What this study is
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.
What's being tested
- EORTC QLQ-C30 questionnaire
Intervention · OTHER
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
Intervention · OTHER
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.
Study details
- Official title
- Prospective Registry Study of Multimodality Therapy for Oligometastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Gastroesophageal-junction Cancer · Esophageal Cancer
- Enrolling
- 50 people
- Starts
- 2024-08-12
- Est. completion
- 2029-08-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMemorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
- Daniela Molena, MD · Contact212-639-3870
Recruiting
Study team
Sponsor
Memorial Sloan Kettering Cancer Center
Study ID 24-206
Principal investigator
Daniela Molena, MD
Memorial Sloan Kettering Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.