'F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Percent Difference From Baseline IMRT Plan (%)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Group 2
Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.
干预措施: [F18]Fluorothymidine (Drug)
Group 1
Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.
干预措施: [F18]Fluorothymidine (Drug)
结局指标
主要结局
Percent Difference From Baseline IMRT Plan (%)
时间窗: 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.
次要结局
- Chemotherapy Compliance(post-treatment)
- 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)
- 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)
- 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)
- 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)
研究者
Sarah McGuire
Assistant Professor of Radiation Oncology
University of Iowa