Идёт набор NCT07538024

Pilot Randomized Study for Treatment Volume De-Escalation for Spinal Metastases With Stereotactic Body Radiation Therapy

Без фазы С лечением Metastases to 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: Stereotactic Body Radiation Therapy (SBRT) in control arm, Stereotactic Body Radiation Therapy (SBRT) in experimental arm.
Кому может быть актуально: Состояния в реестре: Metastases to Bone. Базовые параметры: от 18 лет · 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: Италия
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, Pilot Study on tREatment VOLume De-escalation for SPINal mEtastases SBRT (REVOL-SPINE)

Обзор

A single centre, non-profit, randomised, unblinded pilot study on volume definition for spinal stereotactic body radiation therapy treatment. Randomization will be 1:1 between two types of SBRT treatment for spinal metastases. The statistical unit will be the individual vertebral metastasis. Multiple metastases will be randomized and evaluated independently.

Подробное описание

Patients with spinal oligometastases who will be evaluated for SBRT will have to sign informed consent before any study-related procedure. Afterwards, a simulation computed tomography (CT) will be performed, and the metastases will be randomized to:

* Control arm: volume definition according to Cox contouring guidelines * Experimental arm: volume definition based on the pathological lesion at Magnetic Resonance Imaging (MRI).

The treatment will be delivered at the center in either three or five fractions.

The planned follow-up consists of routine visits and exams, as per common clinical practice, according to primary histology (including an MRI to evaluate response of the vertebral lesion treated) at 3 months, 6 months, and subsequently every 6 months until the 2-year follow-up period. During these visits, physicians will assess the adverse events and NRS (a unidimensional measure of pain intensity in adults, from 0 to 10, and the result will be compared to the baseline).

The gross tumor volume (GTV) will be defined by MRI and PET uptake, if available, and the simulation CT. The treatment volume will be delineated based on MRI coregistered with the planning CT. The MRI protocol will include T1, T2-weighted, and diffusion-weighted imaging (DWI) sequences. The Planning Target Volume (PTV) will be obtained by adding an isotropic margin of 2 mm from the GTV, avoiding the spinal canal.

The clinical target volume (CTV) will be defined by the vertebral region according to the Cox contouring guidelines, and the PTV will be obtained by adding an isotropic margin of 2 mm from the CTV, avoiding the spinal canal.

Radiotherapy dose:

According to the current guidelines, available fractionations are 30 Gy in 3 fractions or 35 Gy in 5 fractions.

Planning:

The plan evaluation ensures at least 95% of the prescribed dose to 95% of the PTV without exceeding 120% of the prescribed dose. A partial PTV uncovering will be accepted if necessary to preserve mandatory constraints to OARs, considering a minor deviation if 95% of the PTV receives 85% or more of the prescribed dose, and a major deviation if 95% of the PTV receives less than 85% of the prescribed dose. Any deviation will be recorded but will not impact the patient's participation in the study.

Вмешательства

Лучевая терапия Stereotactic Body Radiation Therapy (SBRT) in control arm
Stereotactic Body Radiation Therapy performed in vertebral metastases with volume definition according to Cox contouring guidelines. The treatment will be delivered at the participating center in either three or five fractions. The planned follow-up consists of routine visits and exams as per common clinical practice, according to primary histology (including an MRI to evaluate response of the vertebral lesion treated) at 3 months, 6 months, and subsequently every 6 months until the 2-year follo
Лучевая терапия Stereotactic Body Radiation Therapy (SBRT) in experimental arm
Stereotactic Body Radiation Therapy performed in vertebral metastases with volume definition based on the pathological lesion at MRI. The treatment will be delivered at the participating center in either three or five fractions. The planned follow-up consists of routine visits and exams as per common clinical practice, according to primary histology (including an MRI to evaluate response of the vertebral lesion treated) at 3 months, 6 months, and subsequently every 6 months until the 2-year foll

Первичные конечные точки

2-years local progression-free survival [Срок оценки: At 2 years from enrollment]

Вторичные конечные точки (2)

Local progression-free survival at 3, 6, 12 and 18 months [Срок оценки: At 3, 6, 12 and 18 months from the enrollment]
Adverse events; progression on a new vertebral segment; pain relief and pseudoprogression [Срок оценки: At 3, 6, 12, 18 and 24 months from enrollment]

Критерии участия

Критерии включения

Patients affected by spinal metastases eligible for SBRT
All histologies are allowed
Oligometastatic disease (maximum 5 metastases) in every setting (oligopersistent, oligorecurrent and oligoprogressive, according to ESTRO consensus)
Metastases treated with ablative intent
Both symptomatic and asymptomatic vertebral metastases
Spine Instability Neoplastic Score (SINS) score < 7 \[18\]
Age > 18 years
Life expectancy > 12 months
PS ECOG 0-1
Vertebral pathological lesion on the diagnostic MRI
Single active lesion on the target vertebra
More lesions in different vertebrae can be simultaneously treated
Informed consent to trial participation and personal data treatment