Registry for Esophageal and Gastroesophageal Junction Cancer

Trial Title: Registry for Esophageal and Gastroesophageal Junction Cancer

NCT ID: NCT06558786

Condition: Gastroesophageal-junction Cancer
Esophageal Cancer

Conditions: Keywords:
Quality-of-Life Assessments
24-206

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: EORTC QLQ-C30 questionnaire
Description: 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.
Arm group label: Esophageal and Gastroesophageal Junction Cancer

Intervention type: Other
Intervention name: QLQ-OGS25 questionnaire
Description: 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.
Arm group label: Esophageal and Gastroesophageal Junction Cancer

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.

Criteria for eligibility:

Study pop:
Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at MSK.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Contact:
Last name: Daniela Molena, MD

Phone: 212-639-3870

Start date: August 12, 2024

Completion date: August 12, 2029

Lead sponsor:
Agency: Memorial Sloan Kettering Cancer Center
Agency class: Other

Source: Memorial Sloan Kettering Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06558786
http://www.mskcc.org/mskcc/html/44.cfm