Single High-dose Brachytherapy for Giant Osteosarcoma Masses

Официальное название

The Therapeutic Effect of Single High-dose Brachytherapy for Locally Inoperable and Metastatic Giant Osteosarcoma Masses

Обзор

This study is a prospective, single-arm, phase II, single-center study. Patients with locally unresectable giant osteosarcoma masses who meet the criteria are enrolled in the experimental group, and all patients receive a single dose of 10Gy of implantable brachytherapy. Record treatment-related acute events during and after treatment. Follow up on survival and local control after treatment ends, marking the end of the trial treatment.

Подробное описание

Screening period: Local MRI or CT examination, blood routine and coagulation function test.

Selected treatment period: All enrolled patients received one dose of close range interstitial radiotherapy with a radiation dose of 10 Gy. The number of insertion needles depends on the size and location of the tumor. The instrument used for radiotherapy is the Medda high-dose rate brachytherapy machine, and the radiation source is 192 iridium. Record treatment related acute events such as bleeding during the treatment period.

Follow up: Follow up with local MRI or CT at 1 month, 3 months, 6 months, and 1 year after the end of radiotherapy treatment to evaluate the treatment effect; Simultaneously follow up with patients for survival and treatment related adverse reactions, such as dermatitis, infections, etc.

Вмешательства

• Лучевая терапия brachytherapy
  Patients with locally unresectable giant osteosarcoma masses who meet the criteria are enrolled in the experimental group, and all patients receive a single dose of 10Gy of implantable brachytherapy. Record treatment-related acute events during and after treatment. Follow up on survival and local control after treatment ends, marking the end of the trial treatment.

Первичные конечные точки

• progression-free survival [Срок оценки: 6 months]

Вторичные конечные точки (4)

• progression-free survival [Срок оценки: 12 months]
• progression-free survival [Срок оценки: 12 months]
• OS [Срок оценки: 12 months]
• Adverse reactions related to radiotherapy [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Pathological diagnosis of osteosarcoma;
• Age range 12-70 years old;
• The primary or metastatic lesion cannot be surgically removed based on clinical evaluation, and treatment with internal medicine multi line chemotherapy, targeted therapy, immunotherapy, etc. is ineffective;
• ECOG physical fitness status is 0-1 points;
• According to RECIST version 1.1 standard, there must be at least one evaluable target lesion with a mass length diameter greater than 5cm;
• Sign a written informed consent form before conducting any experimental activities;
• Researchers determine that they are able to comply with the research protocol;
• Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests, and other research procedures.

Критерии исключения

• Local mass previously received radiation therapy;
• Major surgery ≤ 4 weeks before enrollment;
• Previous or concurrent malignant tumors (excluding malignant tumors that have been cured and have a cancer free survival of more than 5 years, such as basal cell carcinoma of the skin and papillary thyroid carcinoma);
• Pregnant or lactating women;
• Active pulmonary tuberculosis.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06524778 · CSH06R102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗