Status:
RECRUITING
Registry for Esophageal and Gastroesophageal Junction Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Gastroesophageal-junction Cancer
Esophageal Cancer
Eligibility:
All Genders
18+ years
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. Rese...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 12 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 12 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06558786
Start Date
August 12 2024
End Date
August 12 2029
Last Update
May 22 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065