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Идёт набор NCT07022535

Personalised Timing of Interval Debulking Surgery in Advanced Ovarian Cancer

Фаза II С лечением Ovarian Cancer Fallopian Tube Cancer Peritoneal 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: KELIM, Carboplatin plus Paclitaxel, Interval debulking surgery.
Кому может быть актуально
Состояния в реестре: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal 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
Гонконг
Следующий шаг
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Официальное название

Personalised Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Pilot Study

Обзор

About 70% of epithelial ovarian cancer patients are diagnosed at advanced stage. When primary optimal surgery is not possible, neoadjuvant chemotherapy will followed by interval debulking surgery is one treatment option. However, there is no consensus on the optimal timing of the surgery. CA125 is a well-known tumor marker in ovarian cancer. Its kinetic change has been proven to correlate with the patients' response to chemotherapy and chance of optimal resection. This study aims to utilize the kinetic change of CA125 to customize the timing of surgery for individual patients.

Подробное описание

Recruited patients will have additional CA125 at 4th (before administration of chemotherapy), and 5th week after the first cycle of chemotherapy. CA-125 ELIMination Rate Constant K (KELIM) will be determined. Patients with KELIM =\>1 will receive radiological assessment and undergo internal debulking surgery if the disease is operable. Patients with KELIM \<1 will have alternative management, such as addition of bevacizumab or changing to dose-dense chemotherapy, and defer the interval debulking surgery

Вмешательства

  • Диагностический тест KELIM
    (i) Patients with KELIM \>=1 will receive radiological assessment and undergo interval debulking surgery if the disease is operable. (ii) Patients with KELIM \<1 will have alternative management, such as addition of bevacizumab or changing to dose-dense chemotherapy, and defer the interval debulking surgery
  • Препарат Carboplatin plus Paclitaxel
    Chemotherapy as neaodjuvant chemotherapy
  • Процедура Interval debulking surgery
    Interval debulking surgery

Первичные конечные точки

  • Complete resection (CC0) rate [Срок оценки: Up to 24 months]
  • Sensitivity of KELIM in predicting CC0 [Срок оценки: Up to 24 weeks]
Вторичные конечные точки (3)
  • Time required to achieve KELIM >=1 [Срок оценки: Up to 24 weeks]
  • Complication rates of treatment [Срок оценки: Up to 1 year]
  • Quality-of-life scale [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

  • Patients must be at least 18 years old.
  • Patients who have Eastern Cooperative Oncology Group (ECOG) score 0-1.
  • Patients who are competent to give informed consent.
  • Patients who have stage III-IV histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer not amenable for primary debulking surgery (PDS).
  • Patients who are planned for neoadjuvant chemotherapy (NACT) using platinum-based chemotherapy +/- bevacizumab or biosimilar. Those who are receiving NACT before interval debulking surgery (IDS) are also eligible.
  • Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal).
  • Patients who have baseline computed tomography of at least abdomen and pelvis, or positron emission tomography (PET)-CT. Magnetic resonance imaging (MRI) is also acceptable but the same modality has to be used when assessing the feasibility of IDS.
  • Patients who agree to undergo IDS, where the time of IDS may differ from the usual clinical practice.
  • Patients who agree to receive adjuvant chemotherapy, if clinically indicated. The total number of chemotherapy should be at least four or above.

Критерии исключения

  • Patients who have borderline malignancy, or non-epithelial ovarian cancer like germ cell or sex cord tumor, or metastatic diseases from other origins like Krukenberg's tumor
  • Patients who are eligible for PDS
  • Patients who are not fit for PDS because of medical morbidities or refusal of operation
  • Patients who have already started NACT outside the study centres, except those who have just had one cycle within 21 days and the baseline CA125 is available.
  • Patients who are pregnant

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

Гонконг · 1 центр
  • The University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT07022535 · UW 24-304 · HKUCTR-3091

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗