Positron Emission Tomography Scan and CT Scan in Planning Radiation Therapy for Patients With Stage II or Stage III Non-Small Cell Lung Cancer
23 januari 2014 uppdaterad av: Radiation Therapy Oncology Group
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
52
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Missouri
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St Louis, Missouri, Förenta staterna, 63110
- Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
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Texas
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Dallas, Texas, Förenta staterna, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
-
Wisconsin
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Madison, Wisconsin, Förenta staterna, 53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
-
-
-
-
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Montreal, Kanada, H2W 1S6
- McGill Cancer Centre at McGill University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The impact of positron emission tomography (PET)/CT fusion planning on GTV (cm³) vs. planning with CT scan alone
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Rate of elective nodal failures as assessed by failure in previously uninvolved regional lymph nodes at 2 years
Tidsram: From registration to 2 years
|
From registration to 2 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: 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
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2006
Primärt slutförande (Faktisk)
1 november 2010
Avslutad studie (Faktisk)
1 november 2013
Studieregistreringsdatum
Först inskickad
29 mars 2006
Först inskickad som uppfyllde QC-kriterierna
29 mars 2006
Första postat (Uppskatta)
3 april 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
24 januari 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 januari 2014
Senast verifierad
1 januari 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RTOG-0515
- CDR0000465501
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .