SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy, a Phase III Randomized Multicentric Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Absence of symtomps
研究概览
简要总结
Thisi is an Interventional drug-free randomized 1:1 open-label, multicenter, phase 3 trial in patients with first-line metastatic pancreatic cancer. The interventional group of patients will undergo radiotherapy on the primary lesion and SBRT on distal metastatic sites before receiving standard systemic therapy (chemotherapy), while the other group of patients will receive only standard systemic therapy (chemotherapy) without undergoing radiotherapy.
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
- •Patients diagnosed with pancreatic cancer, metastatic, candidate for first-line treatment standard systemic; either newly diagnosed in metastatic stage or first progression to metastasis.
- •Obtaining informed consent
- •Patients >18 years of age
- •Performance of imaging (CT with mdc, MRI with mdc, CT-PET with appropriate tracer) adequate for baseline local and systemic staging and likely to be similarly repeatable at 6 and 12 months after randomization
- •Confirmation at the time of randomization, by the Radiotherapy Center, that it is possible to perform all treatments potentially planned for the patient (if enrolled in experimental arm) within a maximum of 25 total days prior to referral to the Medical Oncology Center for systemic therapy
排除标准
- •Metastatic picture of line subsequent to the first
- •Technical or organizational impracticality to the eventual termination of radiation treatments Within 25 days after randomization
- •Inability to express independent consent to treatments
- •Pregnancy
- •Patient in hospice or with prognosis < 6 months
- •Predicted unavailability for follow-up at 6 months
- •Absence of adequate or likely non-repeatable pretreatment imaging study at 6 and 12 months
- •Previous radiation therapy
- •Previous radiometabolic therapy
- •Inability to maintain treatment position for SBRT
- •Symptomatic emergent or other presentation precluding study development as planned (e.g., epidural compression of the spinal cord or cauda equina)
- •Previous chemotherapy, immunotherapy or target therapy
研究组 & 干预措施
Standard systemic therapy (chemotherapy) without RT/SBRT
Patients will undergo only standard systemic treatment (chemotherapy drugs at the discretion of the oncologist) without receiving radiotherapy or stereotactic treatment.
干预措施: Standard systemic therapy (chemotherapy) without RT/SBRT (Drug)
RT / SBRT before standard systemic therapy (chemotherapy)
Combination of RT on primary pancreatic Gross Tumor Volume (GTV) (SBRT or RT) + SBRT on each of the distal lesions SBRT or RT will be delivered immediately before the initiation of systemic therapy ((chemotherapy drugs at the discretion of the oncologist))
干预措施: SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy (Radiation)
结局指标
主要结局
Absence of symtomps
时间窗: From the week after the treatment up to 12 months after
Comparison between the experimental arm and the standard arm in terms of pain reduction or absence of pain (particularly with regard to abdominal pain and widespread pain from disease) using NRS scale, one-dimensional 11-point scale that assesses pain intensity in adult
次要结局
- Pain level(From the week after the treatment up to 12 months after)
- Radiotherapy use(From the week after the treatment up to 12 months after)
研究者
Manfrida Stefania
Medical doctor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS