Study Stopped
No subjects have been accrued to this trial. The PI will no longer be at COH and requests a study withdrawal/closure.
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
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
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Started Apr 2011
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2011
CompletedFirst Posted
Study publicly available on registry
March 14, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJune 29, 2012
June 1, 2012
1.2 years
March 11, 2011
June 27, 2012
Conditions
Outcome Measures
Primary Outcomes (4)
Induction therapy failure
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
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
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
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 Outcomes (3)
Pathologic response
6 weeks after completion of chemoradiation therapy (CRT)
Progression-free survival
Every 3 months for 2 years and every 6 months thereafter
Overall survival
Every 3 months for 2 years and every 6 months thereafter
Study Arms (3)
Group A (FDG PET/CT between RT fractions 5-6)
EXPERIMENTALPatients 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.
Group B (FDG PET/CT between RT fractions 10-11)
EXPERIMENTALPatients 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.
Group C (FDG PET/CT between RT fractions 15-16)
EXPERIMENTALPatients 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
Undergo FDG PET/CT
Undergo FDG PET/CT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Khanh Nguyen
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2011
First Posted
March 14, 2011
Study Start
April 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
June 29, 2012
Record last verified: 2012-06