Registry for Esophageal and Gastroesophageal Junction Cancer

NCT ID: NCT06558786

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-12
• Study Completion Date: 2029-08-12

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.

Conditions

Gastroesophageal-junction Cancer; Esophageal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Esophageal and Gastroesophageal Junction Cancer

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.

EORTC QLQ-C30 questionnaire

Intervention Type: 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 Type: 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.

Interventions

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) "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.

Intervention Type: 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 deterioration of symptoms.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniela Molena, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniela Molena, MD

Role: CONTACT

molenad@mskcc.org

212-639-3870

Geoffrey Ku, MD

Role: CONTACT

646-888-4588

Facility Contacts

Daniela Molena, MD

Role: primary

212-639-3870

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

24-206

Identifier Type: -

Identifier Source: org_study_id