Clinical trial NCT06558786: Registry for Esophageal and Gastroesophageal Junction Cancer
Official title: Prospective Registry Study of Multimodality Therapy for Oligometastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastroesophageal-junction Cancer
Esophageal Cancer
Keywords: Quality-of-Life Assessments
24-206
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at MSK.

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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Daniela Molena, MD
role: PRINCIPAL_INVESTIGATOR
References: