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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 dicembre 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

65

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

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

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 65 anni a 120 anni (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

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: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: gefitinib
Sperimentale: 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.
Droga: carboplatino
Droga: paclitaxel
Droga: gefitinib

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Progression status at 6 months
Lasso di tempo: at 6 months
at 6 months

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Sopravvivenza libera da progressione
Lasso di tempo: Fino a 5 anni
Fino a 5 anni
Sopravvivenza globale
Lasso di tempo: Fino a 5 anni
Fino a 5 anni
Confirmed response rate (complete or partial response)
Lasso di tempo: Up to 5 years
Up to 5 years
Quality of life as assessed by the Lung Cancer Symptom scale
Lasso di tempo: Up to 5 years
Up to 5 years
Social support measure as assessed by the Lubben Social Network scale
Lasso di tempo: Up to 5 years
Up to 5 years

Collaboratori e investigatori

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

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

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.

Pubblicazioni generali

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 ottobre 2004

Completamento primario (Effettivo)

1 agosto 2006

Completamento dello studio (Effettivo)

1 novembre 2010

Date di iscrizione allo studio

Primo inviato

5 giugno 2003

Primo inviato che soddisfa i criteri di controllo qualità

5 giugno 2003

Primo Inserito (Stima)

6 giugno 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

14 dicembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 dicembre 2016

Ultimo verificato

1 dicembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

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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Sponsor e collaboratori

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

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