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Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer

26. februar 2011 opdateret af: American College of Radiology Imaging Network

Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma

RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography (^18FDG-PET), may improve the ability to detect disease progression and help doctors predict a patient's response to treatment and plan more effective treatment.

PURPOSE: This phase II trial is studying how well ^18FDG-PET imaging works in detecting disease progression and determining response to treatment in patients who are undergoing chemoradiotherapy for locally advanced non-small cell lung cancer.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine whether peak standardized uptake value (SUV) for fludeoxyglucose F 18 positron emission tomography (FDG-PET) shortly after definitive chemoradiotherapy is predictive of long-term survival of patients with inoperable stage IIB or III non-small cell lung cancer.

Secondary

  • Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients.
  • Determine whether post-treatment imaging using peak and max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of local disease control in these patients.
  • Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients.
  • Correlate, if possible, Ki-67 expression with overall survival of patients assessed with these imaging techniques.

OUTLINE: This is a diagnostic, multicenter study.

Before starting chemoradiotherapy, patients undergo baseline whole-body positron emission tomography (PET) imaging. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed 50-70 minutes later by PET imaging. Patients then receive concurrent definitive radiotherapy and chemotherapy. Patients enrolled in other treatment-oriented clinical trials receive therapy as per that trial. Other patients receive standard thoracic radiotherapy (dose ≥ 60 Gy) and standard chemotherapy comprising a platin (cisplatin or carboplatin) and a second non-platin, non-gemcitabine drug (etoposide, vinblastine, vinorelbine, paclitaxel, or docetaxel). Approximately 14 weeks after completion of chemoradiotherapy and adjuvant chemotherapy (if given), patients undergo post-treatment ^18FDG-PET imaging.

Patients are followed every 3 months for 2 years and then every 6 months for at least 1 year.

PROJECTED ACCRUAL: A total of 250 patients (including at least 75 with stage IIB/IIIA disease and at least 75 with stage IIIB disease) will be accrued for this study within 2 years.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

250

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre - Calgary
    • Ontario
      • Kitchner, Ontario, Canada, N2G 1G3
        • Grand River Regional Cancer Centre at Grand River Hospital
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85262
        • Scottsdale Medical Imaging, Limited
    • California
      • Los Angeles, California, Forenede Stater, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Sacramento, California, Forenede Stater, 95816
        • Radiological Associates of Sacramento Medical Group at Sutter Cancer Center
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06511
        • Hospital of Saint Raphael
    • Florida
      • Boynton Beach, Florida, Forenede Stater, 33435
        • Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital
      • Dearfield Beach, Florida, Forenede Stater, 33064-3596
        • North Broward Medical Center
      • Jacksonville, Florida, Forenede Stater, 32207
        • Integrated Community Oncology Network at Baptist Cancer Institute
      • Tallahassee, Florida, Forenede Stater, 32308
        • Tallahassee Memorial Hospital
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush Cancer Institute at Rush University Medical Center
    • Indiana
      • Anderson, Indiana, Forenede Stater, 46016
        • Saint John's Cancer Center at Saint John's Medical Center
      • Goshen, Indiana, Forenede Stater, 46526
        • Center for Cancer Care at Goshen General Hospital
      • South Bend, Indiana, Forenede Stater, 46601
        • CCOP - Northern Indiana CR Consortium
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Forenede Stater, 02129
        • Dana-Farber Partners Cancer Care
      • South Weymouth, Massachusetts, Forenede Stater, 02190
        • South Shore Hospital
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49007-3731
        • West Michigan Cancer Center
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital - Royal Oak Campus
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63110
        • Mallinckrodt Institute of Radiology at Washington University Medical Center
    • Nevada
      • Reno, Nevada, Forenede Stater, 89502
        • Renown Institute for Cancer at Renown Regional Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Teaneck, New Jersey, Forenede Stater, 07666
        • Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
      • Toms River, New Jersey, Forenede Stater, 08755
        • J. Phillip Citta Regional Cancer Center at Community Medical Center
    • Ohio
      • Akron, Ohio, Forenede Stater, 44302
        • McDowell Cancer Center at Akron General Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44111
        • Cleveland Clinic Cancer Center at Fairview Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma University Cancer Institute
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239-3098
        • Knight Cancer Institute at Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19141
        • Albert Einstein Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • UPMC Cancer Centers
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • Lankenau Cancer Center at Lankenau Hospital
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02908-4735
        • Roger Williams Medical Center
      • Providence, Rhode Island, Forenede Stater, 02912
        • Brown University School of Medicine
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Houston, Texas, Forenede Stater, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute at University of Utah
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23226
        • Bon Secours Cancer Institute at St. Mary's Hospital
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • Waukesha Memorial Hospital Regional Cancer Center
  • Korea, Republikken
      • Goyang, Korea, Republikken, 410-769
        • National Cancer Center - Korea

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

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

    • Clinical stage IIB or III disease
    • No small cell carcinoma
    • No stage IV disease*
    • No diffuse bronchoalveolar subtype
    • No planned definitive surgical resection NOTE: *Patients with evidence of stage IV disease by positron emission tomography are eligible if the evidence cannot be confirmed by other means AND the physician still plans to proceed with definitive chemoradiation

  • Planning treatment with definitive chemoradiotherapy

    • May be treated on another Radiation Therapy Oncology Group protocol (except phase I studies) OR with conventional concurrent NSCLC chemoradiotherapy
    • Radiotherapy ≥ 60 Gy AND chemotherapy to include concurrent platinum-based therapy
  • No brain metastases by head CT scan or MRI

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Medically suitable for early concurrent chemoradiotherapy (radiotherapy dose ≥ 60 Gy)
  • Able to tolerate positron emission tomography imaging
  • No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL)
  • No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No anticipated use of adjuvant biologic therapy beyond 14 weeks after the completion of radiotherapy

Chemotherapy

  • See Disease Characteristics
  • No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of radiotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior thoracic radiotherapy
  • No concurrent intensity-modulated radiotherapy

Surgery

  • See Disease Characteristics

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution

Sekundære resultatmål

Resultatmål
Relationship of survival to post-treatment max SUV as determined by the imaging institute
Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution
Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution
Reliability between peak and max SUV measurements both pre- and post-treatment
Proportion of participants who are either upstaged or downstaged by positron emission tomography scan
Reliability between PET scan-defined response to therapy measurements
Correlation of Ki-67 expression with peak and max pre-treatment SUV
Association between Ki-67 expression and overall survival at 2 years

Samarbejdspartnere og efterforskere

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

Sponsor

American College of Radiology Imaging Network

Samarbejdspartnere

National Cancer Institute (NCI)
Radiation Therapy Oncology Group

Efterforskere

  • Studiestol: Mitchell Machtay, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

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. marts 2005

Primær færdiggørelse (Forventet)

1. juni 2006

Datoer for studieregistrering

Først indsendt

14. maj 2004

Først indsendt, der opfyldte QC-kriterier

14. maj 2004

Først opslået (Skøn)

17. maj 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. marts 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. februar 2011

Sidst verificeret

1. oktober 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000362061
  • ACRIN-6668
  • RTOG-0235

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

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kyrgyzstan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner