NCT06558786 Registry for Esophageal and Gastroesophageal Junction Cancer
| NCT ID | NCT06558786 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Gastroesophageal-junction Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-08-12 |
| Primary Completion | 2029-08-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-08-12 with a primary completion date of 2029-08-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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) * 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
Contact & Investigator
Daniela Molena, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT06558786 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastroesophageal-junction Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06558786 currently recruiting?
Yes, NCT06558786 is actively recruiting participants. Contact the research team at molenad@mskcc.org for enrollment information.
Where is the NCT06558786 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06558786 clinical trial?
NCT06558786 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Daniela Molena, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 50 participants.
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