FLT PET Imaging for Cervical Cancer

Phase 2

Terminated

Conditions: Uterine Cervical Neoplasms

Interventions: Drug: [F18]Fluorothymidine

Registration Number: NCT01075412

Lead Sponsor: University of Iowa

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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 6

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	[F18]Fluorothymidine	Receives fourth \[F18\]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.
Group 1	[F18]Fluorothymidine	Receives fourth \[F18\]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.

Primary Outcome Measures

Name	Time	Method
Percent Difference From Baseline IMRT Plan (%)	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

Name	Time	Method
Chemotherapy Compliance	post-treatment	The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts.
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts	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
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.	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
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)	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.
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.	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