NCT06558786Recruiting
Registry for Esophageal and Gastroesophageal Junction Cancer
Memorial Sloan Kettering Cancer Center
Start Date
8/12/2024
Completion Date
8/12/2029
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 Criteria
Age Range: 18 years to No maximum
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
Interventions
OTHER
EORTC QLQ-C30 questionnaire
OTHER
QLQ-OGS25 questionnaire
Conditions
Gastroesophageal-junction CancerEsophageal Cancer
Locations
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United States