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Registry for Esophageal and Gastroesophageal Junction Cancer
RECRUITINGSponsored by Memorial Sloan Kettering Cancer Center
Actively Recruiting
SponsorMemorial Sloan Kettering Cancer Center
Started2024-08-12
Est. completion2029-08-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06558786
Summary
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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
Conditions3
CancerEsophageal CancerGastroesophageal-junction Cancer
Locations1 site
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Daniela Molena, MD212-639-3870
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Actively Recruiting
SponsorMemorial Sloan Kettering Cancer Center
Started2024-08-12
Est. completion2029-08-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06558786