Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II: A Phase II Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Acute bowel toxicity
研究概览
简要总结
Adjuvant radiotherapy (RT) plays an important role in reducing the risks of local recurrence after surgery in uterine cancers. Standard adjuvant pelvic radiation treatment targets the pelvic lymph nodes, the post-operative bed, and the upper vagina and is typically treated with intensity modulated radiation therapy (IMRT) which has been shown to improve patient reported gastrointestinal (GI) and genitourinary (GU) toxicities. Although pelvic radiation has been shown to be effective at decreasing locoregional recurrences, patient quality of life and experience can be significantly impacted as pelvic RT comprises of daily radiation for 25 daily treatments, which can be a substantial burden on patients with this disease. Hypofractionated radiotherapy to a dose of 30 Gy in 5 fractions (6 Gy given every other day) for adjuvant radiation treatment in uterine cancer is hypothesized to result in similar rates of acute gastrointestinal toxicities as conventional fractionated radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient with histologically confirmed endometrial adenocarcinoma, serous or clear cell carcinoma.
- •Patient is a candidate for adjuvant pelvic radiation for uterine cancer (+/- vault brachytherapy), meeting one of the following conditions:
- •High grade histology (including serous and clear cell) OR Outer-half myometrial invasion and International Federation of Gynecology and Obstetrics (FIGO) grade 1-2 OR FIGO stage II - III.
- •Patients who are to receive adjuvant systemic therapy sequentially in addition to pelvic radiotherapy will be eligible.
- •Age ≥18 years.
- •Patient is willing and able to give informed consent to participate in this clinical trial.
排除标准
- •Patient has had prior pelvic radiotherapy.
- •Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
- •Patient planned for concurrent chemoradiation therapy.
结局指标
主要结局
Acute bowel toxicity
时间窗: Baseline to 2 years following RT completion
To compare the acute bowel toxicities associated with hypofractionated vs conventional adjuvant pelvic radiation as measured by the The Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
次要结局
- Acute bowel toxicities(Baseline to 2 years following RT completion)
- Acute urinary toxicities through CTCAE(Baseline to 2 years following RT completion)
- Acute urinary toxicities through EPIC(Baseline to 2 years following RT completion)
- Local- regional failure(Baseline to 2 years following RT completion)
- Disease-free survival(Baseline to 2 years following RT completion)
- Quality of life using EORTC QLQ-30 and endometrial module (EN-24)(Baseline to 2 years following RT completion)
- Correlation of GU toxicity, EORTC, and EPIC(Baseline to 2 years following RT completion)
研究者
Dr. Eric Leung
Principal Investigator
Sunnybrook Health Sciences Centre