NCT05295992进行中（未招募）不适用
Daily Online Adaptive Radiation Therapy of Bladder Cancer for Reduction of Intestinal Toxicity: A Prospective Trial Using an Individualized Approach and Conventional Fractionation (ARTIA-Vesica)
Varian, a Siemens Healthineers Company1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年3月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Early Rate CTCAE GI Toxicity
研究概览
简要总结
This is a single-arm, prospective, Phase II, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle invasive bladder cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).
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
- •Histologically proven bladder cancer
- •Urothelial carcinoma
- •Age ≥ 18 years
- •Stage T1b-T4AN0M0
- •TUR-B and PET-CT or CT of thorax/abdomen/pelvis within 8 weeks prior to inclusion
- •Suitable for radiotherapy
- •ECOG/WHO performance status 0-2
- •Written informed consent
- •For Cohort B, participant's must have normal organ and marrow function as defined below:
- •leukocytes ≥2,500/mcL
- •absolute neutrophil count ≥1,500/mcL
- •platelets ≥100,000/mcL
- •hemoglobin ≥9 g/dL
- •total bilirubin ≤ 1,5 ULN
- •AST(SGOT)/ALT(SGPT) ≤3 × ULN
- •alkaline phosphatase ≤2.5 × ULN
- •creatinine clearance <25 ml/min We recommend avoiding cisplatin for participants with creatinine clearance <50 ml/min.
- •INR and aPTT £1.5 ULN
排除标准
- •Prior pelvic radiation therapy
- •Inability to comply with the protocol
- •Presence of a hip prothesis
- •Grade 2 or greater baseline diarrhea
- •Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease)
研究组 & 干预措施
Daily Adaptive External Beam Radiation Therapy
Experimental
Daily adaptive radiation therapy delivered with Varian Ethos treatment system.
干预措施: Varian Ethos Adaptive Radiation Therapy (Device)
结局指标
主要结局
Early Rate CTCAE GI Toxicity
时间窗: Start of radiotherapy to 3 months after end of radiotherapy
Change of the peak early rate of external beam radiation therapy treatment-related (CTCAE) grade 2+ diarrhea
次要结局
- Overall Survival(From time of inclusion to death from any cause, assessed up to 24 months post treatment)
- Disease Free Survival(From time of inclusion to death from bladder cancer, assessed up to 24 months post treatment)
- Local Progression Free Survival(From time of inclusion to local progression, assessed up to 24 months post treatment)
- Progression Free Survival(From time of inclusion to disease progression, assessed up to 24 months post treatment)
- Patient Reported Outcomes (PRO)(Baseline through 2 year follow-up)
- EORTC Quality of Life Assessment(Baseline through 2 year follow-up)
- EuroQol Quality of Life Assessment(Baseline through 2 year follow-up)
- Local Control(At 12 and 24 months)
- Workflow Feasibility(From start of radiation therapy through end of external beam treatment (approximately 6 weeks))
- All Early CTCAE Treatment Related Toxicities(From start of radiotherapy through 3 months after end of radiotherapy)
- All Late CTCAE Treatment Related Toxicities(From 3 months after end of radiotherapy through 2 years follow-up)
- Treatment Related Hospitalization(From of start of radiation therapy through 2 year follow-up)
研究者
研究点 (1)
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