Prospective Registry Study of Multimodality Therapy for Oligometastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction

Memorial Sloan Kettering Cancer Center1 site in 1 country50 target enrollmentAugust 12, 2024

ConditionsGastroesophageal-junction Cancer Esophageal Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Gastroesophageal-junction Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 50
Locations: 1
Primary Endpoint: Progression Free Survival
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 12, 2024

End Date

August 12, 2029

Last Updated

11 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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)
•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

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