- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00310219
Positron Emission Tomography Scan and CT Scan in Planning Radiation Therapy for Patients With Stage II or Stage III Non-Small Cell Lung Cancer
Comparative Study of Gross Tumor Volume Definition With or Without PET Fusion for Patients With Non-Small Cell Lung Carcinoma
RATIONALE: Imaging procedures, such as positron emission tomography (PET) scan and CT scan, may help doctors plan radiation therapy for patients with non-small cell lung cancer.
PURPOSE: This clinical trial is studying how well a combined PET scan and CT scan works compared to a CT scan alone in planning radiation therapy for patients with stage II or stage III non-small cell lung cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
Primary
- Determine the impact of positron emission tomography (PET)/CT fusion scan and CT scan alone, by comparing gross tumor volume (GTV) contours and three-dimensional conformal radiotherapy treatment plans using 2 separate data sets (PET/CT fusion scan and CT scan only), in patients with stage II or III non-small cell lung cancer who are planning to undergo radiotherapy.
- Determine the impact of PET on GTV (cm^3), number of involved nodes, location of involved nodes, and dosimetric measures of normal tissue toxicity (mean lung dose, V20, and mean esophageal dose).
Secondary
- Determine the rate of elective nodal failures (nodal failures in regions that are not intentionally irradiated to definitive doses [i.e., ipsilateral hilum, mediastinum, or ipsilateral supraclavicular fossa]).
OUTLINE: This is a multicenter study. Patients are stratified according to neoadjuvant chemotherapy (yes vs no).
Patients undergo a combined positron emission tomography (PET)/CT scan. Patients also undergo a CT scan alone. A single three-dimensional conformal radiotherapy (3DCRT) plan is generated from the combined PET/CT scan results. A single 3DCRT plan using the planning target volume is derived from the CT scan only.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Montreal, Canada, H2W 1S6
- McGill Cancer Centre at McGill University
-
-
-
-
Missouri
-
St Louis, Missouri, Forente stater, 63110
- Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
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Texas
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Dallas, Texas, Forente stater, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Wisconsin
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Madison, Wisconsin, Forente stater, 53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIA/IIB or stage IIIA/IIIB disease
- Planning to undergo radiotherapy
- Local or regional nodal recurrence after surgery allowed
- No malignant pleural effusion
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Negative pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent neoadjuvant and/or concurrent chemotherapy allowed
- No concurrent intensity-modulated radiotherapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Arm 1
Two radiation oncologists are randomly assigned to develop either a 3DCRT plan using CT only, or a 3DCRT plan using fused PET/CT
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The impact of positron emission tomography (PET)/CT fusion planning on GTV (cm³) vs. planning with CT scan alone
Tidsramme: Two treatment plans are centrally reviewed to determine the difference in gross tumor volume between the plans
|
Two treatment plans are centrally reviewed to determine the difference in gross tumor volume between the plans
|
The impact of positron emission tomography (PET)/CT fusion planning on number of contoured lymph nodes vs. planning with CT scan alone
Tidsramme: Two treatment plans are centrally reviewed to determine the difference in number of contoured lymph nodes between the plans
|
Two treatment plans are centrally reviewed to determine the difference in number of contoured lymph nodes between the plans
|
The impact of positron emission tomography (PET)/CT fusion planning on location of involved lymph nodes vs planning with CT scan alone
Tidsramme: Two treatment plans are centrally reviewed to determine the difference in location of involved lymph nodes between the plans
|
Two treatment plans are centrally reviewed to determine the difference in location of involved lymph nodes between the plans
|
The impact of positron emission tomography (PET)/CT fusion planning on lung V20 vs planning with CT scan alone
Tidsramme: Two treatment plans are centrally reviewed to determine the difference in lung V20 between the plans
|
Two treatment plans are centrally reviewed to determine the difference in lung V20 between the plans
|
The impact of positron emission tomography (PET)/CT fusion planning vs planning with CT scan alone on mean esophagus dose
Tidsramme: Two treatment plans are centrally reviewed to determine the difference in mean esophagus dose between the plans
|
Two treatment plans are centrally reviewed to determine the difference in mean esophagus dose between the plans
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Rate of elective nodal failures as assessed by failure in previously uninvolved regional lymph nodes at 2 years
Tidsramme: From registration to 2 years
|
From registration to 2 years
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jeffrey Bradley, MD, Mallinckrodt Institute of Radiology at Washington University Medical Center
- Studiestol: Jacqueline Brunetti, MD, Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RTOG-0515
- CDR0000465501
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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