Trial Outcomes & Findings for [F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers (NCT NCT01717391)
NCT ID: NCT01717391
Last Updated: 2019-03-26
Results Overview
The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation doses evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Baseline (pre-treatment)
Results posted on
2019-03-26
Participant Flow
Participant milestones
| Measure |
FLT PET/CT
FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.
Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
FLT PET/CT
FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.
Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
FLT technical failure
|
3
|
Baseline Characteristics
[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers
Baseline characteristics by cohort
| Measure |
FLT PET/CT
n=36 Participants
FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.
Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-treatment)Population: All participants who received an FLT PET/CT during radiation simulation.
The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation doses evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan.
Outcome measures
| Measure |
Basline FLT PET/CT (All Subjects)
n=27 Participants
FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
|
|---|---|
|
Percent Difference From Baseline IMRT Plan (%)
% difference, volume receiving 5 Gray
|
-4.7 Percent difference (%)
Standard Deviation 3.3
|
|
Percent Difference From Baseline IMRT Plan (%)
% difference, volume receiving 10 Gray
|
-9.3 Percent difference (%)
Standard Deviation 4.2
|
|
Percent Difference From Baseline IMRT Plan (%)
% difference, volume receiving 20 Gray
|
-14.2 Percent difference (%)
Standard Deviation 4.1
|
|
Percent Difference From Baseline IMRT Plan (%)
% difference, volume receiving 30 Gray
|
-13.4 Percent difference (%)
Standard Deviation 7.6
|
|
Percent Difference From Baseline IMRT Plan (%)
% difference, dose to target (tumor) volume
|
-0.1 Percent difference (%)
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: At 24 monthsThe number of participants who had chemotherapy withheld at least once for low blood counts.
Outcome measures
| Measure |
Basline FLT PET/CT (All Subjects)
n=27 Participants
FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
|
|---|---|
|
Chemotherapy Compliance
|
7 Participants
|
SECONDARY outcome
Timeframe: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatmentPopulation: This group includes all tumor types treated in this clinical trial and provides an overall averages.
White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up
Outcome measures
| Measure |
Basline FLT PET/CT (All Subjects)
n=27 Participants
FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
|
|---|---|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
1 year post-therapy · Not assessed (test omitted)
|
9 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Baseline (pre-treatment) · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Baseline (pre-treatment) · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Baseline (pre-treatment) · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 1 · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 1 · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 1 · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 1 · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 2 · Grade 0 (no toxicity)
|
15 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 2 · CTCAE grade 1
|
7 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 2 · CTCAE grade 2
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 2 · CTCAE grade 3
|
3 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 2 · CTCAE grade 4 (most severe)
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 2 · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 3 · Grade 0 (no toxicity)
|
13 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 3 · CTCAE grade 1
|
5 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 3 · CTCAE grade 3
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 3 · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 3 · Not assessed (test omitted)
|
6 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 4 · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 4 · Not assessed (test omitted)
|
3 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 5 · CTCAE grade 3
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 5 · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 5 · Not assessed (test omitted)
|
10 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
30 days post-therapy · Grade 0 (no toxicity)
|
20 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
30 days post-therapy · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
30 days post-therapy · Not assessed (test omitted)
|
5 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
1 year post-therapy · Grade 0 (no toxicity)
|
16 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
1 year post-therapy · CTCAE grade 1
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
1 year post-therapy · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Baseline (pre-treatment) · Grade 0 (no toxicity)
|
27 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Baseline (pre-treatment) · CTCAE grade 1
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Baseline (pre-treatment) · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 1 · Grade 0 (no toxicity)
|
27 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 1 · CTCAE grade 1
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 3 · CTCAE grade 2
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 4 · Grade 0 (no toxicity)
|
13 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 4 · CTCAE grade 1
|
5 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 4 · CTCAE grade 2
|
4 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 4 · CTCAE grade 3
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 5 · Grade 0 (no toxicity)
|
10 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 5 · CTCAE grade 1
|
3 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 5 · CTCAE grade 2
|
3 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
30 days post-therapy · CTCAE grade 1
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
30 days post-therapy · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
30 days post-therapy · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
1 year post-therapy · CTCAE grade 2
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
1 year post-therapy · CTCAE grade 3
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatmentPopulation: This group includes all tumor types treated in this clinical trial and provides an overall averages.
Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
Outcome measures
| Measure |
Basline FLT PET/CT (All Subjects)
n=27 Participants
FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
|
|---|---|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Baseline (pre-treatment) · CTCAE grade 0 (no toxicity)
|
27 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Baseline (pre-treatment) · CTCAE grade 1
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Baseline (pre-treatment) · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Baseline (pre-treatment) · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 1 · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 1 · CTCAE grade 4 (severe toxicity)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 1 · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 2 · CTCAE grade 0 (no toxicity)
|
16 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 2 · CTCAE grade 1
|
9 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 3 · CTCAE grade 0 (no toxicity)
|
12 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 3 · CTCAE grade 1
|
6 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 3 · CTCAE grade 3
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 3 · CTCAE grade 4 (severe toxicity)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 3 · Not assessed (test omitted)
|
7 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 4 · CTCAE grade 0 (no toxicity)
|
15 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 4 · CTCAE grade 1
|
6 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 4 · CTCAE grade 2
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 4 · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 4 · CTCAE grade 4 (severe toxicity)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 4 · Not assessed (test omitted)
|
4 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
30 days post-therapy · CTCAE grade 2
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
30 days post-therapy · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
30 days post-therapy · CTCAE grade 4 (severe toxicity)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
30 days post-therapy · Not assessed (test omitted)
|
5 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
1 year post-therapy · Not assessed (test omitted)
|
9 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Baseline (pre-treatment) · CTCAE grade 4 (severe toxicity)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Baseline (pre-treatment) · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 1 · CTCAE grade 0 (no toxicity)
|
27 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 1 · CTCAE grade 1
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 1 · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 2 · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 2 · CTCAE grade 3
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 2 · CTCAE grade 4 (severe toxicity)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 2 · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 3 · CTCAE grade 2
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 5 · CTCAE grade 0 (no toxicity)
|
9 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 5 · CTCAE grade 1
|
7 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 5 · CTCAE grade 2
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 5 · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 5 · CTCAE grade 4 (severe toxicity)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 5 · Not assessed (test omitted)
|
10 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
30 days post-therapy · CTCAE grade 0 (no toxicity)
|
17 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
30 days post-therapy · CTCAE grade 1
|
4 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
1 year post-therapy · CTCAE grade 0 (no toxicity)
|
16 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
1 year post-therapy · CTCAE grade 1
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
1 year post-therapy · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
1 year post-therapy · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
1 year post-therapy · CTCAE grade 4 (severe toxicity)
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatmentPopulation: This group includes all tumor types treated in this clinical trial and provides an overall averages.
Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
Outcome measures
| Measure |
Basline FLT PET/CT (All Subjects)
n=27 Participants
FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
|
|---|---|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Baseline (pre-treatment) · CTCAE grade 0 (no toxicity)
|
27 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Baseline (pre-treatment) · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 1 · CTCAE grade 0 (no toxicity)
|
25 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 1 · CTCAE grade 1
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 1 · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 3 · Not assessed (test omitted)
|
6 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 4 · CTCAE grade 0 (no toxicity)
|
17 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 4 · Not assessed (test omitted)
|
3 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 5 · CTCAE grade 0 (no toxicity)
|
13 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 5 · CTCAE grade 1
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 5 · CTCAE grade 2
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
30 days post-therapy · CTCAE grade 0 (no toxicity)
|
21 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
30 days post-therapy · CTCAE grade 1
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
30 days post-therapy · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
30 days post-therapy · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
30 days post-therapy · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Baseline (pre-treatment) · CTCAE grade 1
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Baseline (pre-treatment) · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Baseline (pre-treatment) · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Baseline (pre-treatment) · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 1 · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 1 · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 1 · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 2 · CTCAE grade 0 (no toxicity)
|
16 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 2 · CTCAE grade 1
|
8 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 2 · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 2 · CTCAE grade 3
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 2 · CTCAE grade 4 (most severe)
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 2 · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 3 · CTCAE grade 0 (no toxicity)
|
16 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 3 · CTCAE grade 1
|
4 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 3 · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 3 · CTCAE grade 3
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 3 · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 4 · CTCAE grade 1
|
5 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 4 · CTCAE grade 2
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 4 · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 4 · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 5 · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 5 · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 5 · Not assessed (test omitted)
|
10 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
30 days post-therapy · Not assessed (test omitted)
|
5 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
1 year post-therapy · CTCAE grade 0 (no toxicity)
|
16 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
1 year post-therapy · CTCAE grade 1
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
1 year post-therapy · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
1 year post-therapy · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
1 year post-therapy · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
1 year post-therapy · Not assessed (test omitted)
|
9 Participants
|
SECONDARY outcome
Timeframe: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatmentPopulation: This group includes all tumor types treated in this clinical trial and provides an overall averages.
Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
Outcome measures
| Measure |
Basline FLT PET/CT (All Subjects)
n=27 Participants
FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
|
|---|---|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 4 · CTCAE grade 2
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 4 · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 5 · CTCAE grade 1
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 5 · CTCAE grade 2
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 5 · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
30 days post-therapy · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
30 days post-therapy · Not assessed (test omitted)
|
5 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
1 year post-therapy · CTCAE grade 0 (no toxicity)
|
16 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
1 year post-therapy · CTCAE grade 1
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Baseline (pre-treatment) · CTCAE grade 0 (no toxicity)
|
27 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Baseline (pre-treatment) · CTCAE grade 1
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Baseline (pre-treatment) · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Baseline (pre-treatment) · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Baseline (pre-treatment) · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Baseline (pre-treatment) · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 1 · CTCAE grade 0 (no toxicity)
|
25 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 1 · CTCAE grade 1
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 1 · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 1 · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 1 · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 1 · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 2 · CTCAE grade 0 (no toxicity)
|
16 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 2 · CTCAE grade 1
|
8 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 2 · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 2 · CTCAE grade 3
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 2 · CTCAE grade 4 (most severe)
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 2 · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 3 · CTCAE grade 0 (no toxicity)
|
16 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 3 · CTCAE grade 1
|
4 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 3 · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 3 · CTCAE grade 3
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 3 · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 3 · Not assessed (test omitted)
|
6 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 4 · CTCAE grade 0 (no toxicity)
|
17 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 4 · CTCAE grade 1
|
5 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 4 · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 4 · Not assessed (test omitted)
|
3 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 5 · CTCAE grade 0 (no toxicity)
|
13 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 5 · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 5 · Not assessed (test omitted)
|
10 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
30 days post-therapy · CTCAE grade 0 (no toxicity)
|
21 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
30 days post-therapy · CTCAE grade 1
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
30 days post-therapy · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
30 days post-therapy · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
1 year post-therapy · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
1 year post-therapy · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
1 year post-therapy · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
1 year post-therapy · Not assessed (test omitted)
|
9 Participants
|
Adverse Events
FLT PET/CT
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FLT PET/CT
n=27 participants at risk
FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.
Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea, grade 1
|
11.1%
3/27 • Number of events 5 • Adverse events were collected for 48 hours after injection with FLT, the investigational drug under study.
Adverse events were collected through medical chart review as well as by direct contact by a licensed health provider with participant for their perceived side effects from the FLT PET/CT scan. Chart review is considered non-systematic collection; the semi-structured interview 48 hours after the scan is considered a systematic collection. Grade 0 is considered no toxicity (symptom is absent) and grade 4 is considered the most severe toxicity.
|
|
Gastrointestinal disorders
Diarrhea, grade 2
|
7.4%
2/27 • Number of events 2 • Adverse events were collected for 48 hours after injection with FLT, the investigational drug under study.
Adverse events were collected through medical chart review as well as by direct contact by a licensed health provider with participant for their perceived side effects from the FLT PET/CT scan. Chart review is considered non-systematic collection; the semi-structured interview 48 hours after the scan is considered a systematic collection. Grade 0 is considered no toxicity (symptom is absent) and grade 4 is considered the most severe toxicity.
|
|
Gastrointestinal disorders
Nausea, grade 1
|
22.2%
6/27 • Number of events 6 • Adverse events were collected for 48 hours after injection with FLT, the investigational drug under study.
Adverse events were collected through medical chart review as well as by direct contact by a licensed health provider with participant for their perceived side effects from the FLT PET/CT scan. Chart review is considered non-systematic collection; the semi-structured interview 48 hours after the scan is considered a systematic collection. Grade 0 is considered no toxicity (symptom is absent) and grade 4 is considered the most severe toxicity.
|
|
Nervous system disorders
Headache, grade 1
|
7.4%
2/27 • Number of events 2 • Adverse events were collected for 48 hours after injection with FLT, the investigational drug under study.
Adverse events were collected through medical chart review as well as by direct contact by a licensed health provider with participant for their perceived side effects from the FLT PET/CT scan. Chart review is considered non-systematic collection; the semi-structured interview 48 hours after the scan is considered a systematic collection. Grade 0 is considered no toxicity (symptom is absent) and grade 4 is considered the most severe toxicity.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place