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Fludeoxyglucose F 18 PET/CT Scans in Predicting Therapy Response in Patients With Stage IIIA Non-Small Cell Lung Cancer Undergoing Chemoradiation

27. juni 2012 opdateret af: City of Hope Medical Center

Open Label Randomized Trial of Early Assessment of Therapy Response Using 18FDG-PET/CT in Patients With Marginally Resectable Stage IIIA (N2) Non-Small Cell Lung Cancer (NSCLC) Treated With Induction Concurrent Chemoradiation Followed by Resection and Adjuvant Chemotherapy

This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/computed tomography (CT) in predicting chemoradiation therapy (CRT) failure in patients with stage IIIA non-small cell lung cancer (NSCLC). Diagnostic procedures, such as FDG PET/CT, may help predict CRT failure. Comparing diagnostic results during CRT may help doctors predict a patient's response to treatment and help plan the best treatment

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVES:

I. To determine whether early response of the research positron emission tomography (PET)-computed tomography(CT) scan measured by change in Standard Uptake Value (SUV)max relative to baseline scan can predict induction chemoradiation therapy (CRT) failures sooner than post-treatment PET-CT scan.

II. To determine the optimal timing for 18FDG PET-CT that best predicts for induction CRT failure.

SECONDARY OBJECTIVES:

I. To correlate early 18 fludeoxyglucose (FDG) PET-CT response metrics with pathologic response, progression-free survival separately for: induction CRT failures vs. non-failures, or overall survival separately for induction CRT failures vs. non-failures.

OUTLINE: Patients are randomized to 1 of 3 groups.

Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy.

GROUP A: Patients undergo a FDG PET/CT scan between RT fractions 5-6 (before course 2 of chemotherapy).

GROUP B: Patients undergo a FDG PET/CT scan between RT fractions 10-11 (before course 3 of chemotherapy).

GROUP C: Patients undergo a FDG PET/CT scan between RT fractions 15-16 (before course 4 of chemotherapy).

Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • All patients with marginally resectable IIIA (N2) NSCLC undergoing induction CRT will be eligible for this imaging trial; patients will be screened by the chest tumor board for entry
  • Undergoing or plan to undergo induction chemoradiation

Exclusion Criteria:

  • Poorly controlled or uncontrolled diabetes mellitus, with blood glucose > 200 mg/dl
  • Have allergies or medical contra-indications to FDG or intravenous (IV) contrast
  • Medical contra-indications to obtaining CT or PET scans
  • Pre-authorization denial of coverage by insurance providers of clinical staging and restaging PET-CT scans

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
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group A (FDG PET/CT between RT fractions 5-6)

Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy.

Patients undergo a FDG PET/CT scan between RT fractions 5-6 (before course 2 of chemotherapy).

Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection.
Stråling: fludeoxyglucose F 18
Gennemgå FDG PET/CT
Andre navne:
  • 18FDG
  • FDG
Procedure: positron emission tomography/computed tomography (PET/CT)
Undergo FDG PET/CT
Eksperimentel: Group B (FDG PET/CT between RT fractions 10-11)

Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy.

Patients undergo a FDG PET/CT scan between RT fractions 10-11 (before course 3 of chemotherapy).

Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection.
Stråling: fludeoxyglucose F 18
Gennemgå FDG PET/CT
Andre navne:
  • 18FDG
  • FDG
Procedure: positron emission tomography/computed tomography (PET/CT)
Undergo FDG PET/CT
Eksperimentel: Group C (FDG PET/CT between RT fractions 15-16)

Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy.

Patients undergo a FDG PET/CT scan between RT fractions 15-16 (before course 4 of chemotherapy).

Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection.
Stråling: fludeoxyglucose F 18
Gennemgå FDG PET/CT
Andre navne:
  • 18FDG
  • FDG
Procedure: positron emission tomography/computed tomography (PET/CT)
Undergo FDG PET/CT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Induction therapy failure
Tidsramme: 6 weeks after completion of chemoradiation therapy (CRT)
Defined as any evidence by clinically unresectable disease based on tumor board consensus and review of restaging scans demonstrating locoregional progression or distant metastasis, surgically unresectable disease based on surgical exploration, or suboptimal resection disease still requiring pneumonectomy and still having R1 resection.
6 weeks after completion of chemoradiation therapy (CRT)
Early positron emission tomography (PET) response of group A
Tidsramme: Baseline and between standard radiotherapy (RT) fractions 5-6
Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
Baseline and between standard radiotherapy (RT) fractions 5-6
Early positron emission tomography (PET) response of group B
Tidsramme: Baseline and between standard radiotherapy (RT) fractions 10-11
Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
Baseline and between standard radiotherapy (RT) fractions 10-11
Early positron emission tomography (PET) response of group C
Tidsramme: Baseline and between standard radiotherapy (RT) fractions 15-16
Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
Baseline and between standard radiotherapy (RT) fractions 15-16

Sekundære resultatmål

Resultatmål
Tidsramme
Pathologic response
Tidsramme: 6 weeks after completion of chemoradiation therapy (CRT)
6 weeks after completion of chemoradiation therapy (CRT)
Progression-free survival
Tidsramme: Every 3 months for 2 years and every 6 months thereafter
Every 3 months for 2 years and every 6 months thereafter
Overall survival
Tidsramme: Every 3 months for 2 years and every 6 months thereafter
Every 3 months for 2 years and every 6 months thereafter

Samarbejdspartnere og efterforskere

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

Sponsor

City of Hope Medical Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Khanh Nguyen, City of Hope Medical Center

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. april 2011

Primær færdiggørelse (Faktiske)

1. juni 2012

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

11. marts 2011

Først indsendt, der opfyldte QC-kriterier

11. marts 2011

Først opslået (Skøn)

14. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. juni 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juni 2012

Sidst verificeret

1. juni 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 10012 (DAIDS ES)
  • NCI-2011-00337 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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 .

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