En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.

Официальное название

En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor-A Multi-center, Prospective, Randomized, Controlled Study.

Обзор

The purpose of this clinical trial is to explore the impact of En bloc surgery and separation surgery combined with radiation therapy on the prognosis and survival of patients with spinal oligometastatic cancer, describe the clinical results, and optimize future treatment goals

Подробное описание

Patients with oligometastatic diseases have been shown to have better prognosis than those with multiple metastatic diseases, and some patients have achieved long-term survival, thus being considered to benefit from more aggressive treatment. Active local treatment, including surgery and/or targeted radiotherapy, such as Stereotactic Radiosurgery (SRS) and Stereotactic body radiotherapy (SBRT), can be performed before or after systemic treatment. For both primary and oligometastatic tumors, radical treatment should be considered in order to achieve better survival and prognosis. The current research has explored the different effects of oligometastatic disease status on the prognosis of various cancers. However, there is currently no clear clinical or experimental confirmation of the impact on the survival and treatment outcomes of patients with oligometastatic spinal cancer. The purpose of this clinical trial is to explore the impact of En bloc hand surgery and separation surgery combined with radiotherapy on the prognosis and survival of patients with oligometastatic spinal cancer, Describe clinical outcomes and optimize future treatment goals

Вмешательства

• Процедура total en bloc spondylectomy
  Total enbloc resection (TES) is one of the most challenging surgeries in spinal surgery and a classic surgical method. It not only relieve spinal cord compression and delays tumor recurrence, but also prolongs patient survival, significantly reduces hand surgery trauma, and improves surgical safety. However, for cases with extensive tumor invasion, methods such as separation surgery should be used to relieve spinal cord nerve compression, rebuild spinal stability, and provide conditions for post

Первичные конечные точки

• Overall Survival(OS) [Срок оценки: after surgery until death due to primary disease or responsible segment]

Вторичные конечные точки (5)

• Local Control Rate(LRC) [Срок оценки: a 20% increase in the total diameter of the target lesion observed on imaging from the beginning of the patient's current treatment to baseline.]
• Progression-Free Survival(PFS) [Срок оценки: The period between the patient receiving this treatment and observing local progression or death from any cause.]
• Brief Pain inventory [Срок оценки: 1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery.]
• EORTC Quality of Life Questionnaire - Core 30 [Срок оценки: 1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery]
• Complication [Срок оценки: 1 month, 3 months, 6 months, and 12 months after surgery.]

Критерии участия

Критерии включения

• 1\) Be able to sign written informed consent.
• 2\) Age range from 18 to 75 years old, regardless of gender.
• 3\) Within conservative treatment, the patient still has uncontrollable pain, metastatic cancer lesions that still progress, spinal instability/potential instability, or symptoms of spinal cord/nerve compression.
• 4\) After the patient underwent Positron Emission Tomography-Computed Tomography (PET-CT) examination, it was indicated that there were no more than 3 metastatic organs and no more than 5 metastatic lesions in the whole body of cancer. Among them, there was at least 1 spinal metastasis and at most 5 spinal metastases.
• 5\) Imaging examinations (enhanced MRI, enhanced CT, X-ray) indicate the presence of spinal metastasis.
• 6\) The expected survival period is ≥ 6 months.
• 7)No other surgical contraindications

Критерии исключения

• 1\) Primary tumors of the spine or multiple tumors of the body, with>3 metastatic organs and>5 metastatic sites.
• 2\) Previously underwent spinal surgery, or received radiotherapy for the responsible segment of this treatment.
• 3\) Severe heart, lung, liver, kidney or other diseases affecting the surgery.
• 4\) Having cognitive impairment, sensory aphasia, and inability to understand basic instructions.
• 5\) Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment.
• 6\) Infectious diseases.
• 7\) Refuse to follow up or participate.
• 8\) The researchers determine that the patients are not suitable for enrollment this clinical trail.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Shanghai Changzheng hospital — Шанхай

Публикации

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Идентификаторы

NCT: NCT06120426 · 2023SL050

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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