Adjuvant Proton Whole Pelvis Radiation Therapy for Treatment of Post-Surgical Gynecologic Cancers
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Acute clinician-reported gastrointestinal (GI) toxicity.
研究概览
简要总结
This is a single institution, multi-center, Phase II, single-arm study, using Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) in the post-surgical, adjuvant setting for definitive treatment of gynecologic cancers. The purpose of this study is to estimate rate of acute clinician-reported gastrointestinal (GI) toxicity using WP PBS PRT in the definitive treatment of gynecologic cancers in the post-surgical, adjuvant setting.
详细描述
This is a single institution, multi-site study, and thus will include patients from geographic locations with Penn proton centers in the Philadelphia, Lancaster and South New Jersey area. The study will be conducted at the University of Pennsylvania Department of Radiation Oncology and associated Clinical facilities.
The study intervention is Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) as part of the definitive treatment of gynecologic cancers in the post-hysterectomy, adjuvant setting. Patients will be treated with doses of 45 or 50.4 Gy in 1.8 Gy daily fractions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed cervical or endometrial cancer
- •Indication for adjuvant whole pelvic radiation therapy, with or without systemic therapy
- •Age of 18 years or older
- •Written informed consent
- •ECOG of 0-2 within 3 months of enrolling
排除标准
- •Prior course of pelvic radiation
- •Metastatic disease outside of the pelvis
- •Active inflammatory bowel disease
- •Incapacity to provide informed consent
研究组 & 干预措施
Adjuvant Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)
The study intervention is Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) as part of the definitive treatment of gynecologic cancers in the post-hysterectomy, adjuvant setting. Patients will be treated with doses of 45 or 50.4 Gy in 1.8 Gy daily fractions. The volume treated will include the whole pelvis according to Radiation Therapy Oncology Group post-hysterectomy pelvis guidelines.
干预措施: Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) (Radiation)
结局指标
主要结局
Acute clinician-reported gastrointestinal (GI) toxicity.
时间窗: Up to 6 months after end of treatment at follow up visits
Determine the rate of acute clinician-reported gastrointestinal (GI), with the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria. Acute GI grade 2 or higher toxicity is the primary powering endpoint.
次要结局
- Acute clinician-reported genitourinary (GU) toxicity.(Up to 6 months after end of treatment at follow up visits)
- Loco-regional recurrence free survival, disease free survival, and overall survival.(Up to 2 years)
- Acute patient-reported gastrointestinal (GI) and genitourinary (GU) toxicity and quality of life.(Up to 6 months after end of treatment at follow up visits)