Recruiting NCT06558786
Registry for Esophageal and Gastroesophageal Junction Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EORTC QLQ-C30 questionnaire, QLQ-OGS25 questionnaire.
- Who it may be relevant to
- Registry conditions: Gastroesophageal-junction Cancer, Esophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Registry Study of Multimodality Therapy for Oligometastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Overview
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.
Interventions
- Other 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) " - Other 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 d
Primary outcome measures
- Progression Free Survival [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
Identifiers
NCT: NCT06558786 · 24-206