, 46237
        • St. Francis Hospital Cancer Care Services
      • Kokomo, Indiana, Forente stater, 46904
        • Howard Community Hospital
      • La Porte, Indiana, Forente stater, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Mishawaka, Indiana, Forente stater, 46545-1470
        • Michiana Hematology-Oncology, PC - South Bend
      • Mishawaka, Indiana, Forente stater, 46545-1470
        • Saint Joseph Regional Medical Center
      • Plymouth, Indiana, Forente stater, 46563
        • Michiana Hematology Oncology PC - Plymouth
      • Richmond, Indiana, Forente stater, 47374
        • Reid Hospital & Health Care Services
      • South Bend, Indiana, Forente stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forente stater, 46601
        • CCOP - Northern Indiana CR Consortium
      • Westville, Indiana, Forente stater, 46391
        • Michiana Hematology Oncology PC - La Porte
    • Iowa
      • Ames, Iowa, Forente stater, 50010
        • McFarland Clinic, PC
      • Bettendorf, Iowa, Forente stater, 52722
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • Clive, Iowa, Forente stater, 50325
        • Medical Oncology and Hematology Associates - West Des Moines
      • Des Moines, Iowa, Forente stater, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, Forente stater, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, Forente stater, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, Forente stater, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, Forente stater, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Forente stater, 50316
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Ottumwa, Iowa, Forente stater, 52501
        • McCreery Cancer Center at Ottumwa Regional
      • Sioux City, Iowa, Forente stater, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, Forente stater, 51102
        • Mercy Medical Center - Sioux City
      • Sioux City, Iowa, Forente stater, 51104
        • St. Luke's Regional Medical Center
    • Kansas
      • Chanute, Kansas, Forente stater, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, Forente stater, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, Forente stater, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Fort Scott, Kansas, Forente stater, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Forente stater, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Forente stater, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence, Kansas, Forente stater, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, Forente stater, 67901
        • Cancer Center of Kansas, PA - Liberal
      • Newton, Kansas, Forente stater, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, Forente stater, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, Forente stater, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, Forente stater, 67401
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, Forente stater, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, Forente stater, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, Forente stater, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, Forente stater, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Forente stater, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, Forente stater, 67208
        • Associates in Womens Health, PA - North Review
      • Winfield, Kansas, Forente stater, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Michigan
      • Adrian, Michigan, Forente stater, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Ann Arbor, Michigan, Forente stater, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, Forente stater, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Battle Creek, Michigan, Forente stater, 49017
        • Battle Creek Health System Cancer Care Center
      • Dearborn, Michigan, Forente stater, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Escanaba, Michigan, Forente stater, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Flint, Michigan, Forente stater, 48503
        • Hurley Medical Center
      • Flint, Michigan, Forente stater, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, Forente stater, 49503
        • Butterworth Hospital at Spectrum Health
      • Grand Rapids, Michigan, Forente stater, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, Forente stater, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grosse Pointe Woods, Michigan, Forente stater, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Iron Mountain, Michigan, Forente stater, 49801
        • Dickinson County Healthcare System
      • Jackson, Michigan, Forente stater, 49201
        • Foote Memorial Hospital
      • Lansing, Michigan, Forente stater, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, Forente stater, 48154
        • St. Mary Mercy Hospital
      • Monroe, Michigan, Forente stater, 48162
        • Community Cancer Center of Monroe
      • Monroe, Michigan, Forente stater, 48162
        • Mercy Memorial Hospital - Monroe
      • Muskegon, Michigan, Forente stater, 49444
        • Mercy General Health Partners
      • Pontiac, Michigan, Forente stater, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, Forente stater, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Reed City, Michigan, Forente stater, 49677
        • Spectrum Health Reed City Hospital
      • Saginaw, Michigan, Forente stater, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Saint Joseph, Michigan, Forente stater, 49085
        • Lakeside Cancer Specialists, PLLC
      • Saint Joseph, Michigan, Forente stater, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
      • Traverse City, Michigan, Forente stater, 49684
        • Munson Medical Center
      • Warren, Michigan, Forente stater, 48093
        • St. John Macomb Hospital
    • Minnesota
      • Bemidji, Minnesota, Forente stater, 56601
        • MeritCare Bemidji
      • Duluth, Minnesota, Forente stater, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, Forente stater, 55805
        • Miller - Dwan Medical Center
      • Duluth, Minnesota, Forente stater, 55805-1983
        • Essentia Health - Duluth Clinic
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Springfield, Missouri, Forente stater, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Forente stater, 65807
        • Hulston Cancer Center at Cox Medical Center South
      • Springfield, Missouri, Forente stater, 65804
        • CCOP - Cancer Research for the Ozarks
    • Montana
      • Billings, Montana, Forente stater, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Forente stater, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, Forente stater, 59107-7000
        • Billings Clinic - Downtown
      • Billings, Montana, Forente stater, 59102
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Bozeman, Montana, Forente stater, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, Forente stater, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, Forente stater, 59405
        • Sletten Cancer Institute at Benefis Healthcare
      • Helena, Montana, Forente stater, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, Forente stater, 59901
        • Kalispell Regional Medical Center
      • Missoula, Montana, Forente stater, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, Forente stater, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • North Dakota
      • Bismarck, North Dakota, Forente stater, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, Forente stater, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, Forente stater, 58502
        • St. Alexius Medical Center Cancer Center
      • Fargo, North Dakota, Forente stater, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, Forente stater, 58102
        • MeritCare Broadway
    • Ohio
      • Bowling Green, Ohio, Forente stater, 43402
        • Wood County Oncology Center
      • Dayton, Ohio, Forente stater, 45405
        • Grandview Hospital
      • Dayton, Ohio, Forente stater, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, Forente stater, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, Forente stater, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, Forente stater, 45420
        • CCOP - Dayton
      • Elyria, Ohio, Forente stater, 44035
        • Community Cancer Center
      • Elyria, Ohio, Forente stater, 44035
        • Hematology Oncology Center
      • Findlay, Ohio, Forente stater, 45840
        • Blanchard Valley Medical Associates
      • Franklin, Ohio, Forente stater, 45005-1066
        • Middletown Regional Hospital
      • Greenville, Ohio, Forente stater, 45331
        • Wayne Hospital
      • Kettering, Ohio, Forente stater, 45429
        • Charles F. Kettering Memorial Hospital
      • Lima, Ohio, Forente stater, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, Forente stater, 43537-1839
        • Northwest Ohio Oncology Center
      • Oregon, Ohio, Forente stater, 43616
        • St. Charles Mercy Hospital
      • Oregon, Ohio, Forente stater, 43616
        • Toledo Clinic - Oregon
      • Sylvania, Ohio, Forente stater, 43560
        • Flower Hospital Cancer Center
      • Tiffin, Ohio, Forente stater, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, Forente stater, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, Forente stater, 43606
        • Toledo Hospital
      • Toledo, Ohio, Forente stater, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, Forente stater, 43617
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, Forente stater, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo, Ohio, Forente stater, 43623
        • St. Anne Mercy Hospital
      • Troy, Ohio, Forente stater, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wauseon, Ohio, Forente stater, 43567
        • Fulton County Health Center
      • Xenia, Ohio, Forente stater, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • South Dakota
      • Sioux Falls, South Dakota, Forente stater, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Virginia
      • Fredericksburg, Virginia, Forente stater, 22401
        • Fredericksburg Oncology, Incorporated
    • Wisconsin
      • Green Bay, Wisconsin, Forente stater, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Forente stater, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Forente stater, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, Forente stater, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Manitowoc, Wisconsin, Forente stater, 54221-1450
        • Holy Family Memorial Medical Center Cancer Care Center
      • Marinette, Wisconsin, Forente stater, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Oconto Falls, Wisconsin, Forente stater, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Sheboygan, Wisconsin, Forente stater, 53081
        • St. Nicholas Hospital
      • Sturgeon Bay, Wisconsin, Forente stater, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria

  • Histological confirmation of metastatic adenocarcinoma, poorly differentiated non-small cell carcinoma, or poorly differentiated squamous carcinoma
  • Adequate FFPE tissue or re-biopsy planned after registration but prior to treatment
  • Measurable disease as defined; for patients having only lesions measuring at least 1 cm to =< 2 cm must use spiral computed tomography (CT) imaging for both pre- and post-treatment tumor assessments; disease that has received prior radiation (performed for palliative reasons) cannot be used for measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Hemoglobin (Hgb) >= 9.0 g/dL
  • Absolute neutrophil count (ANC) >= 1,500/uL
  • Platelet count >= 100,000/uL
  • Total bilirubin =< upper limits of normal (ULN); if liver metastases are present, total bilirubin =< 2 x ULN
  • Aspartate aminotransferase (AST) =< 2.5 x ULN; if liver metastases are present, AST =< 5 x ULN
  • Creatinine =< 1.25 x ULN; if > 1.25 x ULN calculated creatinine clearance must be >= 60 ml/min
  • Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
  • Provide informed written consent
  • Willingness to return to NCCTG enrolling institution for follow-up
  • Willingness to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study

Exclusion Criteria

  • Any of the following:

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception; note: adequate contraception must be used throughout the trial and for 8 weeks after the last dose of RAD001, by both sexes
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

  • History of any of the following:

    • Known to be human immunodeficiency virus (HIV) positive
    • Known prior/current history of hepatitis related to hepatitis B or hepatitis C

  • Uncontrolled intercurrent illness including, but not limited to the following:

    • Ongoing or active infection (acute or chronic)
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Severely impaired lung function
    • Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN (note: optimal glycemic control should be achieved before starting trial therapy)
    • Liver disease such as cirrhosis or severe hepatic impairment
    • Psychiatric illness/social situations that would limit compliance with study requirements
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 4 weeks prior to registration
  • Other active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
  • Untreated brain metastases; NOTE: patients with treated, stable brain metastases for at least 12 weeks prior to study entry are eligible for enrollment
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
  • Active, bleeding diathesis
  • Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent; topical or inhaled corticosteroids are allowed
  • Currently on enzyme inducing anti-convulsants (EIACs) or other strong inducers or strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
  • Current use of warfarin (Coumadin); EXCEPTION: current use of low-molecular weight heparin is allowed
  • Known to be HIV positive
  • Inoculated with live attenuated vaccines =< 2 weeks prior to registration; note: close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus; examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guerin (BCG), yellow fever, varicella and TY21a typhoid vaccines
  • =< 4 weeks from major surgery; note: for this study, diagnostic laparoscopy (without other intervention) and/or biopsies (needle aspirate, core biopsy, open biopsy, etc.) are not considered major surgery

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treatment (carboplatin, paclitaxel, and everolimus)
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Legemiddel: paklitaksel
Gitt IV
Legemiddel: karboplatin
Gitt IV
Legemiddel: everolimus
Gitt PO

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Confirmed Tumor Responses
Tidsramme: First 6 Cycles of treatment (an average of 6 months)

Confirmed tumor response was defined to be either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:

  • Complete Response (CR): disappearance of all target lesions;
  • Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
First 6 Cycles of treatment (an average of 6 months)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival
Tidsramme: Time from registration to death or last follow-up (up to 3 years)
Overall survival was defined as the time from study enrollment to the time of death from any cause or last follow-up.
Time from registration to death or last follow-up (up to 3 years)
Progression-free Survival
Tidsramme: Time from registration to the disease progression or death (up to 3 years)
The progression-free survival (PFS) was defined as the time from date of registration to the documentation of disease progression or death as a result of any cause, whichever comes first.
Time from registration to the disease progression or death (up to 3 years)
Duration of Response
Tidsramme: Up to 3 years
Duration of response was defined for all evaluable participants who have achieved an objective response as the date at which the participant's objective status is first noted to be either CR or PR to the date progression is documented.
Up to 3 years
Time to Treatment Failure
Tidsramme: Up to 3 years
Time to treatment failure was defined to be the time from the date of registration to the date at which the participant is removed from treatment due to progression, adverse events, or refusal.
Up to 3 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Matthew P. Goetz, MD, Mayo Clinic

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2009

Primær fullføring (Faktiske)

1. desember 2012

Studiet fullført (Faktiske)

1. august 2013

Datoer for studieregistrering

Først innsendt

8. juli 2009

Først innsendt som oppfylte QC-kriteriene

8. juli 2009

Først lagt ut (Anslag)

10. juli 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. mars 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. februar 2017

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NCCTG-N0871
  • NCI-2011-01926 (Registeridentifikator: CTRP (Clinical Trials Reporting System))
  • CDR0000643361 (Registeridentifikator: PDQ (Physician Data Query))

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere