Introduction of the Maastro Applicator for Endoluminal Boosting in Rectal Cancer: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Clinical feasibility of the Maastro boosting technique.
研究概览
简要总结
The goal of this interventional pilot trial is to confirm that Maastro endoluminal HDR ( High Dose Radiation) contact brachytherapy boosting is feasible and may increase the chance of functional organ sparing of the rectum in patients with rectal cancer. Participants will be treated with chemoradiotherapy and an endoluminal boost with the Maastro applicator.
详细描述
The goal of this clinical trial is to confirm that Maastro endoluminal HDR contact brachytherapy boosting is feasible and may increase the chance of functional organ sparing of the rectum in patients with rectal cancer. If at least 7 out of 10 planned Maastro applicator treatment series (3 fractions per series) can be conducted successfully from a procedural point of view the treatment will be considered feasible. The study intervention will be similar to the study treatment of arm B of the OPERA trial. Opposed to the treatment in arm B of the OPERA trial, the endoluminal boost will be given using HDR brachytherapy with the Maastro applicator instead of a CXRT (Contact X-ray Radiotherapy) device. The dose profile of the Maastro applicator is similar to the dose profile of CXRT device. As in the OPERA trial patients will be stratified based on tumor size. As the diameter of the treatment field of the largest Maastro applicator (there are two sizes) equals 2.5 cm we will stratify for tumor diameter < 2.5 cm v ≥ 2.5 cm. In the OPERA trial patients were stratified for a tumor diameter of < 3.0 cm v ≥ 3.0 cm as currently the largest applicator diameter for the CXRT device is 3.0 cm (currently available applicators: 2.0, 2.5 and 3.0 cm). The endoluminal boost will consist of 3 fractions with a dose equivalent to 30 Gy per fraction prescribed at the surface of the applicator. The 3 boost fractions will be delivered over a 4-week time period (week 1-2-4). Conform OPERA protocol, patients with a tumor size < 2.5 cm will receive an upfront endoluminal HDR contact boost followed by concurrent chemoradiotherapy (25x1.8 Gy combined with capecitabine 825 mg/m2 bd on radiotherapy days). Patients with a tumor size ≥ 2.5 cm will first undergo concurrent chemoradiotherapy (25x1.8 Gy combined with capecitabine 825 mg/m2 bd on radiotherapy days) to first shrink the tumor and will receive the endoluminal HDR contact boost afterwards in order to eventually fit the tumor surface in the surface of the Maastro applicator.
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
- •≥ 18 years of age and capable of giving informed consent.
- •Adenocarcinoma of the rectum classified cT (clinical Tumor) 2-3b, < 5 cm largest diameter and < ½ circumference (MRI staging), N0-N1 (any node < 8 mm diameter), M0
- •Operable patient
- •Tumor accessible to the Maastro applicator with a distance from the lower tumor border to the anal verge ≤10 cm
- •No comorbidity preventing treatment
- •Adequate birth control for women of child-bearing potential
- •Follow-up possible.
排除标准
- •Tumor extending into the anal canal.
- •Stop of anti-coagulants (except ≤100 mg aspirin/day) is medically contraindicated.
- •Presence of coagulation disorder resulting in an increased bleeding risk.
- •Prior pelvic radiation therapy (excluding the abovementioned neoadjuvant treatment).
- •Prior surgery or chemotherapy for rectal cancer (excluding the abovementioned neoadjuvant treatment).
- •Inflammatory bowel disease (IBD).
- •(Systemic) treatment possibly causing rectal or genitourinary toxicity for a separate active malignancy.
- •World Health Organization performance status (WHO-PS) ≥
- •Life expectancy of < 6 months.
- •Pregnant women.
结局指标
主要结局
Clinical feasibility of the Maastro boosting technique.
时间窗: During treatment
If at least 7 out of 10 planned Maastro applicator treatment series (3 fractions per series) can be conducted successfully from a procedural point of view the treatment will be considered feasible.
次要结局
- Duration of the application procedure.(During treatment)
- Percentage of patients with G3 or higher rectal toxicity up to 3 months after treatment potentially attributable to endoluminal HDR contact brachytherapy.(3 months follow-up)
- Rectal toxicity scored according to CTCAE v. 5 up to 3 years after treatment.(3 years follow-up)
- Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum(3 years follow-up)
- Salvage surgery rate after treatment.(5 years follow-up)
- Clinical complete response rate up to 3 years after treatment.(3 years follow-up)
- Genitourinary toxicity scored according CTCAE v. 5 up to 3 years after treatment.(3 years follow-up)
- Long-term rectal functional outcome as measured by LARS 9 Low Anterior Resection Syndrome) score up to 3 years after treatment.(3 years follow-up)
- Overall and disease specific survival rate up to 5 year after treatment.(5 years follow-up)
- The diagnostic value of clinical response assessment using digital rectal examination, endoscopy and MRI after endoluminal radiation boosting using the Maastro applicator.(during follow-up)
- Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.(During treatment)
- Health status and quality of life as measured by QLQ (quality of life questionnaire)-C30 up to 3 years after treatment.(3 years follow-up)
- Health status and quality of life as measured by QLQ-CR29 (Colo Rectal) up to 3 years after treatment.(3 years follow-up)
- Health status and quality of life as measured by EQ-5D (EuroQol Five Dimensions Health Questionnaire) up to 3 years after treatment.(3 years follow-up)
- Local recurrence rate up to 5 years after treatment.(5 years follow-up)
- Complications within the first 30 days after completion of salvage total mesorectal excision (TME) surgery up to 3 years after treatment.(3 years follow-up)
- Metastatic rate up to 5 years after treatment.(5 years follow-up)
- Locoregional recurrence rate up to 5 years after treatment.(5 years follow-up)