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

This study has been withdrawn prior to enrollment.
(No subjects have been accrued to this trial. The PI will no longer be at COH and requests a study withdrawal/closure.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01314677
First received: March 11, 2011
Last updated: June 27, 2012
Last verified: June 2012

March 11, 2011
June 27, 2012
April 2011
June 2012   (final data collection date for primary outcome measure)
  • Induction therapy failure [ Time Frame: 6 weeks after completion of chemoradiation therapy (CRT) ] [ Designated as safety issue: No ]
    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.
  • Early positron emission tomography (PET) response of group A [ Time Frame: Baseline and between standard radiotherapy (RT) fractions 5-6 ] [ Designated as safety issue: No ]
    Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
  • Early positron emission tomography (PET) response of group B [ Time Frame: Baseline and between standard radiotherapy (RT) fractions 10-11 ] [ Designated as safety issue: No ]
    Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
  • Early positron emission tomography (PET) response of group C [ Time Frame: Baseline and between standard radiotherapy (RT) fractions 15-16 ] [ Designated as safety issue: No ]
    Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
Same as current
Complete list of historical versions of study NCT01314677 on ClinicalTrials.gov Archive Site
  • Pathologic response [ Time Frame: 6 weeks after completion of chemoradiation therapy (CRT) ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Every 3 months for 2 years and every 6 months thereafter ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 3 months for 2 years and every 6 months thereafter ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Stage IIIA Non-small Cell Lung Cancer
  • Procedure: positron emission tomography/computed tomography (PET/CT)
    Undergo FDG PET/CT
  • Radiation: fludeoxyglucose F 18
    Undergo FDG PET/CT
    Other Names:
    • 18FDG
    • FDG
  • 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.

    Interventions:
    • Procedure: positron emission tomography/computed tomography (PET/CT)
    • Radiation: fludeoxyglucose F 18
  • 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.

    Interventions:
    • Procedure: positron emission tomography/computed tomography (PET/CT)
    • Radiation: fludeoxyglucose F 18
  • 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.

    Interventions:
    • Procedure: positron emission tomography/computed tomography (PET/CT)
    • Radiation: fludeoxyglucose F 18
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01314677
10012, NCI-2011-00337
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Khanh Nguyen City of Hope Medical Center
City of Hope Medical Center
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP