NCT04989725招募中2 期
Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer: A Phase II Randomized Trial
Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
A registry-based randomized phase II trial. A total of 46 patients with metastatic cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Metastatic cancer (any histology), with pathological or radiological proof of metastasis
- •Ability to provide written informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Progressive disease while on systemic treatment (any line), defined as per RECIST criteria 1.1 on CT metrics as a greater than 20% increase in the sum measurement of lesions, non-target unequivocal progressive disease or a new lesion on CT.
- •Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.
- •All sites of disease can, in the opinion of the investigator, be safely treated and targetable with SABR (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)
- •Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.
排除标准
- •Pregnancy or breastfeeding
- •Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.
- •Presence of spinal cord compression
- •Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel
研究组 & 干预措施
Standard of care
Active Comparator
Switch to subsequent systemic therapy line, best supportive care or continue current systemic line
干预措施: Standard arm (Other)
Experimental SABR arm
Experimental
Definitive SABR to oligoprogressive lesions + continue current systemic therapy
干预措施: Experimental arm (Radiation)
结局指标
主要结局
Progression free survival
时间窗: 5 years
PFS defined from randomization to disease progression at any site or death
次要结局
- Overall survival(5 years)
- Quality of life Measured using the FACT-G tool, head and neck cancer-related patient reported outcome- CTCAE (PRO-CTCAE) and Quality of life 5-level EQ-5D(5 years)
- Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)(5 years)
- Time to next systemic therapy(5 years)
- Local control(5 years)
- Quality of life Measured using the FACT-G tool, patient reported outcome- CTCAE (PRO-CTCAE) and Quality of life 5-level EQ-5D(5 years)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
2 期
Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung CancerLung Cancer MetastaticNCT04405401Centre hospitalier de l'Université de Montréal (CHUM)68
已完成
2 期
Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic MelanomaLiver MetastasesLung MetastasesRecurrent MelanomaStage IV MelanomaTumors Metastatic to BrainNCT02107755Ohio State University Comprehensive Cancer Center8
进行中（未招募）
不适用
Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial)Metastatic CancerNCT02756793London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's90
进行中（未招募）
2 期
Management of Castration-Resistant Prostate Cancer with OligometastasesCastration-resistant Prostate Cancer Patients with OligometastasesNCT02685397Sir Mortimer B. Davis - Jewish General Hospital102
已完成
不适用
Radiosurgery for Patients Recurrent Oligometastatic DiseaseRecurrent Oligometastatic DiseaseNCT01345552Steven Burton173