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Идёт набор NCT05595603

Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage

Фаза II С лечением Giant Cell Tumor of Bone

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: 4mg ZOL loaded gentamicin PMMA, gentamicin PMMA.
Кому может быть актуально
Состояния в реестре: Giant Cell Tumor of Bone. Базовые параметры: Без ограничений · 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
Китай
Следующий шаг
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Официальное название

Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage: a Prospective, Multicenter, Single Blinded, Randomized Control Trial.

Обзор

The purpose of this study is to investigate whether zoledronic acid-loaded bone cement (4mg ZOL+ gentamicin PMMA ) as adjuvant method can decrease local recurrence in patients with giant cell bone tumor following intralesional curettage surgery. The hypothesis is that patients with local administration of zoledronic acid to the bone cement has lower relapse rate compared those with traditional bone cement(gentamicin PMMA ).

Подробное описание

The purpose of the clinical study is to investigate whether the local delivery of zoledronic acid (4mg ZOL-loaded gentamicin PMMA bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (GCT) of bone. The investigators will also evaluate whether patients with zoledronic acid as a surgical adjuvant improves secondary outcomes, including function (MSTS and TESS), surgery related complications (henderson's failure mode) and ZOL-related complications.

Вмешательства

  • Процедура 4mg ZOL loaded gentamicin PMMA
    During surgery, 4mg ZOL will be mixed with gentamicin (1000mg) PMMA cement (40g) by surgeon under sterile conditions to prepare ZOL loaded bone cement, and then it will be filled into the bony defects of the patient where the lesion has been removed after intralesional curettage.
  • Процедура gentamicin PMMA
    During surgery, gentamicin (1000mg) PMMA (40g) was prepared by surgeon under sterile conditions and will be filled into the bony defects of the patient where the lesion has been removed after intralesional curettage.

Первичные конечные точки

  • time to first local recurrence [Срок оценки: All patients will be followed for this endpoint until 18 months postoperatively]
Вторичные конечные точки (4)
  • MSTS score [Срок оценки: Doctors will be responsible in filling this questionnaire 3 months, 9 months, 12 months, 18 months postoperatively during patients' follow up]
  • TESS score [Срок оценки: Patients will be asked to fill this survey 3 months, 9 months, 12 months, 18 months postoperatively]
  • postoperative complication [Срок оценки: Patients will be asked to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively during follow up]
  • Potential ZOL-related complications [Срок оценки: Patients will be followed to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively.]

Критерии участия

Критерии включения

  • patients with primary resectable GCT of bone
  • lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal
  • no previous systemic bisphosphonate or denosumab therapy
  • with expected longer than 18 months of survival time
  • sign the informed consent form

Критерии исключения

  • patients with recurrent GCT or extensive GCT which is impossible or inappropriate to use curettage surgery due to its "unresectable" nature.
  • conduct unexpected surgery at other center
  • the primary goal for surgery is revision
  • patient conduct en-bloc/wide resection instead of curettage surgery
  • patient can not conduct self-assessment during follow up
  • difficulty in complete postoperative follow-up
  • previous use of bisphosphonate/ZOL or denosumab drug
  • patients have participated in similar research projects
  • refused to sign informed consent

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
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The Second Affiliated Hospital of Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT05595603 · 2022_LM1020

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗