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Gefitinib With or Without Carboplatin and Paclitaxel in Treating Older Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer

12. december 2016 opdateret af: Alliance for Clinical Trials in Oncology

Parallel Phase II Trials of ZD1839 (Iressa) Alone or Weekly Carboplatin and Paclitaxel Followed by ZD1839 (Iressa) (Oncologists Must Choose) for Metastatic Non-Small Cell Lung Cancer in Patients > or = 65 Years of Age

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with carboplatin and paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gefitinib alone or together with carboplatin and paclitaxel works in treating older patients with unresectable or metastatic non-small cell lung cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the 6-month progression status of older patients with unresectable or metastatic non-small cell lung cancer treated with gefitinib alone or with carboplatin and paclitaxel.

Secondary

  • Determine the response rate in patients treated with these regimens.
  • Determine the quality of life of patients treated with these regimens.
  • Determine whether serum-secreted or soluble epidermal growth factor receptor (EGFR) concentrations predict response in patients treated with these regimens.
  • Correlate the presence of social support for these patients with toxicity and efficacy of these regimens.
  • Determine whether social support for these patients differs according to gender.
  • Determine the reasons an oncologist would choose a chemotherapy vs a nonchemotherapy regimen for these patients.

Tertiary

  • Correlate EGFR signaling pathway markers, RNA expression profile, gene polymorphisms of prespecified germline and tumor genes, and plasma and urine proteomic patterns with response rate and time to progression of patients receiving treatment in group I.

OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment groups as determined by their treating physician.

  • Group I: Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Group II: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of chemotherapy and in the absence of disease progression, patients receive oral gefitinib as in group I.

Quality of life is assessed at baseline and after the completion of course 2.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 107 patients (51 for group I and 56 for group II) will be accrued for this study within 1.7 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

65

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
  • Forenede Stater
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Mayo Clinic Scottsdale
    • Colorado
      • Fort Collins, Colorado, Forenede Stater, 80524
        • Front Range Cancer Specialists
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • Mayo Clinic - Jacksonville
    • Illinois
      • Aurora, Illinois, Forenede Stater, 60507
        • Rush-Copley Cancer Care Center
      • Bloomington, Illinois, Forenede Stater, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, Forenede Stater, 61520
        • Graham Hospital
      • Carthage, Illinois, Forenede Stater, 62321
        • Memorial Hospital
      • Effingham, Illinois, Forenede Stater, 62401
        • St. Anthony's Memorial Hospital
      • Eureka, Illinois, Forenede Stater, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Galesburg Clinic
      • Havana, Illinois, Forenede Stater, 62644
        • Mason District Hospital
      • Hopedale, Illinois, Forenede Stater, 61747
        • Hopedale Medical Complex
      • Joliet, Illinois, Forenede Stater, 60435
        • Joliet Oncology Hematology Associates, Limited - West
      • Kewanee, Illinois, Forenede Stater, 61443
        • Kewanee Hospital
      • Macomb, Illinois, Forenede Stater, 61455
        • Mcdonough District Hospital
      • Normal, Illinois, Forenede Stater, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, Forenede Stater, 61761
        • Community Cancer Center
      • Ottawa, Illinois, Forenede Stater, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, Forenede Stater, 61350
        • Oncology Hematology Associates of Central Illinois - Ottawa
      • Pekin, Illinois, Forenede Stater, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, Forenede Stater, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Forenede Stater, 61614
        • Proctor Hospital
      • Peoria, Illinois, Forenede Stater, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, Forenede Stater, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, Forenede Stater, 61615
        • Oncology/Hematology Associates of Central Illinois, P.C.
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, Forenede Stater, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, Forenede Stater, 61362
        • St. Margaret's Hospital
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, Forenede Stater, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Beech Grove, Indiana, Forenede Stater, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Michigan City, Indiana, Forenede Stater, 46360
        • Saint Anthony Memorial Health Centers
    • Iowa
      • Cedar Rapids, Iowa, Forenede Stater, 52402
        • St. Luke's Hospital
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • Des Moines, Iowa, Forenede Stater, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, Forenede Stater, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, Forenede Stater, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, Forenede Stater, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, Forenede Stater, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Forenede Stater, 50307
        • Mercy Capitol Hospital
      • Des Moines, Iowa, Forenede Stater, 50316-2301
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Sioux City, Iowa, Forenede Stater, 51101
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, Forenede Stater, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, Forenede Stater, 51104
        • Mercy Medical Center - Sioux City
      • Sioux City, Iowa, Forenede Stater, 51101
        • Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
      • West Des Moines, Iowa, Forenede Stater, 50266
        • Medical Oncology and Hematology Associates - West Des Moines
    • Kansas
      • Chanute, Kansas, Forenede Stater, 66720
        • Cancer Center of Kansas, P.A. - Chanute
      • Dodge City, Kansas, Forenede Stater, 67801
        • Cancer Center of Kansas, P.A. - Dodge City
      • El Dorado, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas, P.A. - El Dorado
      • Kingman, Kansas, Forenede Stater, 67068
        • Cancer Center of Kansas, P.A. - Kingman
      • Liberal, Kansas, Forenede Stater, 67901
        • Southwest Medical Center
      • Newton, Kansas, Forenede Stater, 67114
        • Cancer Center of Kansas, P.A. - Newton
      • Parsons, Kansas, Forenede Stater, 67357
        • Cancer Center of Kansas, P.A. - Parsons
      • Pratt, Kansas, Forenede Stater, 67124
        • Cancer Center of Kansas, P.A. - Pratt
      • Salina, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas, P.A. - Salina
      • Wellington, Kansas, Forenede Stater, 67152
        • Cancer Center of Kansas, P.A. - Wellington
      • Wichita, Kansas, Forenede Stater, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas, P.A. - Wichita
      • Wichita, Kansas, Forenede Stater, 67203
        • Associates in Womens Health, P.A. - North Review
      • Wichita, Kansas, Forenede Stater, 67208
        • Cancer Center of Kansas, P.A. - Medical Arts Tower
      • Winfield, Kansas, Forenede Stater, 67156
        • Cancer Center of Kansas, P.A. - Winfield
    • Michigan
      • Adrian, Michigan, Forenede Stater, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Lambertville, Michigan, Forenede Stater, 48144
        • Haematology-Oncology Associates of Ohio and Michigan, P.C.
      • Monroe, Michigan, Forenede Stater, 48162
        • Community Cancer Center of Monroe
      • Monroe, Michigan, Forenede Stater, 48162
        • Mercy Memorial Hospital System
    • Minnesota
      • Alexandria, Minnesota, Forenede Stater, 56308
      • Bemidji, Minnesota, Forenede Stater, 56601
        • MeritCare Clinic - Bemidji
      • Brainerd, Minnesota, Forenede Stater, 56401
        • Brainerd Medical Center
      • Brainerd, Minnesota, Forenede Stater, 56401
        • St. Joseph's Medical Center
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forenede Stater, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Edina, Minnesota, Forenede Stater, 55435
        • Fairview Southdale Hospital
      • Fergus Falls, Minnesota, Forenede Stater, 56537
      • Fridley, Minnesota, Forenede Stater, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, Forenede Stater, 55350
        • Hutchinson Area Health Care
      • Lichfield, Minnesota, Forenede Stater, 55355
        • Meeker County Memorial Hospital
      • Maplewood, Minnesota, Forenede Stater, 55109
        • St. John's Hospital
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Hennepin County Medical Center - Minneapolis
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
      • Montevideo, Minnesota, Forenede Stater, 56265
        • Chippewa County - Montevideo Hospital
      • Robbinsdale, Minnesota, Forenede Stater, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • Coborn Cancer Center
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • CCOP - Metro-Minnesota
      • Shakopee, Minnesota, Forenede Stater, 55379
        • Saint Francis Cancer Center
      • St Paul, Minnesota, Forenede Stater, 55102
        • St. Joseph's Hospital
      • St. Cloud, Minnesota, Forenede Stater, 56303
        • CentraCare Clinic - River Campus
      • St. Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Health Services
      • St. Paul, Minnesota, Forenede Stater, 55102
        • United Hospital
      • St. Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital Cancer Care Center
      • Waconia, Minnesota, Forenede Stater, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Woodwinds Health Campus
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Cancer Care Center at Medcenter One Hospital
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Mid Dakota Clinic, P. C.
      • Bismarck, North Dakota, Forenede Stater, 58502
        • St. Alexius Medical Center
      • Fargo, North Dakota, Forenede Stater, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, Forenede Stater, 58122
        • MeritCare Medical Group
      • Grand Forks, North Dakota, Forenede Stater, 58201
        • Altru Cancer Center at Altru Hospital
    • Ohio
      • Bowling Green, Ohio, Forenede Stater, 43402
        • Wood County Oncology Center
      • Dayton, Ohio, Forenede Stater, 45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton, Ohio, Forenede Stater, 45405
        • Grandview Hospital
      • Dayton, Ohio, Forenede Stater, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, Forenede Stater, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, Forenede Stater, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, Forenede Stater, 45429
        • CCOP - Dayton
      • Findlay, Ohio, Forenede Stater, 45840
        • Blanchard Valley Medical Associates
      • Fremont, Ohio, Forenede Stater, 43420
        • Fremont Memorial Hospital
      • Kenton, Ohio, Forenede Stater, 43326
        • Kenton Oncology, Incorporated
      • Kettering, Ohio, Forenede Stater, 45429
        • Charles F. Kettering Memorial Hospital
      • Lima, Ohio, Forenede Stater, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, Forenede Stater, 43537
        • Northwest Ohio Oncology Center
      • Maumee, Ohio, Forenede Stater, 43537
        • St. Luke's Hospital
      • Middletown, Ohio, Forenede Stater, 45044
        • Middletown Regional Hospital
      • Oregon, Ohio, Forenede Stater, 43616
        • St. Charles Mercy Hospital
      • Oregon, Ohio, Forenede Stater, 43616
        • Toledo Clinic - Oregon
      • Sandusky, Ohio, Forenede Stater, 44870
        • Firelands Regional Medical Center
      • Sandusky, Ohio, Forenede Stater, 44870
        • North Coast Cancer Care, Incorporated
      • Sylvania, Ohio, Forenede Stater, 43560
        • Promedica Cancer Center at Flower Hospital
      • Tiffin, Ohio, Forenede Stater, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, Forenede Stater, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, Forenede Stater, 43606
        • Toledo Hospital
      • Toledo, Ohio, Forenede Stater, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo, Ohio, Forenede Stater, 43623
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, Forenede Stater, 43614
        • Medical College of Ohio Cancer Institute
      • Toledo, Ohio, Forenede Stater, 43623
        • Toledo Surgical Specialists
      • Troy, Ohio, Forenede Stater, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wauseon, Ohio, Forenede Stater, 43567
        • Fulton County Health Center
      • Xenia, Ohio, Forenede Stater, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
      • Danville, Pennsylvania, Forenede Stater, 17822-0001
        • Geisinger Medical Center
      • State College, Pennsylvania, Forenede Stater, 16801
        • Geisinger Medical Group
      • Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5039
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, Forenede Stater, 57105-1080
        • Avera McKennan Hospital and University Health Center
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Medical X-Ray Center, P. C.
    • Wisconsin
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Franciscan Skemp Healthcare

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år til 120 år (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

    • Metastatic or unresectable disease

  • Measurable disease

    • At least 1 lesion at least 2.0 cm
    • Disease must be completely outside prior radiotherapy port OR documented disease progression since the completion of radiotherapy
  • No meningeal carcinomatosis

  • No untreated brain metastases

    • Current metastatic CNS disease must have been treated and clinically stable for at least 2 weeks prior to study chemotherapy
  • No potentially curative treatment options available (e.g., chemotherapy with surgery or radiotherapy)

PATIENT CHARACTERISTICS:

Age

  • 65 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • No uncontrolled hepatic disease

Renal

  • Creatinine no greater than 2 times upper limit of normal
  • No uncontrolled renal disease

Cardiovascular

  • No uncontrolled cardiac disease

Pulmonary

  • No clinically active interstitial lung disease

    • Asymptomatic, chronic stable radiographic changes allowed
  • No uncontrolled respiratory disease

Other

  • Fertile patients must use effective contraception
  • Able and willing to complete questionnaires alone or with assistance
  • No known hypersensitivity to gefitinib or any of its excipients
  • No active infection within the past 2 weeks
  • No other prior malignancy within the past 5 years except basal cell skin cancer
  • No grade 2 or greater peripheral neuropathy (CTC v2.0)
  • No uncontrolled diabetes mellitus (for patients receiving study chemotherapy)
  • No dysphagia or inability to swallow intact capsules
  • No significant medical condition that would preclude study treatment or follow-up
  • No severe or uncontrolled systemic disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • No prior chemotherapy for metastatic NSCLC

Endocrine therapy

  • Concurrent steroids allowed provided the dose is not changed

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 25% of marrow-containing skeleton
  • No concurrent radiotherapy (including palliative)

Surgery

  • See Disease Characteristics
  • At least 3 weeks since prior major surgery
  • No surgery within 7 days after study participation

Other

  • More than 30 days since prior non-FDA approved investigational drugs
  • No concurrent oral retinoids

  • No concurrent CYP3A4-inducing agents, including the following:

    • Carbamazepine
    • Oxcarbazepine
    • Modafinil
    • Ethosuximide
    • Griseofulvin
    • Nafcillin
    • Phenobarbital
    • Phenylbutazone
    • Phenytoin
    • Primidone
    • Rifampin
    • Hypericum perforatum (St. John's wort)
    • Barbiturates
    • Sulfinpyrazone
  • No concurrent drugs that cause sustained elevation of gastric pH (≥ 5)
  • No concurrent antacids within 4 hours before, during, and within 4 hours after gefitinib administration
  • No concurrent itraconazole, fluconazole, ketoconazole, or erythromycin

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: gefitinib

Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and after the completion of course 2.

Patients are followed every 3 months for 5 years.
Medicin: gefitinib
Eksperimentel: paclitaxel + carboplatin + gefitinib

Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of chemotherapy and in the absence of disease progression, patients receive oral gefitinib as in group I.

Quality of life is assessed at baseline and after the completion of course 2.

Patients are followed every 3 months for 5 years.
Medicin: carboplatin
Medicin: paclitaxel
Medicin: gefitinib

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Progression status at 6 months
Tidsramme: at 6 months
at 6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Progressionsfri overlevelse
Tidsramme: Op til 5 år
Op til 5 år
Samlet overlevelse
Tidsramme: Op til 5 år
Op til 5 år
Confirmed response rate (complete or partial response)
Tidsramme: Up to 5 years
Up to 5 years
Quality of life as assessed by the Lung Cancer Symptom scale
Tidsramme: Up to 5 years
Up to 5 years
Social support measure as assessed by the Lubben Social Network scale
Tidsramme: Up to 5 years
Up to 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2004

Primær færdiggørelse (Faktiske)

1. august 2006

Studieafslutning (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

5. juni 2003

Først indsendt, der opfyldte QC-kriterier

5. juni 2003

Først opslået (Skøn)

6. juni 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCCTG-N0222
  • NCI-2012-02535 (Registry Identifier: CTRP (Clinical Trials Reporting System))
  • CDR0000304453 (Registry Identifier: PDQ (Physician Data Query))

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 .

Kliniske forsøg med Lungekræft

Kliniske forsøg med carboplatin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Senegal

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner