Registry for Esophageal and Gastroesophageal Junction Cancer

Recruiting

• Conditions: Gastroesophageal-junction Cancer; Esophageal Cancer

• Registration Number: NCT06558786
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-12
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-15
• Study First Posted: 2024-08-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2029-08-12
• Study Completion: 2029-08-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	1 year	Estimate 12-month PFS among patients who undergo definitive local therapy after induction chemotherapy

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States