Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease (PROMISSeD Trial)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Number of patients who have skeletal-related events (SREs)
研究概览
简要总结
Early palliative care has been shown to improve the quality of life and even survival for patients with metastatic cancer. More and more supportive oncology teams in cancer centers now advocate for early integration of radiation therapy (RT) in a patient's palliative management course. While multiple randomized studies have evaluated the efficacy of different RT regimens in the treatment of symptomatic bone lesions, few studies have examined the impact of early, upfront RT for asymptomatic or minimally symptomatic (non- opioid dependent) spine metastases and its efficacy in preventing skeletal-related events (SREs). Since the pathophysiology of spinal metastatic disease is distinct from other bony metastatic disease, the proposed trial seeks to understand whether it is beneficial to patients with minimally symptomatic disease to undergo upfront RT to reduce the risks of SREs and their sequelae, including hospitalizations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging.
- •Has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risk metastases are defined as:
- •Bulkiest sites of spinal osseous disease ≥ 2cm,
- •Disease at junctional levels, including the thoracic apex (Occiput to C2, C7-T1, T12-L2, and L5- S1)
- •Disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints.
- •Vertebral body compression deformity > 50%.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 -
- •Age ≥ 18 years.
- •Able to provide informed consent.
- •Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating.
排除标准
- •Previous RT to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
- •Serious medical co-morbidities precluding RT.
- •Pregnant or lactating women.
- •Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture.
- •Leptomeningeal disease.
- •Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.
研究组 & 干预措施
Standard of Care Systemic Therapy or Surveillance
Patients randomized to arm 1 will undergo appropriate systemic therapy as determined by their oncology team. These patients will either continue the current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to arm 1, these patients may also undergo palliative radiation therapy for progressive or painful lesions (a skeletal related event as defined in the study) at the time of symptom development*(not upfront palliative radiation therapy)
干预措施: Standard of care systemic therapy (Drug)
Prophylactic Radiation Therapy
Patients randomized to Arm 2 of the study will undergo upfront prophylactic radiotherapy to ≤ 5 highest risk bone metastases followed by standard of care, as defined by:
- Bulkiest sites of disease ≥ 2cm (can include paraspinal disease extension)
- Disease in junctional spine (Occ-C2, C7-T1, T12-L1, L5-S1)
- Disease with posterior element involvement (facet(s), interspinous)
- Compression Deformity > 50%
干预措施: Prophylactic Radiotherapy (Radiation)
结局指标
主要结局
Number of patients who have skeletal-related events (SREs)
时间窗: 1 year
Number of skeletal related events (SREs), which will be defined as pathological fractures, spinal cord compression, or interventions (palliative RT, interventional procedures, or spine surgery)
次要结局
- Pain-free survival (PFS)(Until 1 year)
- Pain-related quality of life(3 months, 6 months, and 12 months, optionally within 1 week of a skeletal-related event (SRE))
- Overall survival (OS)(Until 1 year)
- Number of skeletal-related event (SRE) hospitalizations(1 year)
- Adverse event frequency and severity(3 months, 6 months, and 12 months)
- Health care utilities and quality of life(3 months, 6 months, and 12 months, optionally within 1 week of a skeletal-related event (SRE))