Registry for Esophageal and Gastroesophageal Junction Cancer

NCT06558786 | Recruiting

• 1 other identifier: 24-206
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Quality-of-Life Assessments; 24-206

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Estimate 12-month PFS among patients who undergo definitive local therapy after induction chemotherapy

  1 year

Study Arms (1)

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.

Other: EORTC QLQ-C30 questionnaire; Other: QLQ-OGS25 questionnaire

Interventions

EORTC QLQ-C30 questionnaire 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.

Esophageal and Gastroesophageal Junction Cancer

QLQ-OGS25 questionnaire 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.

Esophageal and Gastroesophageal Junction Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You 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

You may not qualify 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
• Pregnant, lactating, or intending to become pregnant
• Unwilling to provide informed consent

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Daniela Molena, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Molena, MD

CONTACT

212-639-3870; molenad@mskcc.org

Geoffrey Ku, MD

CONTACT

646-888-4588

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 19, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): August 12, 2029
• Study Completion (Estimated): August 12, 2029
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)