NCT03808662进行中（未招募）2 期
Precision Radiation for OligoMetastatIc and MetaStatic DiseasE (PROMISE)-004: Consolidative Use of Radiotherapy to Block (CURB) Oligoprogression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 107
- 试验地点
- 10
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is determine if receiving stereotactic body radiation(SBRT) when participants' metastatic tumors have just begun to grow increase the length of time before disease gets worse
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
- 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
- •Age 18 or older
- •Willing and able to provide informed consent
- •Metastatic disease detected on imaging and histologically confirmed:
- •Triple negative breast cancer TNBC (ER <1%, PR <1%, her-2-neu 0- 1+ by IHC or FISH-negative or as determined by MD discretion)
- •OR NSCLC (without known EGFR mutation or ALK/ROS1 rearrangement)
- •OR Other high-risk breast cancer (per physician's discretion) progressed on hormone or systemic therapy, regardless of ER/HER2 status
- •OR NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations with disease progression on first-line tyrosine kinase inhibitor
- •Biopsy of metastasis prior to enrollment is per treating physician's discretion per standard of care. It is preferred but not required.
- •These patients are selected for the study given the similar survival outcomes when given standard of care therapies
- •Patient has received at least first-line prior treatment with systemic therapy (either cytotoxic or targeted, including maintenance therapies).
- •Patients who received prior immunotherapy are allowed.
- •Patients who had any prior radiation therapy near or overlapping with the oligoprogressive sites are allowed to enroll.
- •Patients with the following medical conditions precluding them from participating in other systemic therapy or drug trials are allowed:
- •active liver disease, including viral or other hepatitis, or cirrhosis
- •any other significant medical condition not under control, including any acute coronary syndrome within the past 6 months.
- •a permanent pacemaker
- •a QTc > 480 ms in the baseline EKG
- •peripheral neuropathy of grade >/= 2 per NCI CTCAE
- •history or known autoimmune disease
- •current chronic systemic steroid therapy or any immunosuppressive therapy
- •history of primary immunodeficiency or solid organ transplant
- •known positive human immunodeficiency virus (HIV), chronic or active hepatitis B or C, or active hepatitis A
- •active infection requiring systemic antibiotic therapy
- •Patients can have more than 5 metastases but can only have 1-5 oligo-progressive lesions.
- •Oligoprogression, defined as Response Evaluation Criteria in Solid Tumors (RECIST) or Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) documented progression in up to 5 individual lesions
- •Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria as a guide:
- •At least a 20% increase in the sum of the longest diameter (LD) of the lesion, taking as reference the smallest sum LD recorded since the last imaging OR
- •The appearance of one or more new lesions OR
- •New/malignant FDG uptake in the absence of other indications of progressive disease or an anatomically stable lesion OR
- •>/= 5mm increase in the diameter sum of the lesion
- •Using Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) as a guide:
- •>30% increase in 18F-FDG SUV peak, with >0.8 SUV units increase in tumor SUV from the baseline scan in pattern typical of tumor and not of infection/treatment effect OR
- •Visible increase in the extent of 18F-FDG tumor uptake OR
- •New 18F-FDG avid lesions typical of cancer (including new bone lesion) and not related to treatment effect and/or infection
- •Development of a new soft tissue metastatic lesion at least 5mm in size or any new bone metastasis
- •Progressive enlargement of a known metastasis on 2 consecutive imaging studies at least 2 months apart with a minimum 5mm increase in size
- •All sites of oligoprogression can be safely treated
- •Maximum 5 progressing metastases in any single extra-cranial organ system (i.e. lung, liver, bone)
- •a. If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI
- •No restriction on the total number of metastases
- •Note: If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.
- •For patients with brain metastases and oligoprogression elsewhere where stereotactic radiation to the brain is warranted, the brain lesions can be treated prior to randomization. This will not be counted toward the 5 progressive lesions.
- •Any symptomatic metastatic sites requiring prompt palliative radiation (e.g. cord compression) can also be treated with standard of care radiation prior to randomization. This will not be counted toward the 5 progressive lesions.
- •If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.
排除标准
- •Pregnancy.
- •Leptomeningeal disease.
- •Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma.
- •Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study.
研究组 & 干预措施
Arm 1: Early Stereotactic Body Radiotherapy/SBRT
Experimental
SBRT to all oligoprogressive sites
干预措施: Sterotactic Body Radiotherapy/SBRT (Radiation)
Arm 2:Standard of Care
Active Comparator
干预措施: Standard of care (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Up to 52 weeks after final participant is enrolled
To study if the addition of early SBRT to extra-cranial oligo-progressive metastatic disease could prolong PFS compared to no SBRT. PFS is defined as the time from randomization to disease progression or death.
次要结局
- Overall survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
研究者
研究点 (10)
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