Prospective Data Collection Initiative on MAASTRO HDR Rectal Applicator Treatments - a Prospective Observational Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 999
- 试验地点
- 1
- 主要终点
- Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum.
研究概览
简要总结
This registry will collect data from all patients treated with the MAASTRO HDR applicator. The goal is to deepen knowledge about dose-response relationships in rectal cancer boosting, which is essential for improving future treatment approaches and patient selection.
详细描述
Standard treatment for rectal cancer usually involves surgical removal of the tumor. Depending on the tumor's characteristics, patients may first receive neoadjuvant therapy such as radiotherapy, chemoradiotherapy, or total neoadjuvant treatment (TNT). These treatments aim to improve oncological outcomes and can lead to a complete response (CR) in about 10-40% of patients. When a CR occurs, patients may choose a watch-and-wait strategy, which avoids surgery and improves quality of life by preventing complications such as incontinence or the need for a stoma.
Increasing the radiation dose improves the chance of achieving a CR. Endoluminal boost techniques-high-dose-rate (HDR) brachytherapy and contact X-ray radiotherapy (CXRT)-allow a highly localized radiation boost. CXRT has shown higher CR rates than external beam radiotherapy (EBRT) boosts (81% vs. 60%). However, widespread use of endoluminal boosting is limited by the high cost of CXRT equipment and the less favorable dose distribution of HDR brachytherapy.
To overcome these limitations, MAASTRO, in collaboration with Varian Inc., developed a new HDR rectal brachytherapy applicator that delivers a dose profile similar to CXRT. The applicator has received CE certification and is now available for clinical use. A recent clinical trial confirmed that treatment with this applicator is clinically feasible. As a result, MAASTRO HDR treatment is now part of standard care.
To improve understanding of treatment outcomes and optimize future strategies, a prospective observational cohort study has been initiated.This project is designed to continuously include new patients and will provide an ongoing source for multiple future studies
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years.
- •Histological proof of rectal cancer, or a strong suspicion after imaging.
- •Treatment with MAASTRO HDR rectal applicator
- •Informed consent for longitudinal observational data collection.
排除标准
- •Mentally incompetent patients.
研究组 & 干预措施
Patients being treated with the MAASTRO HDR rectal applicator
Treatment with the MAASTRO HDR rectal applicator
结局指标
主要结局
Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum.
时间窗: From enrollment to the end of FU at 10 years
Number of patients with clinical complete respons. Number of patients with treatment related adverse events as assessed by CTCAE v 4.0
Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.
时间窗: During treatment
Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.
Duration of the application procedure.
时间窗: During treatment
Duration of the application procedure.
Clinical complete response rate up to 5 years after treatment.
时间窗: From end of treatment until 5 years after treatment
Clinical complete response rate up to 5 years after treatment.
Toxcity up to 3 year after treatment
时间窗: From start treatment until 3 years after the end of treatment
Rectal and genitourinary toxicity scored according to CTCAE v. 5 up to 3 years after treatment
Disease status up to 10 years after treatment
时间窗: from enrollment until 10 years after treatment
Local and locolregional recurrence rate and metastatic rate up to 10 years after treatment
Salvage surgery
时间窗: From end of treatment until 5 years after treatment
Salvage surgery rate after treatment.
Overall and disease specific survival rate
时间窗: from enrollment until 10 years after treatment
Overall and disease specific survival rate up to 10 year after treatment.
Discomfort/pain
时间窗: From baseline up to 2 weeks after last fraction
Discomfort/pain during endorectal irradiation using NRS (Numeric Rating Scale 0-10) painscore
次要结局
- Health status(From enrollment until 5 years after treatment)
- Long-term rectal functional outcome(From enrollment until 5 years after treatment)
- Quality of life questionnaires(From enrollment until 5 years after treatment)