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[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers

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ClinicalTrials.gov Identifier: NCT01717391
Recruitment Status : Completed
First Posted : October 30, 2012
Results First Posted : September 5, 2017
Last Update Posted : September 5, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

October 18, 2012
October 30, 2012
June 30, 2017
September 5, 2017
September 5, 2017
October 2012
February 2016   (Final data collection date for primary outcome measure)
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.
Changes in FLT uptake as measured by PET/CT scanning [ Time Frame: baseline, weeks 1 and 2 of therapy, 1 month post radiation therapy, and 1 year post radiation therapy ]
Standardized uptake values of the FLT tracer signal in pelvic bone marrow will be used to create patient-specific bone marrow spatial maps to reduce bone marrow dose during radiation therapy planning. Changes in uptake will be assessed in relation to the radiation therapy plan.
Complete list of historical versions of study NCT01717391 on ClinicalTrials.gov Archive Site
  • Chemotherapy Compliance [ Time Frame: At 24 months ]
    The number of participants who had chemotherapy withheld at least once for low blood counts.
  • 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 ]
    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
  • 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 ]
    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
  • 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 ]
    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
  • 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 ]
    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
  • Adverse event frequency [ Time Frame: weekly during radiation treatment treatment for up to 8 weeks; then at 1 month, 3 months and 1 year post-radiation ]
    Assess grade 2 and higher adverse events. Evaluate the relationship between radiation dose, the bone marrow spatial map, and the adverse event frequency and profile.
  • Blood Cell Counts [ Time Frame: baseline, weekly during radiation treatment for up to 8 weeks, 30 days and 1 year after treatment ]
    Blood counts will be recorded to assess the effect of radiation dose on pelvic bone marrow activity.
  • Chemotherapy Compliance [ Time Frame: At 24 months ]
    The amount of chemotherapy administered will be compared to the amount of chemotherapy prescribed. A secondary comparison against the level of bone marrow suppression (as measured by both the blood cell counts and FLT PET/CT scans) may also be performed. This cannot be assessed until the participant has completed their entire prescribed course of chemotherapy, which will vary based on their tumor type.
Not Provided
Not Provided
 
[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers
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.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Uterine Cervical Neoplasms
  • Endometrial Neoplasms
  • Anus Neoplasms
  • Rectal Neoplasms
  • Prostatic Neoplasms
Drug: 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.
Other Name: [F-18] Fluorothymidine
Experimental: Fluorothymidine F 18 PET/CT
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.
Intervention: Drug: fluorothymidine F 18

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
April 2017
February 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

    • 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)

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01717391
201204712
R01CA169336 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Data will be shared utilizing clinicaltrials.gov
John M. Buatti, University of Iowa
University of Iowa
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Principal Investigator: John Buatti, PhD Department of Radiation Oncology, The University of Iowa
University of Iowa
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP