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FLT PET Imaging for Cervical Cancer

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ClinicalTrials.gov Identifier: NCT01075412
Recruitment Status : Terminated (Study was closed and reopened as NCT01717391)
First Posted : February 25, 2010
Results First Posted : December 1, 2017
Last Update Posted : December 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasms Drug: [F18]Fluorothymidine Phase 2

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: `F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer
Actual Study Start Date : September 2009
Primary Completion Date : March 3, 2016
Study Completion Date : April 11, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group 2
Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.
Drug: [F18]Fluorothymidine
FLT PET scan 5 mCi (+/- 10%)
Other Name: FLT
Experimental: Group 1
Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.
Drug: [F18]Fluorothymidine
FLT PET scan 5 mCi (+/- 10%)
Other Name: FLT


Outcome Measures

Primary Outcome Measures :
  1. 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 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.


Secondary Outcome Measures :
  1. Chemotherapy Compliance [ Time Frame: post-treatment ]
    The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts.

  2. 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, and 30 days post 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

  3. Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. [ Time Frame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post 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

  4. 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, and 30 days post 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.

  5. Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. [ Time Frame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post 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


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Ability to understand and willingness to sign a written informed consent document.
  • Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of the cervix.
  • Scheduled to receive chemo-radiation for oncologic treatment.
  • Karnofsky of at least 60 at time of screening
  • Life expectancy of at least 6 months.
  • Leukocytes at least 3,000/microL
  • absolute neutrophil count at least 1,500/microL
  • platelets at least 100,000/microL
  • total bilirubin at maximum 1.0 mg/dL (UIHC limit of normal)
  • either ALT or AST less than 2.5 times the upper limit of normal
  • creatinine less than 1.5 times the upper limit of normal
  • non-pregnant, non-nursing, willing to use contraception

Exclusion Criteria:

  • oncology research protocol requiring full pelvic radiation (i.e., 4-field box technique) or experimental chemotherapy
  • 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 the study requirements.
  • subjects taking nucleoside analog medications such as those used as antiretroviral agents.
  • patients who have undergone hysterectomy or will have a hysterectomy as part of their cancer therapy.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075412


Locations
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Holden Comprehensive Cancer Center
Investigators
Study Director: Michael M Graham, Ph.D., M.D. The University of Iowa
Principal Investigator: Sarah McGuire, Ph.D. The University of Iowa
More Information

Publications:

Responsible Party: Sarah McGuire, Assistant Professor of Radiation Oncology, University of Iowa
ClinicalTrials.gov Identifier: NCT01075412     History of Changes
Other Study ID Numbers: 200906786
First Posted: February 25, 2010    Key Record Dates
Results First Posted: December 1, 2017
Last Update Posted: December 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes, data will be shared utilizing clinicaltrials.gov results

Keywords provided by Sarah McGuire, University of Iowa:
Positron-Emission Tomography
Radiotherapy, Intensity-Modulated

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female