NCT04386993已完成不适用
De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer (DeCRESCEndo)
适应症
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
- Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events
研究概览
简要总结
The goal of this study is to evaluate short course radiation in the post-operative female pelvis after hysterectomy in stage III-IVA endometrial adenocarcinoma patients, or any stage patients with uterine serous or carcinosarcoma histology. The investigators hypothesize that short course pelvic radiation will have an acute and late grade 3-4 toxicity rate < 10%, and patients will benefit from both convenient and effective loco-regional control comparable to the traditional 5-6 weeks of radiation.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed stage IIIA-IVA endometrial cancer, or any stage I-IVA where any proportion of the tumor is uterine serous, clear cell, de-differentiated, or carcinosarcoma histology.
- •Must have already undergone radical hysterectomy. Hysterectomy may have occurred no more than one year prior to enrollment.
- •At least 18 years of age.
- •ECOG performance status ≤ 2
- •Minimal bone marrow and organ function as defined below:
- •Leukocytes ≥ 1,000 cumm
- •Absolute neutrophil count ≥ 500 cumm
- •Platelets ≥ 50,000 cumm
- •Hemoglobin ≥ 7g/dL
- •Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
排除标准
- •Prior radiation to the pelvis.
- •Currently receiving any investigational agents.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, inflammatory bowel disease, or irritable bowel disease.
- •Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
结局指标
主要结局
Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events
时间窗: From start of radiation through Day 90
Incidence of late hematologic, gastrointestinal, and genitourinary adverse events
时间窗: From Day 91 through month 12
次要结局
- Change in patient-reported urinary and gastrointestinal toxicity as measured by PRO-CTCAE(Baseline, 2 weeks, and 3 months post-completion of radiation)
- Change in quality of life as measured by FACT-En(Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation)
- Distant control(Up to 12 months post-completion of radiation)
- Overall survival(Up to 12 months post-completion of radiation)
- Change in patient-reported urinary and gastrointestinal toxicity as measured by bowel/bladder domains of EPIC-26(Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation)
- Locoregional control(Up to 12 months post-completion of radiation)
- Disease-free survival(Up to 12 months post-completion of radiation)
研究者
研究点 (2)
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