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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 febbraio 2011 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

250

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

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

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: Diagnostico
  • Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

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

Misure di risultato secondarie

Misura del risultato
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

Collaboratori e investigatori

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

Sponsor

American College of Radiology Imaging Network

Collaboratori

National Cancer Institute (NCI)
Radiation Therapy Oncology Group

Investigatori

  • Cattedra di studio: Mitchell Machtay, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

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 marzo 2005

Completamento primario (Anticipato)

1 giugno 2006

Date di iscrizione allo studio

Primo inviato

14 maggio 2004

Primo inviato che soddisfa i criteri di controllo qualità

14 maggio 2004

Primo Inserito (Stima)

17 maggio 2004

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

1 marzo 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 febbraio 2011

Ultimo verificato

1 ottobre 2007

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CDR0000362061
  • ACRIN-6668
  • RTOG-0235

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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