RecruitingNCT06558786

Registry for Esophageal and Gastroesophageal Junction Cancer

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

50 participants

Start Date

Aug 12, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry study is collecting data from patients with newly diagnosed Stage IV esophageal or gastroesophageal junction (GEJ) cancer that has spread to a limited number of sites (called oligometastatic disease). The goal is to understand how these patients do when all areas of disease are treated aggressively with both systemic therapy and local treatments like surgery or radiation. **You may be eligible if...** - You are 18 or older with a new diagnosis of Stage IV esophageal or GEJ adenocarcinoma - Your cancer has spread to 5 or fewer metastatic sites in 2 or fewer organ systems (limited spread) - All sites of disease appear to be treatable with local therapies after systemic treatment - Eligible metastatic sites include: liver, lung, lymph nodes, bone, adrenal glands, or ovaries **You may NOT be eligible if...** - Your cancer has spread to the lining of the abdomen (peritoneum) or has positive peritoneal washings - You have spread to the brain or bone marrow - You have more than 5 metastases or spread to more than 2 organ systems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREORTC 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.

OTHERQLQ-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.


Locations(1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

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NCT06558786


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