Registry for esophageal and gastroesophageal junction cancer
Prospective Registry Study of Multimodality Therapy for Oligometastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Memorial Sloan Kettering Cancer Center · NCT06558786
This study collects information from patients with newly diagnosed stage IV esophageal or gastroesophageal junction cancer to see how different treatments affect their quality of life and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06558786 on ClinicalTrials.gov |
What this trial studies
This registry collects data on patients with newly diagnosed stage IV adenocarcinoma of the esophagus or gastroesophageal junction cancer. The aim is to create a comprehensive database that helps researchers understand the effectiveness of various treatment options. Patients will be assessed using quality-of-life questionnaires to gather insights on their experiences and outcomes. The information gathered will contribute to improving treatment standards and patient care.
Who should consider this trial
Good fit: Ideal candidates are individuals newly diagnosed with stage IV adenocarcinoma of the esophagus or gastroesophageal junction with specific metastatic conditions.
Not a fit: Patients with earlier stages of esophageal cancer or those without the specified metastatic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of treatment effectiveness and improve quality of life for patients with esophageal and gastroesophageal junction cancer.
How similar studies have performed: Other studies utilizing registries for cancer treatment outcomes have shown success in improving patient care and treatment strategies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Daniela Molena, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Daniela Molena, MD
- Email: molenad@mskcc.org
- Phone: 212-639-3870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastroesophageal-junction Cancer, Esophageal Cancer, Quality-of-Life Assessments, 24-206