Registry for Esophageal and Gastroesophageal Junction Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Esophageal Cancer; Gastroesophageal-junction Cancer

Treatments: Other: EORTC QLQ-C30 questionnaire; Other: QLQ-OGS25 questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT06558786

24-206

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Esophageal and Gastroesophageal Junction Cancer

Description:

Patients will undergo assessment with the EORTC QLQ-C30 and QLQ-OGS25 questionnaires. Those patients who undergo local therapy will occur at baseline, months 7-9 within 45 days of local therapy, and one year/time of progression. Those patients who do not undergo local therapy will undergo assessment at baseline, at 6 months, and at one year.

Treatment:

Other: QLQ-OGS25 questionnaire

Other: EORTC QLQ-C30 questionnaire