💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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)
* Liver
* Lung
* 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 \[positive cytology\])
* Bone
* ≤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:
* Surgery
* Definitive chemoradiation
* Stereotactic radiation
* Ablation or similar techniques (e.g., irreversible electroporation)
* Age ≥18 years
Exclusion Criteria:
* 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
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