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

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City of Hope

Status

Withdrawn

Conditions

Stage IIIA Non-small Cell Lung Cancer

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01314677
10012 (Registry Identifier)
NCI-2011-00337 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 3 patient groups

Group A (FDG PET/CT between RT fractions 5-6)
Experimental group
Description:
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.
Treatment:
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography/computed tomography (PET/CT)
Group B (FDG PET/CT between RT fractions 10-11)
Experimental group
Description:
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.
Treatment:
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography/computed tomography (PET/CT)
Group C (FDG PET/CT between RT fractions 15-16)
Experimental group
Description:
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.
Treatment:
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography/computed tomography (PET/CT)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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