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Идёт набор NCT06677112

MCC-24-GYN-11: Comparison of Nodal Sampling in Endometrial Cancer

Без фазы С лечением Endometrial 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: Selective surgical staging, REFLEX.
Кому может быть актуально
Состояния в реестре: Endometrial Cancer. Базовые параметры: от 18 лет · Женщины.
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

Randomized Phase 3 Study of SELECTIVE SURGICAL STAGING Versus REFLEX Lymphadenectomy in Non-mappers Undergoing Sentinel Lymph Node Sampling for the Treatment of Endometrial Cancer

Обзор

This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging. This study will gather information to help determine the best way to evaluate lymph nodes during surgery for endometrial cancer.

Вмешательства

  • Процедура Selective surgical staging
    Intraoperative Consultation, performed by pathologist and surgeon jointly. The uterus is inspected for extra-corpus spread (cervix, parametria, adnexa, distant). The surgical pathologist will evaluate the uterus according to the IOC Worksheet and promptly notify the surgeon of the results. The IOC will include evaluation for extra-corpus disease, lesion measurement, frozen section (to confirm measured lesion is malignant, cell type, and re-grading of tumor). Non-sentinel nodes will be handled ac
  • Процедура REFLEX
    The surgeon will perform a side-specific lymphadenectomy when there is no mapping on a hemipelvis (no tracer uptake in nodes). If neither side has successful Sentinel Node mapping, the surgeon performs a complete pelvic lymphadenectomy. Surgeons will remove the para-aortic lymph nodes at their discretion.

Первичные конечные точки

  • Recurrence free survival [Срок оценки: up to 5 years]
Вторичные конечные точки (4)
  • Concordance between selective surgical staging and final pathology Incidence [Срок оценки: 5 years]
  • Progression-free survival [Срок оценки: up to 5 years]
  • Disease-specific Survival [Срок оценки: up to 5 years]
  • Overall patient survival rate [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Surgical candidate for complete hysterectomy and bilateral salpingooophorectomy with pelvic and aortic lymphadenectomy
  • Histologically or cytologically confirmed carcinoma of the endometrium confined to the uterine corpus
  • No clinical evidence of extra-uterine disease on pre-operative evaluation. Preoperative evaluation to rule-out extra-uterine disease may include a CT scan, MRI or ultrasound. Note: preoperative imaging is not mandatory for study enrollment.
  • Prior systemic chemotherapy is allowed so long as it was at least five years prior to study enrollment, and there is no evidence of disease after such therapy.

Neoadjuvant chemotherapy for this endometrial cancer is not allowed.

  • Life expectancy (estimated survival) of at least 6 months.
  • AST(SGOT)/ALT(SGPT) < 3.0X upper limit of normal
  • Ability to understand and the willingness to sign a written informed consent document

Критерии исключения

  • GOG Performance Status greater than 2 (Appendix II)
  • Uterine sarcoma
  • Clinical evidence of disease that extends beyond the uterus, including the presence of suspicious aortic or inguinal nodes on imaging or clinical exam
  • Previous vaginal, pelvic or abdominal irradiation
  • Chemotherapy or immunotherapy directed at the present disease
  • Previous pelvic lymphadenectomy or retroperitoneal surgery
  • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen should be excluded
  • Known allergy to iodine or indocyanine green (ICG) tracer, or allergic reactions to compounds of similar chemical or biologic composition
  • Patients with uncontrolled intercurrent illness
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or lactating women. Women of child-bearing potential will be excluded if they have a positive serum/urine pregnancy test

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Kentucky — Lexington

Идентификаторы

NCT: NCT06677112 · 98450

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗