Trial Outcomes & Findings for A Comparison of FLT to FDG PET/CT in the Early Assessment of Chemotherapy Response in Stage IB-IIIA Resectable NSCLC (NCT NCT00963807)
NCT ID: NCT00963807
Last Updated: 2017-03-17
Results Overview
Will be calculated by subtracting the uptake of the scan after the first cycle of chemotherapy from the uptake of the pre-treatment scan.. Change in FLT uptake will be measured using the maximum standard uptake value adjusted for lean body mass (SULmax), which is a measure of how much radiotracer (in this case FLT) is being consumed by cells.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Baseline and 3 weeks
Results posted on
2017-03-17
Participant Flow
Participant milestones
| Measure |
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)
Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
Completed Baseline Imaging
|
11
|
|
Overall Study
Completed Post-Cycle 1 Imaging
|
9
|
|
Overall Study
Completed Post-Cycle 2 FLT Imaging
|
9
|
|
Overall Study
Completed Post-Cycle 2 FDG Imaging
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)
Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Reaction to study chemotherapy regimen
|
1
|
|
Overall Study
Disease progression
|
15
|
Baseline Characteristics
A Comparison of FLT to FDG PET/CT in the Early Assessment of Chemotherapy Response in Stage IB-IIIA Resectable NSCLC
Baseline characteristics by cohort
| Measure |
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)
n=11 Participants
Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|
|
Age, Continuous
|
56.4 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 weeksWill be calculated by subtracting the uptake of the scan after the first cycle of chemotherapy from the uptake of the pre-treatment scan.. Change in FLT uptake will be measured using the maximum standard uptake value adjusted for lean body mass (SULmax), which is a measure of how much radiotracer (in this case FLT) is being consumed by cells.
Outcome measures
| Measure |
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)
n=9 Participants
Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery
|
Non-Responders
RECIST non-responders based on CT measurements performed after 2 cycles of neoadjuvant therapy
|
|---|---|---|
|
Change in 18F-Fluorothymidine (FLT) Uptake
|
-0.4 SULmax
Standard Deviation 1.9
|
—
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksWill be calculated by subtracting the uptake of the scan after the second cycle of chemotherapy from the uptake of the pre-treatment scan.
Outcome measures
| Measure |
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)
n=9 Participants
Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery
|
Non-Responders
RECIST non-responders based on CT measurements performed after 2 cycles of neoadjuvant therapy
|
|---|---|---|
|
Change in FLT Uptake
|
0.2 SULmax
Standard Deviation 3.8
|
—
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksUnadjusted analysis will be performed utilizing students t-tests. If the data appears non-normal, the Wilcox on rank-sum test will be used rather than the t-test. Adjusted analysis will be performed utilizing logistic regression.
Outcome measures
| Measure |
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)
n=3 Participants
Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery
|
Non-Responders
n=6 Participants
RECIST non-responders based on CT measurements performed after 2 cycles of neoadjuvant therapy
|
|---|---|---|
|
Change in FLT Uptake in Responders and Non-responders
|
-1.8 SULmax
Standard Deviation 2.1
|
1.2 SULmax
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksWill be calculated by subtracting the baseline FDG uptake from the post-cycle 2 uptake (as measured by SULmax).
Outcome measures
| Measure |
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)
n=8 Participants
Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery
|
Non-Responders
RECIST non-responders based on CT measurements performed after 2 cycles of neoadjuvant therapy
|
|---|---|---|
|
Change in 18F-Fluorodeoxyglucose (FDG) Uptake
|
-3.8 SULmax
Standard Deviation 3.9
|
—
|
SECONDARY outcome
Timeframe: Up to 6 weeksRECIST version 1.1 was utilized for this outcome measure. A detailed description of RECIST 1.1 can be found here: Nishino M, Jackman DM, Hatabu H, Yeap BY, Cioffredi LA, Yap JT, et al. New Response Evaluation Criteria in Solid Tumors (RECIST) guidelines for advanced non-small cell lung cancer: comparison with original RECIST and impact on assessment of tumor response to targeted therapy. AJR Am J Roentgenol 2010;195:W221-8.
Outcome measures
| Measure |
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)
n=9 Participants
Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery
|
Non-Responders
RECIST non-responders based on CT measurements performed after 2 cycles of neoadjuvant therapy
|
|---|---|---|
|
Overall Response Rate Reported as a Proportion of the Total Number of Patients Who Received at Least One Cycle of Therapy Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)
|
33 percentage of participants
|
—
|
Adverse Events
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)
n=9 participants at risk
Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Death
|
11.1%
1/9
|
|
Immune system disorders
Neutropenic Fever
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 3
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60