Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers (HERA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Evaluate acute radiation toxicity
研究概览
简要总结
After surgery to remove the main endometrial and/or cervical tumor, most women receive radiation therapy. This study uses hypo-fractionated radiation therapy, which is a type of radiation therapy in which the total prescribed dose of radiation is delivered in fewer but larger doses than conventional or standard radiotherapy.
This research study aims to determine if hypo-fractionated radiation therapy given after surgery can improve treatment tolerability (i.e., fewer treatments) with comparable side effects.
Participants will be in the study for about 5 years:
Radiation therapy:
- 5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT).
- Each treatment session will occur on a weekday (typically consecutive weekdays) and will last approximately an hour.
Treatment Follow-Up:
- Check-up Appointment and answer questions at 3 months post RT
- Check-up Appointments with physical exam every 6 months (+/- 4 weeks) for up to 5 years.
详细描述
The investigators hypothesize that adaptive planning with either computed tomography (CT) or magnetic resonance imaging (MRI) guidance may offer improved SBRT plans for postoperative gynecological cancer patients due to issues with anatomic variation between and during fractions of radiation therapy. Treatment on an MRI-guided linear accelerator with adaptive planning capabilities has been shown to significantly improve acute toxicity in the setting of prostate SBRT compared to conventional linear accelerators.10 The investigators, therefore, propose using adaptive planning with CT- or MRI-guidance to deliver 30 Gy in 5 fraction adjuvant SBRT to the pelvis for endometrial and cervical cancer patients.
Stereotactic Body Radiation Therapy (SBRT) with adaptive planning will be delivered following surgical resection of the primary tumor. Patients will receive 6.0 Gy x 5 fractions delivered once every other day. Patients will not be treated on weekends or holidays as is standard practice for radiation treatments.
Patients will be seen by the radiation oncologist within the first 3 months after completion of radiation therapy. For patients who live a distance far enough away from the University of California at Los Angeles (UCLA) where travel would be challenging for the patient, a phone or telemedicine follow-up will be considered acceptable. After this, follow-up will be performed every 6 months (+/- 4 weeks) for 5 years following completion of radiotherapy. Patients will be followed clinically and/or radiographically per physician discretion.
SCHEMA
Diagnosis of endometrial or cervical cancer
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
- •Histologically confirmed endometrial or cervical cancer
- •Surgical resection of the primary tumor
- •International Federation of Gynecology and Obstetrics (FIGO) Stage IA-IVB endometrial cancer OR FIGO Stage IA-IIA cervical cancer that meets indications for receiving adjuvant pelvic radiotherapy alone as standard of care
- •Age ≥ 18 years old
- •Karnofsky performance status (KPS) ≥ 60 or Eastern Cooperative Oncology Group (ECOG) 0-2
排除标准
- •Must not meet indications for receiving concurrent chemotherapy as standard of care
- •Active treatment of a separate malignancy
- •History of prior irradiation to the area to be treated
研究组 & 干预措施
Hypofractionated External beam Radiotherapy
5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT).
干预措施: External beam Radiotherapy (Radiation)
结局指标
主要结局
Evaluate acute radiation toxicity
时间窗: treatment to 12 weeks after completion of radiotherapy
Evaluate acute radiation toxicity according to Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0). Acute toxicity is defined as treatment-related adverse events occurring within 12 weeks of completion of radiotherapy.
次要结局
- Evaluate late toxicity(12 weeks after completion of radiotherapy until 5 years after completion of radiotherapy)
- Evaluate local control(treatment to 5 years after completion of radiotherapy)
- Evaluate regional control(treatment to 5 years after completion of radiotherapy)
- Evaluate patient-reported quality-of-life European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-EN24)(treatment to 24 weeks after completion of radiotherapy)
- Evaluate distant metastasis(treatment to 5 years after completion of radiotherapy)
- Evaluate patient-reported quality-of-life European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)(treatment to 24 weeks after completion of radiotherapy)
- Evaluate progression-free survival(treatment to 5 years after completion of radiotherapy)