NL-OMON52850招募中3 期
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10) - SABR-COMET 10
ondon Health Sciences Center- Lawson Health Research Institute0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Age 18 or older
- •Willing to provide informed consent
- •Karnofsky performance score >60
- •Life expectancy >6 months
- •Histologically confirmed malignancy with metastatic disease detected on
- •imaging. Biopsy of metastasis is preferred, but not required.
- •Restaging within 12 weeks prior to randomization:
- •o Brain: CT or MRI for tumor sites with propensity for brain metastasis. All
- •patients with brain metastases (at enrollment or previously treated) require an
- •o Body: 18-FDG PET/CT imaging is recommended, except for tumors where FDG
- •uptake is not expected (e.g. prostate, renal cell carcinoma). PSMA-PET or
- •choline-PET is recommended for prostate cancer. In situations where a PET scan
- •is unavailable, or for tumors that do not take up radiotracer, CT
- •neck/chest/abdomen/pelvis with bone scan required.
- •o Spine: MRI required for patients with vertebral or paraspinal metastases. The
- •MRI needs to image the area being treated and one vertebrae above and below as
- •a minimum, but does not need to be a whole spine MRI unless clinically
- •Controlled primary tumor
- •o 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, 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)
- •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 1. 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 >5 cm in size. Bone metastases larger than 5 cm may be
- •included if, in the opinion of one of the study PIs, it can be treated safely.
- •Any 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
- •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
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