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Recruiting

NCT Number: NCT06558786

Registry for Esophageal and Gastroesophageal Junction Cancer

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, 10065, United States

Location status: Recruiting

Location contact

Daniela Molena, MD

CONTACT

212-639-3870

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Progression Free Survival

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Molena, MD

CONTACT

[email protected]

212-639-3870

Geoffrey Ku, MD

CONTACT

646-888-4588

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Prospective Registry Study of Multimodality Therapy for Oligometastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Aug 19, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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