Prospective Observational Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Volumetric/Dosimetric Changes During IMRT for bulky and postoperative head/neck patients
研究概览
简要总结
Anatomical changes that take place during Intensity modulated radiation therapy (IMRT) treatments for cancers of the head and neck cause significant dosimetric changes.
详细描述
The investigator's hypothesis is that those patients with bulky head and neck cancers who undergo definitive radiation therapy with or without chemotherapy have changes in their dose distribution that lead to significant changes in dose to tumor and/or normal tissue. It is possible for these dosimetric changes could occur in either those patients who undergo resection or not. In this study those patients who have undergone a resection will be stratified separately for analysis, however, this study is not powered to detect a difference between the two groups. The rational for stratification into an operated group of patients is that these patients will also lose weight in treatment and will provide us a detection of the magnitude of change in dose caused by weight loss independent of tumor shrinkage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •AJCC pathological stage I-IV cancers of the head and neck meeting the following criteria:
- •If gross total resection is performed it must be completed within 7 weeks of registration
- •Site of tumor origin in the nasopharynx, oral cavity, oropharynx, parotid, larynx, or hypopharynx (excluding lip, or sinuses)
- •Pretreatment evaluations required for eligibility include:
- •History and physical examination within four weeks prior to study entry
- •Dental evaluation with management according to the guidelines in Appendix IV prior to start of radiation
- •Serum pregnancy test, if applicable, within one week prior to study entry; urine dipstick test on the first day of treatment
- •Radiographic Studies: Pre-operative CT or MRI of the primary tumor and neck for clinical staging is required
- •Patients must be ≥ 18 years of age.
- •Women of childbearing potential (WOCBP) must be willing to consent to using effective contraception while on treatment.
- •Pregnant women are ineligible as radiation therapy involves unforeseeable risks to the embryo or fetus. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG], or in accordance with local regulations, whichever is more sensitive).
- •Patients must sign a study-specific informed consent form prior to registration.
排除标准
- •Histology positive for melanoma.
- •Gross (visible or palpable) disease left after surgery.
- •Less than gross total resection or patients requiring staged surgery.
- •Prior head and neck radiotherapy.
- •Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
结局指标
主要结局
Volumetric/Dosimetric Changes During IMRT for bulky and postoperative head/neck patients
时间窗: 7 weeks
To evaluate whether those patients undergoing standard intensity modulated radiation therapy (IMRT) for bulky and postoperative head and neck cancers demonstrate significant anatomic changes, causing dosimetric/volumetric changes during treatment which lead to under-dosing of tumor and/or over dosing of critical structures.
次要结局
- Number of Participants Requiring Re-Planning During the Course of IMRT for bulky and postoperative Head and Neck Cancer(7 weeks)
- Length of Time Required for Replanning of Radiation Therapy(7 weeks)
研究者
Cristiane Takita, MD
Professor of Clinical
University of Miami