Uterine Cervical NeoplasmsPhase 2NCT01717391
[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers
A Phase 2 study testing fluorothymidine F 18 in people with Uterine Cervical Neoplasms and Endometrial Neoplasms, run by John M. Buatti at 1 site in United States.
Trial summary
[F-18] Fluorothymidine PET imaging will be used to create a radiation therapy treatment plan to avoid active bone marrow in the pelvis. This will be done to evaluate if sparing bone marrow will help maintain blood counts. This would impact chemotherapy administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Anus Neoplasms
- What is being tested?
- fluorothymidine F 18
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2012to 30 Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to sign a written informed consent document.
- Recommended to undergo pelvic irradiation with concurrent chemotherapy.
- At least 18 years of age. Pediatrics would be best served by a protocol designed for their specific needs.
- Karnofsky Performance Status of at least 60% at time of screening.
- Life expectancy of greater than 6 months.
- Subject must have normal organ and marrow function (as defined below) within 30 days of study enrollment:
Show all 11Show fewer
- leukocytes at least 3,000 / µL
- absolute neutrophil count of at least 1500 / µL
- platelets of at least 100,000 / µL
- creatinine equal to or less than the upper limit of normal
- not pregnant (as applicable)
Who cannot join
- history of allergic reactions attributed to compounds of similar chemical or biologic composition to FLT
- an oncology research protocol requiring full pelvic radiation (i.e., 4 field box technique)
- uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- subjects taking nucleoside analog medications such as those used as antiretroviral agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
About this study
Official title: Improving Pelvic Cancer Patient Chemoradiotherapy Outcomes With FLT PET Imaging
[F-18] Fluorothymidine PET imaging will be used to create a radiation therapy treatment plan to avoid active bone marrow in the pelvis. This will be done to evaluate if sparing bone marrow will help maintain blood counts. This would impact chemotherapy administration.
Read the detailed description
Overall survival of pelvic cancer patients depends on control of systemic disease. If local radiation therapy depletes bone marrow function to such an extent that systemic therapies must be withheld, chances of metastatic failure increase significantly. This may be more significant for this group of patients because approximately one third of adult bone marrow is located in the pelvic region. Strategies to minimize toxicities would benefit a range of pelvic cancer patients including gynecologic, anal, rectal, and prostate. New chemoradiation combinations improve outcomes for these disease sites, but come at the cost of higher levels of toxicity. As many as 40% of cervical cancer patients miss at least one chemotherapy cycle due to hematologic toxicity and 36% of anal cancer patients experience grade 3 or 4 hematologic toxicity when undergoing chemoradiation therapy. A clinical trial of concurrent chemoradiation therapy for rectal cancer was terminated due to toxicity, including hematologic toxicities. Concurrent chemoradiation therapy shows promise for advanced stage prostate cancers, but it also increases grade 3 and 4 toxicities. To successfully limit hematologic toxicities for pelvic cancers, it is extremely advantageous to avoid irradiating the highly proliferative compartments of the pelvic bone marrow. However, the complex structure of the pelvis makes it difficult to assess the efficacy of radiation therapy (RT) planning strategies to avoid areas critical to hematopoiesis. Uptake of [18F]fluorothymidine imaged with positron emission tomography (FLT PET/CT) can be an accurate and sensitive tool for identifying and monitoring the effects of chemoradiation on proliferative pelvic bone marrow. Clinically validating the utility of FLT PET/CT imaging for identifying active bone marrow in the design of bone marrow sparing RT-plans and the important bone marrow assessment time points would provide a method to reduce acute and chronic hematologic toxicities for pelvic cancer patients.
- Conditions
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Anus Neoplasms, Rectal Neoplasms, Prostatic Neoplasms
- Being tested
- fluorothymidine F 18
- Keywords
- radiotherapy, Positron-Emission Tomography and Computed Tomography, chemotherapy, bone marrow
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Anus Neoplasms, Rectal Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorothymidine F 18Drug
Also called [F-18] Fluorothymidine
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.
| Study group | Role | What they receive |
|---|---|---|
| Fluorothymidine F 18 PET/CT | Experimental | Fluorothymidine F 18 (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. Receives: Drug: fluorothymidine F 18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: Baseline (pre-treatment)
Secondary outcomes (5)
Chemotherapy Compliance
The number of participants who had chemotherapy withheld at least once for low blood counts.
Measured: At 24 months
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
Measured: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after 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
Measured: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after 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
Measured: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after 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
Measured: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study start1 Oct 2012
- Primary completion29 Feb 2016
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- John M. Buatti
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, John M. Buatti, University of Iowa
- Investigators
- John Buatti, PhD, Principal investigator, Department of Radiation Oncology, The University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717391
- Sponsor's protocol ID
- 201204712
- Other IDs
- R01CA169336
- Status last verified
- Mar 2019
- First submitted
- 18 Oct 2012
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon request. A contract may need to be put into place, dependent upon data shared.
Publications
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.
PubMed 21397965McGuire 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.
PubMed 21300484Menda 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.
PubMed 20447554McGuire 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.
PubMed 27319286McGuire 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.
PubMed 25207403
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pelvic Cancer Patient Chemoradiotherapy Outcomes With FLT PET Imaging
- ClinicalTrials.gov ID
- NCT01717391
- Acronym / sponsor ID
- 201204712
- Conditions
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Anus Neoplasms, Rectal Neoplasms, Prostatic Neoplasms
- Keywords
- radiotherapy, Positron-Emission Tomography and Computed Tomography, chemotherapy, bone marrow
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- John M. BuattiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 1 Oct 2012
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Posted 5 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
[F-18] Fluorothymidine PET imaging will be used to create a radiation therapy treatment plan to avoid active bone marrow in the pelvis. This will be done to evaluate if sparing bone marrow will help maintain blood counts. This would impact chemotherapy administration.
Detailed description
Overall survival of pelvic cancer patients depends on control of systemic disease. If local radiation therapy depletes bone marrow function to such an extent that systemic therapies must be withheld, chances of metastatic failure increase significantly. This may be more significant for this group of patients because approximately one third of adult bone marrow is located in the pelvic region. Strategies to minimize toxicities would benefit a range of pelvic cancer patients including gynecologic, anal, rectal, and prostate. New chemoradiation combinations improve outcomes for these disease sites, but come at the cost of higher levels of toxicity. As many as 40% of cervical cancer patients miss at least one chemotherapy cycle due to hematologic toxicity and 36% of anal cancer patients experience grade 3 or 4 hematologic toxicity when undergoing chemoradiation therapy. A clinical trial of concurrent chemoradiation therapy for rectal cancer was terminated due to toxicity, including hematologic toxicities. Concurrent chemoradiation therapy shows promise for advanced stage prostate cancers, but it also increases grade 3 and 4 toxicities. To successfully limit hematologic toxicities for pelvic cancers, it is extremely advantageous to avoid irradiating the highly proliferative compartments of the pelvic bone marrow. However, the complex structure of the pelvis makes it difficult to assess the efficacy of radiation therapy (RT) planning strategies to avoid areas critical to hematopoiesis. Uptake of [18F]fluorothymidine imaged with positron emission tomography (FLT PET/CT) can be an accurate and sensitive tool for identifying and monitoring the effects of chemoradiation on proliferative pelvic bone marrow. Clinically validating the utility of FLT PET/CT imaging for identifying active bone marrow in the design of bone marrow sparing RT-plans and the important bone marrow assessment time points would provide a method to reduce acute and chronic hematologic toxicities for pelvic cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorothymidine F 18 PET/CT | Experimental | Drug: fluorothymidine F 18Fluorothymidine F 18 (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to understand and willingness to sign a written informed consent document.
- Recommended to undergo pelvic irradiation with concurrent chemotherapy.
- At least 18 years of age. Pediatrics would be best served by a protocol designed for their specific needs.
- Karnofsky Performance Status of at least 60% at time of screening.
- Life expectancy of greater than 6 months.
Key exclusion criteria (4 listed)
- history of allergic reactions attributed to compounds of similar chemical or biologic composition to FLT
- an oncology research protocol requiring full pelvic radiation (i.e., 4 field box technique)
- uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- subjects taking nucleoside analog medications such as those used as antiretroviral agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorothymidine F 18Also: [F-18] FluorothymidineA 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. | Drug | Fluorothymidine F 18 PET/CT |
Primary outcome
Percent Difference From Baseline IMRT Plan (%)
Time frame: Baseline (pre-treatment)
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.
5 secondary outcomes
Chemotherapy Compliance
Time frame: At 24 months
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21397965McGuire 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.
- Background: PubMed 21300484McGuire 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.
- Background: PubMed 20447554Menda 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.
- Results publication: PubMed 27319286McGuire 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.
- Results publication: PubMed 25207403McGuire 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.
- Individual participant dataSharing planned: Yes. Data are available upon request. A contract may need to be put into place, dependent upon data shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Buatti, PhD principal investigator
Department of Radiation Oncology, The University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluorothymidine F 18 in people with Uterine Cervical Neoplasms and Endometrial Neoplasms, run by John M. Buatti at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Difference From Baseline IMRT Plan (%) (time frame: Baseline (pre-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01717391, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.