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Идёт набор NCT05123807

Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)

Фаза II С лечением Ovarian 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: Cytoreductive surgery.
Кому может быть актуально
Состояния в реестре: Ovarian 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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Обзор

The primary objective is to estimate overall survival after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer

Подробное описание

PRIMARY OBJECTIVE:

The primary objective is to estimate progression-free survival (PFS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer

SECONDARY OBJECTIVES:

* To estimate overall survival (OS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer * To evaluate toxicity and morbidity of secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer * To estimate quality of life after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer * To estimate what proportion of patients who preoperatively appear to be candidates for secondary cytoreductive surgery and HIPEC are found to have unresectable disease at time of surgical exploration * To collect blood and tumor samples for biobanking to be used for exploratory endpoints

Вмешательства

  • Другое Cytoreductive surgery
    (an operation to remove as much tumor tissue as possible) with hyperthermic intraperitoneal chemotherapy

Первичные конечные точки

  • To estimate progression-free survival (PFS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer [Срок оценки: through study completion, an average of 6 years (patients will be followed for 6 years after treatment completion]

Критерии участия

Критерии включения

  • Patients must have histologically or cytologically confirmed recurrent primary mucinous ovarian cancer
  • Age ≥18 years
  • ECOG performance status ≤ 2
  • Prior to surgery, patients must have adequate organ and marrow function as defined below (within 30 days of registration):
  • absolute neutrophil count >1,500/mcL
  • platelets >100,000/mcL
  • total bilirubin ≤ 1.5 mg/dL
  • creatinine ≤ 1.5 mg/dL
  • AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal
  • Patients must be > 2 weeks from prior chemotherapy or radiation therapy, except for bevacizumab treatment which requires >6 weeks
  • Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)

Критерии исключения

  • Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of HIPEC (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
  • Patients with mucinous tumors with pathologic confirmation of a non-gynecologic site of origin
  • Patients with known active CNS metastases
  • Patients with known hypersensitivity to any of the components of cisplatin
  • Patients with a prior or concurrent malignancy who natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Women who are pregnant or nursing women
  • Patients with peripheral neuropathy ≥ grade 2
  • History of allogenic transplant
  • History of prior HIPEC or intraperitoneal chemotherapy
  • Known bulky extra-abdominopelvic disease
  • Patients with hearing impairment/tinnitus ≥ grade 2

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT05123807 · 2021-0660 · NCI-2021-12842

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗