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Идёт набор NCT06558786

Registry for Esophageal and Gastroesophageal Junction Cancer

— Наблюдательное Gastroesophageal-junction Cancer Esophageal Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: EORTC QLQ-C30 questionnaire, QLQ-OGS25 questionnaire.
Кому может быть актуально
Состояния в реестре: Gastroesophageal-junction Cancer, Esophageal Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Другое 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) "
  • Другое 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 d

Первичные конечные точки

  • Progression Free Survival [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York

Идентификаторы

NCT: NCT06558786 · 24-206

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗