Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS (SPARTACUS)
Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS): A Phase I/II Study (SPARTACUS)
Advanced technology has enabled radiation oncologists to more accurately and precisely target radiation to areas at risk while maximally sparing healthy tissue. A secondary result of these technologic advances has been the increased utilization of hypofractionationed treatment protocols, since the combined ability to better visualize and precisely deliver radiation to target volumes has allowed radiation oncologists to leverage the therapeutic ratio toward higher target doses whilst maintaining safe doses to the pertinent organs-at-risk. The spectrum of hypofractionation ranges from what are considered moderate (ie. 2- 5 Gy / fraction) into the realm of what is more commonly referred to as stereotactic body (SBRT), generally >5 Gy / fraction. There is growing evidence demonstrating both safety and efficacy for SBRT. The investigators propose that these advantages are translatable to the adjuvant treatment of endometrial cancer.
The investigators submit that a prescription dose of 30 Gy in 5 fractions. Through precision delivery and careful dosimetry the treatment should be safe and well tolerated with minimal impact on patient quality of life.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M4N 3M5
- Sunnybrook Health Sciences Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically confirmed endometrial adenocarcinoma
Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions:
- Patient has serous, clear cell, carcinosarcoma or differentiated histologies.
- Outer-half myometrial invasion and FIGO grade 1-2 OR
- FIGO stage II - IIIC1.
- Willing and able to give informed consent to participate in this clinical trial.
- Age ≥18 years.
- Are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments.
- Willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol.
- Primary language of the patient must be English or, if a patient's primary language is not English, they are still able to participate provided the QLQ-C30 and EN-24 is available in their primary language.
Exclusion Criteria:
- Has had prior pelvic radiotherapy.
- Has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
- Has a contraindication to iodinated CT contrast.
- Has a hip prosthesis.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Hypofractionated Pelvic Radiation
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Patients will be planned with the aim of delivering 30 Gy in 5 fractions.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acute toxicities
大体时间：Baseline to 12 weeks following RT completion
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To assess the acute urinary and bowel toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer using CTCAE.
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Baseline to 12 weeks following RT completion
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of life through EORTC QLQ-C30 and EN24
大体时间：Study activation through 2 years post-RT
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To assess the effect of adjuvant SBRT treatment on acute and late patient reported health quality of life using EORTC questionnaires.
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Study activation through 2 years post-RT
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Late toxicities
大体时间：12 weeks post-RT to 2 years post-RT
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To assess the late urinary, bowel, and other toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer using CTCAE.
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12 weeks post-RT to 2 years post-RT
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Local-regional failure
大体时间：Study activation through 2 years post-RT
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To assess the local-regional failure of adjuvant SBRT treatment by observation of progression or persistence of disease.
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Study activation through 2 years post-RT
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Disease-free survival
大体时间：Study activation through 2 years post-RT
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To document the disease-free survival of those treated with adjuvant SBRT
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Study activation through 2 years post-RT
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Dosimetric feasibility
大体时间：Baseline to RT completion
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The number of patients eligible for enrollment at a 30Gy prescription dose based rigid dosimetric constraints, as compared to a 27.5 Gy treatment dose.
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Baseline to RT completion
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合作者和调查者
调查人员
- 首席研究员：Eric Leung, MD、Sunnybrook Health Sciences Centre
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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