- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00083083
Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
- Arzneimittel: Carboplatin
- Genetisch: Genexpressionsanalyse
- Arzneimittel: Docetaxel
- Strahlung: Strahlentherapie
- Arzneimittel: Etoposid
- Arzneimittel: Cisplatin
- Arzneimittel: Paclitaxel
- Strahlung: Fludeoxyglucose F 18
- Verfahren: Positronen-Emissions-Tomographie
- Arzneimittel: Vinorelbintartrat
- Arzneimittel: Vinblastinsulfat
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Alberta
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Calgary, Alberta, Kanada, T2N 4N2
- Tom Baker Cancer Centre - Calgary
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Ontario
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Kitchner, Ontario, Kanada, N2G 1G3
- Grand River Regional Cancer Centre at Grand River Hospital
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Goyang, Korea, Republik von, 410-769
- National Cancer Center - Korea
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Scottsdale, Arizona, Vereinigte Staaten, 85262
- Scottsdale Medical Imaging, Limited
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California
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Los Angeles, California, Vereinigte Staaten, 90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
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Sacramento, California, Vereinigte Staaten, 95816
- Radiological Associates of Sacramento Medical Group at Sutter Cancer Center
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Connecticut
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New Haven, Connecticut, Vereinigte Staaten, 06511
- Hospital of Saint Raphael
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Florida
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Boynton Beach, Florida, Vereinigte Staaten, 33435
- Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital
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Dearfield Beach, Florida, Vereinigte Staaten, 33064-3596
- North Broward Medical Center
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Jacksonville, Florida, Vereinigte Staaten, 32207
- Integrated Community Oncology Network at Baptist Cancer Institute
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Tallahassee, Florida, Vereinigte Staaten, 32308
- Tallahassee Memorial Hospital
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60612
- Rush Cancer Institute at Rush University Medical Center
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Indiana
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Anderson, Indiana, Vereinigte Staaten, 46016
- Saint John's Cancer Center at Saint John's Medical Center
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Goshen, Indiana, Vereinigte Staaten, 46526
- Center for Cancer Care at Goshen General Hospital
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South Bend, Indiana, Vereinigte Staaten, 46601
- CCOP - Northern Indiana CR Consortium
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Vereinigte Staaten, 02129
- Dana-Farber Partners Cancer Care
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South Weymouth, Massachusetts, Vereinigte Staaten, 02190
- South Shore Hospital
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Michigan
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Detroit, Michigan, Vereinigte Staaten, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Kalamazoo, Michigan, Vereinigte Staaten, 49007-3731
- West Michigan Cancer Center
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Royal Oak, Michigan, Vereinigte Staaten, 48073
- William Beaumont Hospital - Royal Oak Campus
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Missouri
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St. Louis, Missouri, Vereinigte Staaten, 63110
- Mallinckrodt Institute of Radiology at Washington University Medical Center
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Nevada
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Reno, Nevada, Vereinigte Staaten, 89502
- Renown Institute for Cancer at Renown Regional Medical Center
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New Hampshire
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Lebanon, New Hampshire, Vereinigte Staaten, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Teaneck, New Jersey, Vereinigte Staaten, 07666
- Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
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Toms River, New Jersey, Vereinigte Staaten, 08755
- J. Phillip Citta Regional Cancer Center at Community Medical Center
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Ohio
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Akron, Ohio, Vereinigte Staaten, 44302
- McDowell Cancer Center at Akron General Medical Center
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Cleveland, Ohio, Vereinigte Staaten, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Vereinigte Staaten, 44111
- Cleveland Clinic Cancer Center at Fairview Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Vereinigte Staaten, 97239-3098
- Knight Cancer Institute At Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19111-2497
- Fox Chase Cancer Center - Philadelphia
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19141
- Albert Einstein Cancer Center
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15232
- UPMC Cancer Centers
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Wynnewood, Pennsylvania, Vereinigte Staaten, 19096
- Lankenau Cancer Center at Lankenau Hospital
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Rhode Island
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Providence, Rhode Island, Vereinigte Staaten, 02908-4735
- Roger Williams Medical Center
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Providence, Rhode Island, Vereinigte Staaten, 02912
- Brown University School of Medicine
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South Carolina
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Charleston, South Carolina, Vereinigte Staaten, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Spartanburg, South Carolina, Vereinigte Staaten, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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Tennessee
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Nashville, Tennessee, Vereinigte Staaten, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Dallas, Texas, Vereinigte Staaten, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Houston, Texas, Vereinigte Staaten, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Utah
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Salt Lake City, Utah, Vereinigte Staaten, 84112
- Huntsman Cancer Institute at University of Utah
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Virginia
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Richmond, Virginia, Vereinigte Staaten, 23226
- Bon Secours Cancer Institute at St. Mary's Hospital
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Wisconsin
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Madison, Wisconsin, Vereinigte Staaten, 53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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Waukesha, Wisconsin, Vereinigte Staaten, 53188
- Waukesha Memorial Hospital Regional Cancer Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Maskierung: Keine (Offenes Etikett)
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
---|
Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
---|
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
|
Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Mitchell Machtay, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen der Atemwege
- Neubildungen
- Lungenkrankheit
- Neubildungen nach Standort
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Lungentumoren
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Tubulin-Modulatoren
- Antimitotische Mittel
- Mitose-Modulatoren
- Antineoplastische Mittel, Phytogen
- Topoisomerase-II-Inhibitoren
- Topoisomerase-Inhibitoren
- Radiopharmaka
- Docetaxel
- Carboplatin
- Etoposid
- Paclitaxel
- Fluordeoxyglucose F18
- Vinorelbin
- Vinblastin
Andere Studien-ID-Nummern
- CDR0000362061
- ACRIN-6668
- RTOG-0235
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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