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

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
John M. Buatti, University of Iowa
ClinicalTrials.gov Identifier:
NCT01717391
First received: October 18, 2012
Last updated: August 1, 2017
Last verified: August 2017
  Purpose
[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.

Condition Intervention Phase
Uterine Cervical Neoplasms Endometrial Neoplasms Anus Neoplasms Rectal Neoplasms Prostatic Neoplasms Drug: fluorothymidine F 18 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Pelvic Cancer Patient Chemoradiotherapy Outcomes With FLT PET Imaging

Resource links provided by NLM:


Further study details as provided by John M. Buatti, University of Iowa:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 36
Study Start Date: October 2012
Study Completion Date: April 2017
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717391

Locations
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: John Buatti, PhD Department of Radiation Oncology, The University of Iowa
  More Information

Publications:

Responsible Party: John M. Buatti, Professor of Radiation Oncology, University of Iowa
ClinicalTrials.gov Identifier: NCT01717391     History of Changes
Other Study ID Numbers: 201204712
R01CA169336 ( U.S. NIH Grant/Contract )
Study First Received: October 18, 2012
Results First Received: June 30, 2017
Last Updated: August 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared utilizing clinicaltrials.gov

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John M. Buatti, University of Iowa:
radiotherapy
Positron-Emission Tomography and Computed Tomography
chemotherapy
bone marrow

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Rectal Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Pelvic Neoplasms
Anus Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Anus Diseases
Dideoxynucleosides
Alovudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 20, 2017