Adaptive Fractionation in Online Adaptive Stereotactic Radiotherapy for Abdominopelvic Lymph Node Oligometastases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving ≥30% reduction in number of online-adaptive fractions compared with the standard 5-fraction SBRT course.
研究概览
简要总结
Oligometastases, a state of cancer with up to five metastases, was traditionally treated with systemic treatments like chemotherapy. Treatment with stereotactic body radiotherapy (SBRT) showed a high local control and improved disease-free survival.
The use of SBRT also allows for the deferral of systemic treatment, thereby delaying its potential side effects. SBRT enables the delivery of a high dose to the tumor while minimizing the dose to organs at risk, reducing normal tissue damage, however, toxicity remains a potential issue in the abdominopelvic region, where lymph node oligometastases are often located near highly mobile, radiosensitive organs like the bowel.
Online adaptive radiotherapy is used to address this issue, adapting the treatment plan to the anatomy of the day. Unfortunately, adaptive radiotherapy results in longer treatment delivery times than conventional radiotherapy. This can potentially be countered by increasing the fraction dose and reducing the number of fractions if the patient anatomy allows it. This is convenient for the patient as it reduces the number of hospital visits, and it could also reduce the total workload for the hospital.
Therefore, there is not only a benefit of a reduction in toxicity by adaptive treatment, but also in reducing the total treatment time. This study aims to investigate if the number of adaptive fractions can be reduced by 30% for patients with abdominal or pelvic lymph node oligometastases.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with abdominal and/or pelvic lymph node recurrences of solid tumors.
- •No more than 5 metastatic lesions in no more than 2 organs and a controlled primary tumor site.
- •Diagnostic imaging includes at least a PET scan or CT thorax/abdomen, of which one is not older than 4 weeks at the time of referral for SBRT.
- •Primary tumor must be treated at least 4 months before the diagnosis of metastasis.
- •Patients must be 18 years or older.
- •Written informed consent.
排除标准
- •Prior radiotherapy in the same field.
- •Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years.
- •Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
研究组 & 干预措施
Online-Adaptive SBRT
干预措施: Online-Adaptive SBRT (Radiation)
结局指标
主要结局
Proportion of participants achieving ≥30% reduction in number of online-adaptive fractions compared with the standard 5-fraction SBRT course.
时间窗: From enrollment to the end of treatment at 1 month.
For each participant, the number of online-adaptive fractions actually delivered will be recorded. The reduction will be calculated as: (standard - delivered) / standard \* 100%.
次要结局
- Overall survival (time-to-event in months) from start of SBRT(From first day of treatment up to 48 months.)
- Local control at the treated site assessed by RECIST v1.1(At 12, 24, and 36 months after treatment.)
- Participants with treatment-related acute adverse events (CTCAE v5.0)(From first day of treatment to 90 days after last fraction.)
- Participants with treatment-related late adverse events (CTCAE v5.0)(>90 days after last fraction to 24 months.)
- Magnitude of intra- and interfraction bowel displacement on CBCT (mm)(Assessed at each delivered fraction from the first fraction through the final delivered fraction (up to 5 fractions over up to 2 weeks).)
- Treatment fractions requiring patient re-alignment due to intrafraction motion (CBCT-guided adaptive workflow)(Assessed at each delivered fraction from the first fraction through the final delivered fraction (up to 5 fractions over up to 2 weeks).)
研究者
Joost J. M. E. Nuyttens
Principal Investigator
Erasmus Medical Center