LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs (OBLITERATE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of participants with controlled disease
研究概览
简要总结
This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.
详细描述
This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. Participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. Participants will be assigned stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy per the discretion of treating radiation oncologist and/or interventional radiologist.
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
- •Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:
- •Cohort A: Non-small cell cancer
- •Cohort B: Small cell cancer
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Age ≥18 years at time of consent.
- •Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.
- •≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. [Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment]
- •≤ 5 progressing or new metastatic lesions.
- •All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.
排除标准
- •Medical comorbidities precluding locally ablative therapies.
- •History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
- •Progressing intracranial lesions.
研究组 & 干预措施
Ablative local therapy
Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy
干预措施: Ablative local therapy (Device)
结局指标
主要结局
Number of participants with controlled disease
时间窗: 3 months from the first day of ablative local therapy
Number of participants with controlled disease at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy
次要结局
- Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy(Up to 2 years from the first day of ablative local therapy)
- Time to treatment failure(Up to 1 year from the first day of ablative local therapy)
- Median overall survival(Up to 1 year from the first day of ablative local therapy)
研究者
Megan Daly, MD
Principal Investigator
University of California, Davis