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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 16
- 主要终点
- Complete pain response utilizing the Cochran-Mantel-Hanzeal test
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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
排除标准
- •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.
研究组 & 干预措施
Standard Conventional Radiotherapy
干预措施: Standard Conventional Radiotherapy (Radiation)
Stereotactic Body Radiotherapy
干预措施: Stereotactic Body Radiotherapy (Radiation)
结局指标
主要结局
Complete pain response utilizing the Cochran-Mantel-Hanzeal test
时间窗: 27 months
次要结局
- Incidence of treatment-related AE rates >/- grade 2 utilizing CTCAE v5(27 months)
- Imaging-based local control rates at 3 and 6 months post-treatment(27 months)
- Patient reported outcomes utilizing EORTC QLQ-C30(27 months)
- Patient reported outcomes utilizing EORTC QLQ-BM22(27 months)
- Pain response pattern at 3 months: partial, stable or progressive pain(27 months)
- Early (1 month post RT) and late (6 months post RT) CPR and response patterns (partial, stable, and progressive pain);(27 months)
- Re-irradiation rate within the 6-month follow-up period(27 months)
- Incidence of fracture at the radiation target site(27 months)