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Идёт набор NCT05704621

Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance

Фаза II С лечением Ovarian Cancer Drug Related Neoplasm/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: secondary cytoreductive surgery, chemotherapy.
Кому может быть актуально
Состояния в реестре: Ovarian Cancer, Drug Related Neoplasm/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
South Korea
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

A Randomized Phase II Study of Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance

Обзор

This is a randomized phase II study of secondary cytoreductive surgery (CRS) in patients with relapsed ovarian cancer who have progressed on PARP inhibitor maintenance.

Подробное описание

The primary objective is to find out whether the CRS is beneficial in patients who have progressed on PARPi maintenance.

Вмешательства

  • Процедура secondary cytoreductive surgery
    Maximum effort cytoreductive surgery
  • Препарат chemotherapy
    six cycles of platinum-based chemotherapy +/- bevacizumab

Первичные конечные точки

  • progression-free survival [Срок оценки: Up to 2 year]
Вторичные конечные точки (1)
  • Overall survival [Срок оценки: Up to 2 year]

Критерии участия

Критерии включения

  • Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage.
  • Progression-free interval of at least 6 months after end of last platinum- containing therapy,
  • Progressed during PARP inhibitor maintenance
  • Women aged ≥ 18 years
  • Complete resection of the tumor seems possible (estimated by an experienced surgeon). Intra-abdominal disease has to be excluded by MRI/CT, if other surgical approaches for isolated extra-abdominal recurrences are planned
  • A positive AGO-score or iMODEL+PET/CT
  • Patients who are likely to be completely resected according to the investigator's judgment will be allowed by consensus between PI(surgeon) and designated radiologist even if AGO or iMODEL+PET/CT negative.
  • Patients who have given their signed and written informed consent and their consent to data transmission and -processing.

Критерии исключения

  • Patients with non-epithelial tumors as well as borderline tumors.
  • Patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy
  • More than one prior chemotherapy
  • Patients with second, third, or later recurrence
  • Patients with second malignancies who have been treated by laparotomy, as well as other neoplasms, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.
  • Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former first platinum- containing therapy
  • Only palliative surgery planned
  • Radiological signs suggesting metastases not accessible to surgical removal (i.e. complete resection is deemed impossible)
  • Any concomitant disease not allowing surgery and/or chemotherapy
  • Any medical history indicating excessive peri-operative risk
  • Any current medication inducing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents, bevacizumab)
  • No assessable archival tumor tissue

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

South Korea · 1 центр
  • Severance Hospital — Seoul

Публикации

  • Cho HW, Kim HS, Park JY, Lee YY, Lim MC, Lee SJ, Min KJ, Eoh KJ, Lee KB, Kim MK, Song JY, Shim SH, Ji YI, Song YJ, Chang SJ, Kim MK, Abe A, Kobayashi Y, Kajiyama H, Shimada M, Okamoto A, Ng JS, Lee JY. A randomized phase II study of secondary cytoreductive surgery in patients with relapsed ovarian cancer who have progressed on a PARP inhibitor as first-line maintenance therapy: the SOCCER-P study PMID 39164041

Идентификаторы

NCT: NCT05704621 · KGOG3067/JGOG3036/APGOT-OV11

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗