Trial Outcomes & Findings for FLT PET Imaging for Cervical Cancer (NCT NCT01075412)
NCT ID: NCT01075412
Last Updated: 2017-12-02
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 dose bins 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
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Baseline (pre-treatment)
Results posted on
2017-12-02
Participant Flow
Participant milestones
| Measure |
Group 1
Scheduled to receive the fourth \[F18\]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy. If no bone marrow uptake is seen at the second or third FLT PET scan, this scan is omitted to reduce radiation risk.
\[F18\]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)
|
Group 2
Receives fourth \[F18\]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy. If no bone marrow uptake is seen at the second or third FLT PET scan, this scan is omitted to reduce radiation risk.
\[F18\]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group 1
Scheduled to receive the fourth \[F18\]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy. If no bone marrow uptake is seen at the second or third FLT PET scan, this scan is omitted to reduce radiation risk.
\[F18\]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)
|
Group 2
Receives fourth \[F18\]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy. If no bone marrow uptake is seen at the second or third FLT PET scan, this scan is omitted to reduce radiation risk.
\[F18\]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
FLT PET Imaging for Cervical Cancer
Baseline characteristics by cohort
| Measure |
Group 1
n=4 Participants
Receives fourth \[F18\]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.
\[F18\]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)
|
Group 2
n=2 Participants
Receives fourth \[F18\]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.
\[F18\]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
2 participants
n=4 Participants
|
6 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-treatment)Population: Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).
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 dose bins 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 |
All Participants
n=5 Participants
The outcome measure is evaluated by including study participants from both groups.
|
|---|---|
|
Percent Difference From Baseline IMRT Plan (%)
% difference, volume receiving 5 Gray
|
-8.5 Percent difference (%)
Standard Deviation 6.0
|
|
Percent Difference From Baseline IMRT Plan (%)
% difference, volume receiving 10 Gray
|
-11.7 Percent difference (%)
Standard Deviation 7.3
|
|
Percent Difference From Baseline IMRT Plan (%)
% difference, volume receiving 20 Gray
|
-15.8 Percent difference (%)
Standard Deviation 3.8
|
|
Percent Difference From Baseline IMRT Plan (%)
% difference, volume receiving 30 Gray
|
-16.5 Percent difference (%)
Standard Deviation 12.6
|
|
Percent Difference From Baseline IMRT Plan (%)
% difference, dose to target (tumor) volume
|
-0.2 Percent difference (%)
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: post-treatmentPopulation: Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).
The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts.
Outcome measures
| Measure |
All Participants
n=5 Participants
The outcome measure is evaluated by including study participants from both groups.
|
|---|---|
|
Chemotherapy Compliance
Received all chemotherapy as precscribed
|
4 Participants
|
|
Chemotherapy Compliance
Missed 1 cycle of chemotherapy
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatmentPopulation: Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).
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 |
All Participants
n=5 Participants
The outcome measure is evaluated by including study participants from both groups.
|
|---|---|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Baseline (pre-treatment) · CTCAE grade 0 (no toxicity)
|
5 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
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 0 (no toxicity)
|
5 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 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 · CTCAE grade 0 (no toxicity)
|
4 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 2 · CTCAE grade 1
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 2 · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 2 · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 2 · CTCAE grade 4 (most severe)
|
0 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 · CTCAE grade 0 (no toxicity)
|
3 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 3 · 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 3 · CTCAE grade 3
|
0 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)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 4 · CTCAE grade 0 (no toxicity)
|
3 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 4 · CTCAE grade 1
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 4 · CTCAE grade 2
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 4 · CTCAE grade 3
|
0 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)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 5 · CTCAE grade 0 (no toxicity)
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 5 · CTCAE grade 1
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 5 · CTCAE grade 2
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Therapy, week 5 · CTCAE grade 3
|
0 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)
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
30 days post-therapy · CTCAE grade 0 (no toxicity)
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
30 days post-therapy · CTCAE grade 1
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
30 days post-therapy · CTCAE grade 2
|
1 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
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)
|
3 Participants
|
SECONDARY outcome
Timeframe: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatmentPopulation: Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).
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 |
All Participants
n=5 Participants
The outcome measure is evaluated by including study participants from both groups.
|
|---|---|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 5 · CTCAE grade 0 (no toxicity)
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Baseline (pre-treatment) · CTCAE grade 0 (no toxicity)
|
5 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.
Baseline (pre-treatment) · CTCAE grade 4 (most severe)
|
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)
|
5 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 1 · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 1 · CTCAE grade 4 (most severe)
|
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)
|
4 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 2 · CTCAE grade 1
|
1 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
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 2 · CTCAE grade 4 (most severe)
|
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 0 (no toxicity)
|
3 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 3 · CTCAE grade 1
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 3 · CTCAE grade 2
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 3 · CTCAE grade 3
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 3 · CTCAE grade 4 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 3 · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 4 · CTCAE grade 0 (no toxicity)
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 4 · CTCAE grade 1
|
3 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 4 · CTCAE grade 2
|
0 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 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 4 · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 5 · CTCAE grade 1
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 5 · CTCAE grade 2
|
0 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 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Therapy, week 5 · Not assessed (test omitted)
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
30 days post-therapy · CTCAE grade 0 (no toxicity)
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
30 days post-therapy · CTCAE grade 1
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
30 days post-therapy · CTCAE grade 2
|
0 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 (most severe)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
30 days post-therapy · Not assessed (test omitted)
|
3 Participants
|
SECONDARY outcome
Timeframe: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatmentPopulation: Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).
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 |
All Participants
n=5 Participants
The outcome measure is evaluated by including study participants from both groups.
|
|---|---|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Baseline (pre-treatment) · CTCAE grade 0 (no toxicity)
|
5 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)
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)
|
5 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 1 · CTCAE grade 1
|
0 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 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)
|
5 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 2 · CTCAE grade 1
|
0 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
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 2 · CTCAE grade 4 (most severe)
|
0 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)
|
3 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 3 · CTCAE grade 1
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 3 · CTCAE grade 2
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 3 · CTCAE grade 3
|
0 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 3 · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 4 · CTCAE grade 0 (no toxicity)
|
3 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 4 · CTCAE grade 1
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 4 · CTCAE grade 2
|
1 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 4 · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 5 · CTCAE grade 0 (no toxicity)
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 5 · CTCAE grade 1
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Therapy, week 5 · CTCAE grade 2
|
1 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)
|
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)
|
1 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)
30 days post-therapy · Not assessed (test omitted)
|
3 Participants
|
SECONDARY outcome
Timeframe: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatmentPopulation: Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).
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 |
All Participants
n=5 Participants
The outcome measure is evaluated by including study participants from both groups.
|
|---|---|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Baseline (pre-treatment) · CTCAE grade 0 (no toxicity)
|
5 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)
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 1 · CTCAE grade 1
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 1 · CTCAE grade 2
|
2 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)
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 2 · CTCAE grade 1
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 2 · CTCAE grade 2
|
1 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)
|
1 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)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 3 · CTCAE grade 1
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 3 · CTCAE grade 2
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 3 · CTCAE grade 3
|
4 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)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 4 · CTCAE grade 0 (no toxicity)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 4 · CTCAE grade 1
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 4 · CTCAE grade 2
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 4 · CTCAE grade 3
|
3 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 4 · CTCAE grade 4 (most severe)
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 4 · Not assessed (test omitted)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 5 · CTCAE grade 0 (no toxicity)
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Therapy, week 5 · CTCAE grade 1
|
0 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
|
1 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)
|
2 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
30 days post-therapy · CTCAE grade 0 (no toxicity)
|
1 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
30 days post-therapy · CTCAE grade 1
|
0 Participants
|
|
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
30 days post-therapy · CTCAE grade 2
|
1 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.
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)
|
3 Participants
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place