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

NCT01717391CompletedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

John M. Buatti

Enrollment

36

Start Date

2012-10-01

Completion Date

2016-02-29

Study Type

INTERVENTIONAL

Official Title

Improving Pelvic Cancer Patient Chemoradiotherapy Outcomes With FLT PET Imaging

Interventions

fluorothymidine F 18

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsAnus NeoplasmsRectal NeoplasmsProstatic Neoplasms

Eligibility

Age Range

18 Years+

Sex

ALL

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.

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 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.

Time frame: Baseline (pre-treatment)

Secondary Outcomes

Chemotherapy Compliance

The number of participants who had chemotherapy withheld at least once for low blood counts.

Time frame: At 24 months

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, 30 days and 1 year after 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, 30 days and 1 year after 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, 30 days and 1 year after 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, 30 days and 1 year after treatment

Locations

Holden Comprehensive Cancer Center, Iowa City, United States