Fludeoxyglucose F 18 PET/CT Scans in Predicting Therapy Response in Patients With Stage IIIA Non-Small Cell Lung Cancer Undergoing Chemoradiation
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
FDG PET/CT unterziehen
Andere Namen:
Undergo FDG PET/CT
|
|
Experimental: 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. |
FDG PET/CT unterziehen
Andere Namen:
Undergo FDG PET/CT
|
|
Experimental: 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. |
FDG PET/CT unterziehen
Andere Namen:
Undergo FDG PET/CT
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Induction therapy failure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Pathologic response
Zeitfenster: 6 weeks after completion of chemoradiation therapy (CRT)
|
6 weeks after completion of chemoradiation therapy (CRT)
|
|
Progression-free survival
Zeitfenster: Every 3 months for 2 years and every 6 months thereafter
|
Every 3 months for 2 years and every 6 months thereafter
|
|
Overall survival
Zeitfenster: Every 3 months for 2 years and every 6 months thereafter
|
Every 3 months for 2 years and every 6 months thereafter
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Khanh Nguyen, City of Hope Medical Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
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
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen der Atemwege
- Neubildungen
- Lungenkrankheit
- Neubildungen nach Standort
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Karzinom, bronchogen
- Bronchiale Neubildungen
- Lungentumoren
- Karzinom, nicht-kleinzellige Lunge
- Molekulare Mechanismen der pharmakologischen Wirkung
- Radiopharmaka
- Fluordeoxyglucose F18
Andere Studien-ID-Nummern
- 10012 (DAIDS ES)
- NCI-2011-00337 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
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