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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ClinicalTrials.gov Identifier: NCT01314677 |
Recruitment Status
:
Withdrawn
(No subjects have been accrued to this trial. The PI will no longer be at COH and requests a study withdrawal/closure.)
First Posted
: March 14, 2011
Last Update Posted
: June 29, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stage IIIA Non-small Cell Lung Cancer | Procedure: positron emission tomography/computed tomography (PET/CT) Radiation: fludeoxyglucose F 18 | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | April 2011 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

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. |
Procedure: positron emission tomography/computed tomography (PET/CT)
Undergo FDG PET/CT
Radiation: fludeoxyglucose F 18
Undergo FDG PET/CT
Other Names:
|
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:
|
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:
|
- 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.
- 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.
- 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.
- 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.
- Pathologic response [ Time Frame: 6 weeks after completion of chemoradiation therapy (CRT) ]
- Progression-free survival [ Time Frame: 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 ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01314677
Principal Investigator: | Khanh Nguyen | City of Hope Medical Center |
Responsible Party: | City of Hope Medical Center |
ClinicalTrials.gov Identifier: | NCT01314677 History of Changes |
Other Study ID Numbers: |
10012 NCI-2011-00337 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
First Posted: | March 14, 2011 Key Record Dates |
Last Update Posted: | June 29, 2012 |
Last Verified: | June 2012 |
Additional relevant MeSH terms:
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Fluorodeoxyglucose F18 Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |