FLT PET Imaging for Cervical Cancer

NCT01075412TerminatedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

University of Iowa

Enrollment

6

Start Date

2009-09-01

Completion Date

2016-03-03

Study Type

INTERVENTIONAL

Official Title

'F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer

Interventions

[F18]Fluorothymidine

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Percent Difference From Baseline IMRT Plan (%)

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.

Time frame: Baseline (pre-treatment)

Secondary Outcomes

Chemotherapy Compliance

The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts.

Time frame: post-treatment

Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts

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

Time frame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment

Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.

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

Time frame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment

Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)

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.

Time frame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment

Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.

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

Time frame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment

Locations

Holden Comprehensive Cancer Center, Iowa City, United States

FLT PET Imaging for Cervical Cancer