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This study has been withdrawn prior to enrollment.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
  Purpose

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


Condition Intervention
Stage IIIA Non-small Cell Lung Cancer
Procedure: positron emission tomography/computed tomography (PET/CT)
Radiation: fludeoxyglucose F 18

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: April 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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.

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 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.

Procedure: positron emission tomography/computed tomography (PET/CT)
Undergo FDG PET/CT
Radiation: fludeoxyglucose F 18
Undergo FDG PET/CT
Other Names:
  • 18FDG
  • FDG

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314677

Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Khanh Nguyen City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01314677     History of Changes
Other Study ID Numbers: 10012, NCI-2011-00337
Study First Received: March 11, 2011
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 26, 2014