NL-OMON37922已完成2 期
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET): A Randomized Phase II Trial - SABR-COMET
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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 99（—）
入选标准
- •Age 18 or older.
- •Willing to provide informed consent.
- •Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
- •ECOG performance status 0-1.
- •Controlled primary tumor, defined as: at least 3 months since original tumor treated definitively, with no progression at primary site.
- •All sites of disease can be safely treated based on criteria below
- •Maximum 3 metastases in any single organ system (i.e. lung, liver, brain, bone)
- •Life expectancy >6 months
- •Not a candidate for surgical resection at all sites: surgery to all sites not recommended by multidisciplinary team, or unfit or declining surgery
- •Prior chemotherapy allowed but no chemotherapy (cytotoxic or molecularly targeted agents) therapy 4 weeks prior to first fraction of radiotherapy, during radiotherapy, or for two weeks after last fraction. Hormonal therapy is allowed.
- •Patients with metastases that have been previously treated (e.g. prior resection, RFA or radiotherapy):
- •*If that previously treated metastasis is controlled on imaging, the patient is eligible for this study and that site does not need treatment
- •*If that previously treated metastasis is NOT controlled on imaging:
- •* If the previous treatment was surgery, the patient is eligible if
- •that site can be treated by SABR
- •* If the previous treatment was radiotherapy or RFA, the patient is ineligable;Patient presented at multidisciplinary tumor board or quality-assurance rounds.
排除标准
- •Serious medical comorbidities precluding radiotherapy
- •Bone metastasis in a femoral bone
- •Patients with 1-3 brain metastasis and no disease elsewhere (these patients should not be randomized but treated with stereotactic radiotherapy as per results of randomized trials)
- •Prior radiotherapy to a site requiring treatment
- •Complete response to first-line chemotherapy (i.e. no measurable target for SABR)
- •Malignant pleural effusion
- •Inability to treat all sites of active disease
- •Clinical or radiologic evidence of spinal cord compression OR tumor within 3 mm of spinal cord on MRI.
- •Dominant brain metastasis requiring surgical decompression
- •Pregnant or lactating women
研究者
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