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

June 27, 2012 updated by: 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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Radiation: fludeoxyglucose F 18
Undergo FDG PET/CT
Other Names:
  • 18FDG
  • FDG
Procedure: positron emission tomography/computed tomography (PET/CT)
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.
Radiation: fludeoxyglucose F 18
Undergo FDG PET/CT
Other Names:
  • 18FDG
  • FDG
Procedure: positron emission tomography/computed tomography (PET/CT)
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.
Radiation: fludeoxyglucose F 18
Undergo FDG PET/CT
Other Names:
  • 18FDG
  • FDG
Procedure: positron emission tomography/computed tomography (PET/CT)
Undergo FDG PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction therapy failure
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Khanh Nguyen, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 11, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (Estimate)

March 14, 2011

Study Record Updates

Last Update Posted (Estimate)

June 29, 2012

Last Update Submitted That Met QC Criteria

June 27, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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