A Pilot Trial of Image-Guided Adaptive Radiotherapy for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Dosimetric Comparisons With Adaptive Radiotherapy (ART) Planning to Intensity-modulated Radiation Therapy (IMRT) Planning
研究概览
简要总结
The goal of this clinical research study is to use computed tomography (CT) scans to measure and guide your radiation therapy. Researchers want to learn if the CT scans can be used to adapt radiation therapy to the changes in normal tissue and to the shrinking of the tumor that may occur as a reaction to radiation therapy. Researchers also want to see if magnetic resonance imaging (MRI) scanning can detect certain changes in the tumor any earlier than with standard tests.
详细描述
The Study Scans and Tests:
IMRT is a type of 3-dimensional (3-D) radiation therapy that can focus radiation beams directly on the tumor itself. In this study, the IMRT is given using a standard radiation machine (ExaCT™ machine) that has a CT scanner attached to it. This machine is commonly used in patients with head and neck cancer. It gives the same radiation treatment as most of the other machines at M. D. Anderson. However, in addition to giving radiation treatments, it can also perform CT scans while the patient is in the same position on the treatment table, before the radiation therapy is given.
For this study, your standard of care daily CT scans will be used to help researchers adjust participants' radiation therapy, if necessary, on a weekly basis. In particular, the changes in normal tissue that are being studied are any changes in the salivary glands. An additional research related MRI scan will also be performed in this study, but the MRI scan will not be used to adjust participants' therapy. Researchers want to learn if MRI scanning may be able to help doctors in the future to adjust someone's treatment based on changes in a tumor (its features and size) in response to radiation.
Enrollment in the Study:
If you agree to take part in this study, you will receive IMRT according to the standard schedule (over 6 - 7 weeks). You will sign a separate consent form for the IMRT, and the procedure and its risks will be explained to you at that time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years of age with histologically proven squamous cell carcinoma of the oropharynx, dispositioned to receive definitive radiotherapy for intact primary tumor.
- •Stage III, IVa, or IVb disease as defined by American Joint Committee on Cancer (AJCC) cancer staging criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
排除标准
- •Patients who have undergone definitive resection of the primary tumor.
- •Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer.
- •Prior radiation therapy to the head and neck region.
- •Patients unable or unwilling to give written, informed consent or to undergo MRI imaging.
- •Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study
- •Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated glomerular filtration rate (GFR) < 60 ml/min/1.73m
- •Patients who have had prior chemotherapy.
结局指标
主要结局
Dosimetric Comparisons With Adaptive Radiotherapy (ART) Planning to Intensity-modulated Radiation Therapy (IMRT) Planning
时间窗: Baseline by IMRT plan and adaptive dosing by ART plan evaluated during a 6-7 week course of treatment
Comparison of mean dose in the Contralateral Parotid Gland and Ipsilateral Parotid Gland change between one adaptive replan (ART1) and two adaptive replans (ART2) planning relative to standard intensity-modulated radiation therapy (IMRT) planning. Dosimetric comparisons was performed using paired t-testing between plans, with patients serving as their own controls. The median trigger point for ART1 was the 16th treatment fraction. For ART2 patients, the median trigger points for the first and second replanning were the 11th and the 22nd fractions, respectively. Percent change in mean dose calculated for each group as 100% (mean post baseline (ART1 or ART2) dosage minus mean baseline IMRT dose for each parotid gland
次要结局
- Number of Participants With Overall Shrinkage of Tumor With Adaptive Radiotherapy (ART)(Baseline by IMRT plan and adaptive dosing by ART plan evaluated at the end of the 6-7 week course of treatment)