Esophageal Cancer, Gastroesophageal-junction Cancer
Conditions
Keywords
Quality-of-Life Assessments, 24-206
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.
Interventions
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 1 year | Estimate 12-month PFS among patients who undergo definitive local therapy after induction chemotherapy |
Countries
United States
Contacts
CONTACTDaniela Molena, MD
CONTACTGeoffrey Ku, MD
PRINCIPAL_INVESTIGATORDaniela Molena, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed