NL-OMON54820招募中不适用
Immunological effects of stereotactic radiotherapy - An exploratory trial (iDOSE) - iDOSE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Have a diagnosis of cytologically proven or suspicion on early stage
- •(T1N0-T3N0/Nx) NSCLC, for which SABR has been recommended following discussions
- •within a multi-disciplinary tumor board.
- •2. Be willing and able to provide written informed consent for the trial.
- •3. Be 18 years of age on day of signing informed consent.
排除标准
- •1. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy
- •or any other form of immunosuppressive therapy within 30 days prior to the
- •planned SABR.
- •2. Has had prior chemotherapy, targeted small molecule therapy, or radiation
- •therapy within 30 days prior to SABR.
- •3. Has a known additional malignancy that is progressing or requires active
- •treatment. Exceptions include basal cell carcinoma of the skin, squamous cell
- •carcinoma of the skin, or in situ cervical cancer that has undergone
- •potentially curative therapy.
- •4. Has an active autoimmune disease requiring systemic treatment within the
- •past 3 months or a documented history of clinically severe autoimmune disease,
- •or a syndrome that requires systemic steroids or immunosuppressive agents.
- •Subjects with vitiligo or resolved childhood asthma/atopy would be an exception
- •to this rule. Subjects that require intermittent use of bronchodilators or
- •local steroid injections would not be excluded from the study. Subjects with
- •hypothyroidism stable on hormone replacement or Sjorgen*s syndrome will not be
- •excluded from the study.
- •5. Has a history of (non-infectious) pneumonitis that required steroids,
- •evidence of interstitial lung disease or active, non-infectious pneumonitis.
- •6. Has an active infection requiring systemic therapy.
- •7. Has a history or current evidence of any condition, therapy, or laboratory
- •abnormality that might confound the results of the trial, interfere with the
- •subject*s participation for the full duration of the trial, or is not in the
- •best interest of the subject to participate, in the opinion of the treating
- •investigator.
- •8. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2
- •antibodies) or a known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C
- •(e.g., HCV RNA [qualitative] is detected).
研究者
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