POSE (POs Surgery Endometrial Cancer) - Phase I/II Study to Access SBRT as a Replacement for Brachytherapy in Intermediate and High Risk in Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Reproducibility of vaginal cuff SBRT
研究概览
简要总结
This phase I/II feasibility study of hypo-fractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to the vaginal cuff in intermedium and high risk endometrial cancer. The primary endpoints are SBRT feasibility and dosimetrical reproducibility to HDR brachytherapy, inter/intra-fractional target motion assessment and toxicity rates. Secondary endpoints are quality of life measures, local control, disease free survival and overall survival.
详细描述
This phase I/II feasibility study of hypo-fractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to the vaginal cuff aims to reproduce adjuvant High Dose Rate (HDR) brachytherapy dose distributions in patients operated for intermediate and high risk endometrial carcinoma. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time on-line tracking. Eligible patients will receive three SBRT sessions to a prescription dose of 7 Gy to the vaginal cuff (with 4 to 7 days interval). SBRT will start within 4 to 8 weeks post-hysterectomy. The study will enroll a total of 30 patients. After treatment, patients will be followed-up at 3 months (+/- 6 weeks), at 6 (+/- 6 weeks) and every 6 months (+/- 6 weeks) thereafter for a total of 2 years. The duration of accrual in the study will be up to 3 years. Toxicity and outcome will be compared to published data on the standard modality of care (HDR brachytherapy). Patients' quality of life measures will be collected with validated questionnaires at the baseline and during follow up. Recurrence rates and survival data will be reported.
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
- •Pathology proven adenocarcinoma of the endometrium
- •National Comprehensive Cancer Network (NCCN) intermediate and high risk
- •Unstaged patients with < 50% myometrium invasion;
- •Age ≥ 18;
- •World health organization - Eastern Cooperative Oncology Group (WHO-ECOG) performance status 0-2 or Karnofsky performance status (KPS) ≥ 70;
- •Hemoglobin ≥ 8.0 g/dl; white blood cells count (WBC) ≥ 1,500/mm3 ; Platelets ≥ 40,000 cells/mm3 .
- •Signed informed consent
排除标准
- •Evidence of post-surgical macroscopic residual disease;
- •Patients with anatomical incompatibility with online tracking device;
- •Psychiatric conditions;
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
- •Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields;
- •Severe active co-morbidities.
结局指标
主要结局
Reproducibility of vaginal cuff SBRT
时间窗: Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time
Anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold
Adverse Events
时间窗: through study completion, an average of 5 years
Treatment related side effects based on CTCAE V3.0
Inter/intra fractional target motion
时间窗: during the 15 minutes of treatment delivery time
3D deviations recorded in CBCT images and electromagnetic recording
Dosimetric Feasibility of vaginal cuff SBRT
时间窗: through study completion, an average of 3 year
Fulfillment of protocol dosimetrical endpoints and constraints; physician assessment of complications (CTCAE V3.0) at specific time points during follow up (2 weeks, 3 and 6 months, then every 6 months until the end of the 3rd year, then annually until the end of the 5th year)
次要结局
- Local control(through study completion, an average of 5 years)
- Distant Relapse(through study completion, an average of 5 years)
- Quality of life metrics(through study completion, an average of 5 years)
研究者
Inês Antunes
Principal Investigator
Fundacao Champalimaud