First Line gastroeSOphageal metastatiC canceR primAry and disTant (if Oligometastatic) lEsions-directed Radiotherapy, a Multicentric, Phase III, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Disappearance of symptoms
研究概览
简要总结
The aim of the study is to evaluate the efficacy of radiotherapy on the primary site of gastroesophageal cancer and extracranial stereotactic radiotherapy on metastases before the use of standard systemic therapy, in cases of limited disease burden (in the experimental group), compared to the standard group, which does not receive radiotherapy. This prospective, multicenter, randomized trial aims to evaluate the efficacy of the unconventional approach versus the conventional one in increasing the percentage of asymptomatic patients due to the direct effect of the primary tumor or metastases. "Randomized" means that the assignment to one of the treatment groups mentioned above will be random, not influenced by the physician or the patient's condition. Therefore, your participation in either of the two treatments under study will be assigned randomly and not predetermined. This randomness is crucial for a proper analysis of the results at the end of the study, which will help clarify whether there are differences between the two proposed treatments. This also means that you may not receive direct benefits from participating in this study, as it is a research study.
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 gastroesophageal cancer (i.e.: esophagus, gastroesophageal junction, stomach), for both major squamous cell (SCC) and adenocarcinomatous (ADK) histologies, metastatic, candidate for first-line standard systemic treatment; 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 Radiation Therapy Center, that all potentially planned treatments can be performed for the patient (if enrolled in experimental arm) within a maximum of 25 days total before referral to the Medical Oncology Center for systemic therapy
排除标准
- •Metastatic picture of line following the first
- •Technical or organizational inability to the eventual deadline for radiation treatments within 25 days of 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 without RT/SBRT combination
The patients will go to standard therapy (chemotherapy treatment with carboplatin-taxol or with drugs that the oncologist that the oncologist considers most useful.) without RT/SBRT combination
干预措施: Standard systemic therapy (chemotherapy) (Drug)
Standard systemic therapy with RT/SBRT combination
Standard systemic therapy (chemotherapy treatment with carboplatin-taxol or with drugs that the oncologist considers most useful) + combination of RT on the primary gastroesophageal Gross Tumor Volume (GTV) + SBRT on each of the distal lesions for oligometastatic or limited metastatic spread patients (to be delivered prior to initiation of systemic therapy).
干预措施: Radiation Therapy + standard sistemic therapy (chemoteraphy) (Radiation)
结局指标
主要结局
Disappearance of symptoms
时间窗: From the week after the treatment up to 12 months after
Percentage difference in the rate of patients with symptom (from primary tumor or metastasis) developed within the first 6 months.
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
CELLINI FRANCESCO
Clinical Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS