Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06558786

Conditions

Gastroesophageal-junction Cancer

Esophageal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EORTC QLQ-C30 questionnaire

QLQ-OGS25 questionnaire

Study Details

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.

Conditions

Gastroesophageal-junction Cancer

Esophageal Cancer

Study ID

NCT06558786

Start date

Aug 12, 2024

Status verified date

May, 2026

Completion date

Aug 12, 2029

Anticipated

Primary completion date

Aug 12, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Esophageal and Gastroesophageal Junction Cancer

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.

Interventions

EORTC QLQ-C30 questionnaire

The EORTC QLQ-C30 has 30 items arranged into 9 scales and 6 single items. The scales are divided into 5 function scales (physical, role, cognitive, emotional, and social function), 3 symptom scales (fatigue, pain, and nausea or vomiting), and 1 global health status/quality-of-life scale. The 6 single items address specific symptoms (dyspnea, appetite loss, insomnia, constipation, and diarrhea) and the financial impact of the disease. Each item has 4 response alternatives: (1) "not at all," (2) "a little," (3) "quite a bit," and (4) "very much," except for the global health status/quality-of-life scale, which has response options ranging from (1) "very poor" to (7) "excellent." For analysis, all questionnaire responses will be transformed into scores on a linear scale of 0 to 100 in accordance with the EORTC scoring manual. Mean scores with standard deviations will be calculated, with a higher score indicating a better health-related quality of life.

QLQ-OGS25 questionnaire

The QLQ-OGS25 is specific for esophageal, GEJ, or gastric cancer and consists of a symptom scale only. The QLQ-OGS25 has 6 scales: dysphagia, eating restrictions, reflux, odynophagia, pain, and anxiety. Scales have good reliability (α range, 0.67-0.87), and they distinguish between tumor sites and disease stage. The response format is a 4-point Likert scale. Responses to the questionnaires will be transformed into a scale of 0 to 100 using the EORTC guidelines, with a higher score indicating a deterioration of symptoms.

Primary outcome measure

  • Progression Free Survival [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Daniela Molena, MD

212-639-3870molenad@mskcc.org

Geoffrey Ku, MD

646-888-4588

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Daniela Molena, MD

212-639-3870

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Quality-of-Life Assessments
  • 24-206

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-22.