A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 204
- 试验地点
- 14
- 主要终点
- Overall Survival at Study Completion
研究概览
简要总结
In patients with a limited oligometastatic burden (cancer has spread but is not yet considered metastatic), emerging evidence suggests that treatment of all sites of disease with ablative therapies can improve patient outcomes, including overall- and progression-free survival. The application of Stereotactic Ablative Radiotherapy (SABR) for patients with 4-10 metastatic deposits appears promising, yet it is unclear if all patients with greater than 3 oligometastatic lesions benefit from ablative therapies in terms of improved Overall Survival (OS), Progression Free Survival (PFS), or quality of life. The purpose of this study is to assess the impact of SABR, compared to standard of care treatment, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumor and 4-10 metastatic lesions.
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
- •Age 18 or older
- •Willing to provide informed consent
- •Karnofsky performance score greater than 60
- •Life expectancy greater than 6 months
- •Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
- •Controlled primary tumor defined as: at least 3 months since original tumor treated definitively, with no progression at primary site
- •Total number of metastases 4-10
- •All sites of disease can be safely treated based on a pre-plan
排除标准
- •Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract will receive radiotherapy, and connective tissue disorders such as lupus or scleroderma.
- •For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C)
- •Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases must be discussed with one of the study PIs.
- •Malignant pleural effusion
- •Inability to treat all sites of disease
- •Any single metastasis greater than 5 cm in size.
- •Any brain metastasis greater than 3 cm in size or a total volume of brain metastases greater than 30 cc.
- •Metastasis in the brainstem
- •Clinical or radiologic evidence of spinal cord compression
- •Dominant brain metastasis requiring surgical decompression
- •Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), mesenteric lymph nodes, or skin
- •Pregnant or lactating women
研究组 & 干预措施
Standard arm
Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
干预措施: Immunotherapy (Drug)
Standard arm
Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
干预措施: Hormones (Drug)
Standard arm
Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
干预措施: Palliative Radiation (Radiation)
Standard arm
Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
干预措施: Chemotherapy (Drug)
Standard arm
Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
干预措施: Observation (Other)
Stereotactic Arm
Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
干预措施: Chemotherapy (Drug)
Stereotactic Arm
Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
干预措施: Immunotherapy (Drug)
Stereotactic Arm
Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
干预措施: Hormones (Drug)
Stereotactic Arm
Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
干预措施: Observation (Other)
Stereotactic Arm
Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
干预措施: Stereotactic Ablative Radiotherapy (Radiation)
结局指标
主要结局
Overall Survival at Study Completion
时间窗: At approximately end of year 6 (study completion)
Time from randomization to death from any cause.
次要结局
- Quality of Life as measured by the Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire(At approximately end of year 6 (study completion))
- Overall Survival at midpoint of Study(At approximately year 3 (midpoint))
- Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire(At approximately end of year 6 (study completion))
- Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0(End of years 1, 2, 3, 4, 5, and 6 (study completion))
- Progression-free Survival(At approximately year 3, and end of year 6 (study completion))
- Time from randomization to development of new metastatic lesions(At approximately end of year 6 (study completion))
研究者
David Palma
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's