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Improving Pelvic Cancer Patient Chemoradiotherapy Outcomes With FLT PET Imaging

Phase 2
18 Years
Open (Enrolling)
Uterine Cervical Neoplasms, Endometrial Neoplasms, Anus Neoplasms, Rectal Neoplasms, Prostatic Neoplasms

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Trial Information

Improving Pelvic Cancer Patient Chemoradiotherapy Outcomes With FLT PET Imaging

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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in FLT uptake as measured by PET/CT scanning

Outcome Description:

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.

Outcome Time Frame:

baseline, weeks 1 and 2 of therapy, 1 month post radiation therapy, and 1 year post radiation therapy

Safety Issue:


Principal Investigator

Sarah McGuire, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiation Oncology, The University of Iowa


United States: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

December 2016

Related Keywords:

  • Uterine Cervical Neoplasms
  • Endometrial Neoplasms
  • Anus Neoplasms
  • Rectal Neoplasms
  • Prostatic Neoplasms
  • radiotherapy
  • Positron-Emission Tomography and Computed Tomography
  • chemotherapy
  • bone marrow
  • Anus Neoplasms
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Endometrial Neoplasms
  • Prostatic Neoplasms
  • Rectal Neoplasms
  • Adenoma
  • Pelvic Neoplasms



Holden Comprehensive Cancer Center Iowa City, Iowa  52242-1009