A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 5
- 主要终点
- Overall Survival
研究概览
简要总结
This study is a phase III multi-institutional randomized trial. Patients will be randomized in a 1:2 ratio between current standard of care treatment (Arm 1) vs. standard of care treatment + SABR (Arm 2) to sites of known disease.
Patients will be stratified by two of the strongest prognostic factors, based on a large multi-institutional analysis3: histology (Group 1: hormone-sensitive prostate cancer, breast, or renal; Group 2: all others), and number of metastases (Group 1: 1-3; Group 2: 4-10).
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 years or older
- •Willing to provide informed consent
- •Karnofsky performance status > 60
- •Life expectancy > 6 months
- •Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
- •Total number of metastases 1-10 at the time of enrollment, with a primary tumor also present
- •Restaging completed within 12 weeks prior to randomization (see section 5.1)
- •For patients receiving thoracic radiotherapy, the enrolling physician must confirm there are no computed tomography (CT) changes suggestive of fibrotic interstitial lung disease (ILD) (i.e. reticular changes, traction bronchiectasis, or honeycombing) reported on any prior CT scans. If any are present, the patient must be assessed by a respirologist to rule out ILD prior to enrollment.
- •10 or fewer lifetime metastases from the cancer for which participants are being enrolled
排除标准
- •Serious medical comorbidities precluding radiotherapy. These include ILD in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI) tract will receive radiotherapy, or ulcerative colitis where the bowel 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); please see the Child-Pugh score calculator.
- •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 in Appendix
- •All such cases must be discussed with a member of the study steering committee.
- •Malignant pleural effusion
- •Inability to treat all sites of disease
- •Brain metastasis > 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
- •Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), or skin
- •Pregnant or lactating women
研究组 & 干预措施
Standard Arm (Arm 1)
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.
干预措施: Palliative Radiotherapy (Radiation)
Standard Arm (Arm 1)
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.
干预措施: Chemotherapy (Drug)
Standard Arm (Arm 1)
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.
干预措施: Hormone therapy (Drug)
Standard Arm (Arm 1)
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.
干预措施: Immunotherapy (Drug)
Standard Arm (Arm 1)
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.
干预措施: Targeted Systemic Therapy (Drug)
Standard Arm (Arm 1)
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.
干预措施: Observation (Other)
Experimental Arm (Arm 2)
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
干预措施: Palliative Radiotherapy (Radiation)
Experimental Arm (Arm 2)
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
干预措施: Chemotherapy (Drug)
Experimental Arm (Arm 2)
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
干预措施: Hormone therapy (Drug)
Experimental Arm (Arm 2)
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
干预措施: Immunotherapy (Drug)
Experimental Arm (Arm 2)
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
干预措施: Targeted Systemic Therapy (Drug)
Experimental Arm (Arm 2)
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
干预措施: Observation (Other)
Experimental Arm (Arm 2)
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
干预措施: Stereotactic Ablative Radiotherapy (Radiation)
Experimental Arm (Arm 2)
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
干预措施: Surgery (Procedure)
Experimental Arm (Arm 2)
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
干预措施: Radiofrequency Therapy (RFA) (Other)
Experimental Arm (Arm 2)
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
干预措施: Fractionated Radiation (Radiation)
结局指标
主要结局
Overall Survival
时间窗: Approximately end of year 6 (Study Completion)
Time from randomization to death from any cause, or date of last follow-up, whichever occurs first.
次要结局
- Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: General (FACT-G).(Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months))
- Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: The EuroQol 5-Dimension 5-Level (EQ-5D-5L).(Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months))
- Toxicity assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5 for each organ treated (e.g. liver, lung, bone).(Toxicity outcomes to be collected for the first 2 years (Last week of treatment, in 6 weeks, in 3, 6, 12, 18, 24 months))
- Time to next systemic therapy(From randomization to year 6 (study completion).)
- Receipt of additional radiation during follow-up(During year 6 (follow-up year).)
研究者
David Palma
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's