Registry for Esophageal and Gastroesophageal Junction Cancer
- Conditions
- Gastroesophageal-junction CancerEsophageal Cancer
- Interventions
- Other: EORTC QLQ-C30 questionnaireOther: QLQ-OGS25 questionnaire
- Registration Number
- NCT06558786
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Esophageal and Gastroesophageal Junction Cancer EORTC QLQ-C30 questionnaire 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. Esophageal and Gastroesophageal Junction Cancer QLQ-OGS25 questionnaire 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.
- Primary Outcome Measures
Name Time Method Progression Free Survival 1 year Estimate 12-month PFS among patients who undergo definitive local therapy after induction chemotherapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
🇺🇸New York, New York, United States