NCT06150222尚未招募不适用
Retrospective Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study (Retro-COSMOS). An EMBRACE Collaborative Initiative in Recurrent and Metastatic Cervix Cancer.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 主要终点
- 3-year overall survival
研究概览
简要总结
This multi centric international retrospective study aims to register patients with oligo metastatic and oligo recurrent cervical cancer. The study will register patients in planned period with an aim to analyse clinical outcomes with or without use of radiation in this setting.
详细描述
Detailed clinical protocol can be obtained by contacting the principal investigator.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cervical cancer with (induced) oligo-metastatic and/or oligo-recurrent cervix cancer whether treated or not treated with radiation. These patients may have received previous treatment within or outside approved clinical trials/studies.
- •Patients with poly-metastatic disease with good response to systemic chemotherapy and treated with radiation to recurrence or metastatic site.
- •Patients treated with radical doses at the time of first diagnosis of oligo-metastasis/oligo-recurrence and present with further oligo-progression.
- •Patients with oligo-metastasis or oligo-recurrence treated with other locally directed therapies (like surgery, ablation, etc.) are also permitted.
排除标准
- •Gynecological cancer other than cervical cancer
- •Persistent Poly-metastatic disease post systemic treatment
- •Receiving investigational new drugs at the time of relapse as part of other ongoing trials
- •No clinical follow up after treatment
结局指标
主要结局
3-year overall survival
时间窗: From date of diagnosis of recurrence untill the date of death due to any cause or date of censoring at the last time the subject was known to be alive, whichever came first, assessed upto 3 years after initiation of the study
To estimate overall survival of patients diagnosed with oligo-recurrent and (induced) oligo-metastatic cervix cancer.
次要结局
- Moderate to severe adverse events within the (induced) oligo-metastatic and oligo-recurrent setting ( including toxicity with targeted agents like bevacuzimab and pembrolizumab)(From date of start of treatment of recurrence to end of study, assessed upto 3 years after initiation of the study)
- Report on various risk groups within oligo-metastatic and oligo-recurrent setting(From date of recurrence to end of study, assessed upto 3 years after initiation of the study)
- 3- year Progression free survival(From date of first disease progression to subsequent disease progression or death from any cause, whichever came first, assessed upto 3 years after initiation of the study)
- Dose response relationship of nodal and visceral progressions(From date of start of treatment of disease progression, assessed upto 3 years)
- Nomogram which correlates risk groups with expected outcomes within the (induced) oligo-metastatic and oligo-recurrent setting(From date of recurrence to end of study, assessed upto 3 years after initiation of the study)
- 3-year Infield progression free survival(From date of first disease progression to date of subsequent progression or death from any cause, whichever came first, assessed upto 3 years after initiation of the study)
- Dose response relationship within setting of re-irradiation (infield progressions)(From date of start of treatment of disease progression, assessed upto 3 years)
- Tissue based biomarkers(From date of start of recurrence to end of study, assessed upto 3 years after initiation of the study)
研究者
Prof. Dr. Remi A. Nout
Head of Department of Radiation Oncology
Erasmus Medical Center
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