RECRUITING

Registry for Esophageal and Gastroesophageal Junction Cancer

Conditions

Gastroesophageal-junction Cancer Esophageal Cancer Quality-of-Life Assessments 24-206

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Registry Study of Multimodality Therapy for Oligometastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction

Quick Facts

Study Start:2024-08-12

Study Completion:2029-08-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06558786

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Daniela Molena, MD

CONTACT

212-639-3870

molenad@mskcc.org

Geoffrey Ku, MD

CONTACT

646-888-4588

Principal Investigator

Daniela Molena, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Daniela Molena, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-12

Study Completion Date2029-08-12

Study Record Updates

Study Start Date2024-08-12

Study Completion Date2029-08-12

Terms related to this study

Keywords Provided by Researchers

Quality-of-Life Assessments
24-206

Additional Relevant MeSH Terms

Gastroesophageal-junction Cancer
Esophageal Cancer