Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS): A Phase I/II Study (SPARTACUS)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Acute toxicities
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 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 - IIIC
- •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.
排除标准
- •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.
结局指标
主要结局
Acute toxicities
时间窗: Baseline to 12 weeks following RT completion
To assess the acute urinary and bowel toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer using CTCAE.
次要结局
- Disease-free survival(Study activation through 2 years post-RT)
- Quality of life through EORTC QLQ-C30 and EN24(Study activation through 2 years post-RT)
- Late toxicities(12 weeks post-RT to 2 years post-RT)
- Local-regional failure(Study activation through 2 years post-RT)
- Dosimetric feasibility(Baseline to RT completion)
研究者
Dr. Eric Leung
Principal Investigator
Sunnybrook Health Sciences Centre