NCT06558786招募中不适用
Prospective Registry Study of Multimodality Therapy for Oligometastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this registry study is to create a database-a collection of information-for better understanding standard treatments for esophageal and Gastroesophageal Junction Cancer/GEJ cancer. Researchers will use the information from this database to learn more about the effectiveness of different treatment options.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Newly diagnosed stage IV adenocarcinoma of the esophagus or GEJ with OMD at the time of diagnosis, defined as the following:
- •Retroperitoneal lymph nodes (e.g., para-aortal, intra-aorto-caval, parapancreatic, or mesenterial lymph node)
- •Extra-abdominal lymph nodes (e.g., supraclavicular or cervical lymph nodes)
- •Adrenal gland
- •Unilateral or bilateral ovarian metastases (in the absence of gross or microscopic peritoneal disease [positive cytology])
- •≤2 sites of disease (excluding the primary tumor and regional lymph nodes)
- •≤3 tumors within each organ system
- •≤5 metastases
- •All nonregional lymph nodes (including cervical, supraclavicular, and retroperitoneal nodal disease) are considered 1 discrete lesion
- •Satellite lesions in the primary esophageal malignancy, such as skipped esophageal primaries, are not considered metastatic sites
- •All sites of disease must be amenable to complete local therapy after systemic therapy, according to the treating physician. Treatment modalities include:
- •Definitive chemoradiation
- •Stereotactic radiation
- •Ablation or similar techniques (e.g., irreversible electroporation)
- •Age ≥18 years
排除标准
- •Presence of metastases, at the time of diagnosis, to the following:
- •Peritoneum, including positive peritoneal lavage (on the basis of baseline diagnostic laparoscopy to rule out gross disease and positive peritoneal lavage cytology; laparoscopy may be omitted for patients in whom all sites of disease are above the diaphragm)
- •Malignant pleural effusion
- •Brain metastases or leptomeningeal disease
- •Other sites not specifically noted must be reviewed and approved by the PIs
- •Any site of disease that is not amenable to definitive local therapy
- •Unfit for best systemic therapy
- •Metachronous OMD
- •Secondary primary cancer, with the exclusion of basal cell carcinoma of the skin
- •Pregnant, lactating, or intending to become pregnant
- •Unwilling to provide informed consent
结局指标
主要结局
Progression Free Survival
时间窗: 1 year
Estimate 12-month PFS among patients who undergo definitive local therapy after induction chemotherapy
次要结局
未报告次要终点
研究者
研究点 (1)
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