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Study was closed and reopened as NCT01717391
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| Name | Class |
|---|---|
| Holden Comprehensive Cancer Center | OTHER |
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Our primary hypothesis is that [18F]FLT PET can identify active bone marrow in addition to metabolically active tumor.
This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. The radiation plan is then designed to spare that area, in hopes of keeping the bone marrow active during therapy. Bone marrow and tumor activity will be monitored using a sequence of FLT PET scans during the course of chemotherapy and radiation therapy.
Subjects will undergo a total of up to 5 FLT PET scans.
Subjects are randomized between two groups to reduce radiation exposure from the FLT PET scans. If bone marrow activity is not identified in one scan, further scans are cancelled until the 1-month follow up scan. This is not a randomization to compare therapeutic efficacy between two study arms. Data will be pooled for analysis as pre-specified in the study's statistical plan.
Group 1 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 15 radiation treatments, and then 1 month after completing radiation therapy.
Group 2 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 20 radiation treatments, and then 1 month after completing radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 2 | Experimental | Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy. |
|
| Group 1 | Experimental | Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [F18]Fluorothymidine | Drug | FLT PET scan 5 mCi (+/- 10%) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Difference From Baseline IMRT Plan (%) | 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. | Baseline (pre-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy Compliance | The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts. | post-treatment |
| Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael M Graham, Ph.D., M.D. | University of Iowa | Study Director |
| Sarah McGuire, Ph.D. | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21397965 | Background | McGuire SM, Menda Y, Ponto LL, Gross B, Juweid M, Bayouth JE. A methodology for incorporating functional bone marrow sparing in IMRT planning for pelvic radiation therapy. Radiother Oncol. 2011 Apr;99(1):49-54. doi: 10.1016/j.radonc.2011.01.025. Epub 2011 Mar 22. | |
| 21300484 | Background | McGuire SM, Menda Y, Boles Ponto LL, Gross B, Buatti J, Bayouth JE. 3'-deoxy-3'-[(1)(8)F]fluorothymidine PET quantification of bone marrow response to radiation dose. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):888-93. doi: 10.1016/j.ijrobp.2010.12.009. Epub 2011 Feb 6. |
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Yes, data will be shared utilizing clinicaltrials.gov results
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| ID | Title | Description |
|---|---|---|
| FG000 | 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%) |
| FG001 | 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%) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy. [F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%) |
| BG001 | Group 2 | Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy. [F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Difference From Baseline IMRT Plan (%) | 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. | 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). | Posted | Mean | Standard Deviation | Percent difference (%) | Baseline (pre-treatment) |
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Adverse events were collected from the time of FLT injection through 24 hours post-injection.
The medical chart was reviewed for possible adverse events post-FLT administration; this is considered non-systematic. The participant was contacted by a licensed healthcare provider to assess for adverse events - this was a systematic approach.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy. [F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%) |
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The results of this pilot study were merged with NCT01717391 for analysis and resultant publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah McGuire, PhD | The University of Iowa | 214-645-7613 | Sarah.McGuire@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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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
| baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment |
| Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 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 | baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment |
| Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 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. | baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment |
| Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 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 | baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment |
| 20447554 | Background | Menda Y, Ponto LL, Dornfeld KJ, Tewson TJ, Watkins GL, Gupta AK, Anderson C, McGuire S, Schultz MK, Sunderland JJ, Graham MM, Buatti JM. Investigation of the pharmacokinetics of 3'-deoxy-3'-[18F]fluorothymidine uptake in the bone marrow before and early after initiation of chemoradiation therapy in head and neck cancer. Nucl Med Biol. 2010 May;37(4):433-8. doi: 10.1016/j.nucmedbio.2010.02.005. |
| 27319286 | Result | McGuire SM, Bhatia SK, Sun W, Jacobson GM, Menda Y, Ponto LL, Smith BJ, Gross BA, Bayouth JE, Sunderland JJ, Graham MM, Buatti JM. Using [(18)F]Fluorothymidine Imaged With Positron Emission Tomography to Quantify and Reduce Hematologic Toxicity Due to Chemoradiation Therapy for Pelvic Cancer Patients. Int J Radiat Oncol Biol Phys. 2016 Sep 1;96(1):228-39. doi: 10.1016/j.ijrobp.2016.04.009. Epub 2016 Apr 19. |
| 25207403 | Result | McGuire SM, Menda Y, Ponto LLB, Gross B, TenNapel M, Smith BJ, Bayouth JE. Spatial mapping of functional pelvic bone marrow using FLT PET. J Appl Clin Med Phys. 2014 Jul 8;15(4):129-136. doi: 10.1120/jacmp.v15i4.4780. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | All Participants | The outcome measure is evaluated by including study participants from both groups. |
|
|
| Secondary | Chemotherapy Compliance | The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts. | 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). | Posted | Count of Participants | Participants | post-treatment |
|
|
|
| Secondary | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 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 | 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). | Posted | Count of Participants | Participants | baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment |
|
|
|
| Secondary | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 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 | 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). | Posted | Count of Participants | Participants | baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment |
|
|
|
| Secondary | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 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. | 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). | Posted | Count of Participants | Participants | baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment |
|
|
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| Secondary | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 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 | 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). | Posted | Count of Participants | Participants | baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Group 2 | Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy. [F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%) | 0 | 2 | 0 | 2 | 0 | 2 |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| CTCAE grade 3 |
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| CTCAE grade 4 (most severe) |
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| Not assessed (test omitted) |
|
| Therapy, week 1 |
|
| Therapy, week 2 |
|
| Therapy, week 3 |
|
| Therapy, week 4 |
|
| Therapy, week 5 |
|
| 30 days post-therapy |
|
| CTCAE grade 3 |
|
| CTCAE grade 4 (most severe) |
|
| Not assessed (test omitted) |
|
| Therapy, week 1 |
|
| Therapy, week 2 |
|
| Therapy, week 3 |
|
| Therapy, week 4 |
|
| Therapy, week 5 |
|
| 30 days post-therapy |
|
| CTCAE grade 3 |
|
| CTCAE grade 4 (most severe) |
|
| Not assessed (test omitted) |
|
| Therapy, week 1 |
|
| Therapy, week 2 |
|
| Therapy, week 3 |
|
| Therapy, week 4 |
|
| Therapy, week 5 |
|
| 30 days post-therapy |
|
| CTCAE grade 3 |
|
| CTCAE grade 4 (most severe) |
|
| Not assessed (test omitted) |
|
| Therapy, week 1 |
|
| Therapy, week 2 |
|
| Therapy, week 3 |
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| Therapy, week 4 |
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| Therapy, week 5 |
|
| 30 days post-therapy |
|