Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases

Официальное название

A Randomized Phase III Trial Comparing Stereotactic Body Radiotherapy to Conventional Palliative Radiotherapy (SBRT) Versus Conventional Palliative Radiotherapy (CRT) for Participants With Painful Non-Spine Bone Metastases

Обзор

This study is being done to answer the following question: Is Stereotactic Body Radiation Therapy or SBRT (a form of radiation therapy which can deliver high doses of radiation to the specific painful area of the body most affected by cancer, while keeping the radiation beams away from the healthy parts of the body that surround the cancer) better for pain relief than the standard treatment of conventional radiation therapy or CRT (a form of radiation therapy which delivers radiation to the painful area but can also negatively affect other parts of the body in the same area)

Подробное описание

This is a multi-centre, phase III randomized controlled trial comparing SBRT to conventional palliative EBRT in patients with solid tumours and a dominant painful non-spine bone metastasis as defined by a worst pain score of 2 or greater. 230 participants will be enrolled to the study. Participants will have radiation for 5 treatments (conventional palliative EBRT 20Gy/5; SBRT 30Gy/5 or 35Gy/5) and then will be followed for pain response and radiological progression at 3 and 6 months post treatment.

Вмешательства

• Лучевая терапия Standard Conventional Radiotherapy
  20Gy in 5 fractions
• Лучевая терапия Stereotactic Body Radiotherapy
  30 or 35Gy in 5 fractions

Первичные конечные точки

• Complete pain response utilizing the Cochran-Mantel-Hanzeal test [Срок оценки: 27 months]

Вторичные конечные точки (8)

• Pain response pattern at 3 months: partial, stable or progressive pain [Срок оценки: 27 months]
• Early (1 month post RT) and late (6 months post RT) CPR and response patterns (partial, stable, and progressive pain); [Срок оценки: 27 months]
• Re-irradiation rate within the 6-month follow-up period [Срок оценки: 27 months]
• Incidence of fracture at the radiation target site [Срок оценки: 27 months]
• Incidence of treatment-related AE rates >/- grade 2 utilizing CTCAE v5 [Срок оценки: 27 months]
• Imaging-based local control rates at 3 and 6 months post-treatment [Срок оценки: 27 months]
• Patient reported outcomes utilizing EORTC QLQ-C30 [Срок оценки: 27 months]
• Patient reported outcomes utilizing EORTC QLQ-BM22 [Срок оценки: 27 months]

Критерии участия

Критерии включения

• Histologic confirmation of solid tumour.
• Patient with a dominant painful non-spine bone metastasis and a worst minimum pain score of 2 using the BPI attributed to that dominant site
• Expected overall survival of greater than 6 months as determined by the treating physician
• Suitable for protocol defined SBRT and CRT.
• Stable pain with no immediate plan to alter analgesic regimen.
• ECOG performance status of 0-2.
• Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate

Критерии исключения

• Metastases of the hands, feet, cranium or spine (including sacrum) as the dominant/index pain site.
• Bone metastasis arising from a small cell or germ cell.
• Radionuclide therapy within 30 days of randomization.
• Patient treated with prior palliative RT to the dominant painful bone metastasis site (prior radiation exposure is permitted if prior to development of the dominant metastasis and would not influence the applicability of either treatment arm of the current study).
• Received systemic chemotherapy within 1 week of the protocol RT, or who are expected/planned to receive chemotherapy within one week of completing protocol RT.
• Participants with an unstable pathologic fracture at the dominant painful bone metastasis, or for whom surgical fixation would be the preferred intervention if possible.
• Pregnant or lactating individuals.

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

Канада · 9 центров

• BCCA - Vancouver — Vancouver
• Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton
• Kingston Health Sciences Centre — Kingston
• London Health Sciences Centre Research Inc. — London
• Stronach Regional Health Centre at Southlake — Newmarket
• Odette Cancer Centre — Toronto
• University Health Network — Toronto
• CHUM-Centre Hospitalier de l'Universite de Montreal — Montreal
• … и ещё 1 центр

Идентификаторы

NCT: NCT06391242 · SC29

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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