跳至主要内容
临床试验/CTRI/2022/05/042654
CTRI/2022/05/042654招募中未知

ocally Ablative Therapy for Oligo-Progressive, Oligo-Recurrent and Oligo-Persistent Non-Small Cell Lung Cancer â?? An Ambispective Observational Cohort study (OLIGO-CHROME)

Anil Tibdewal0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
招募中
发起方

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

入选标准

  • 1)Patients with histopathological diagnosis of non-small cell lung cancer
  • 2)Patients with age > 18 years
  • 3)Patients with confirmed oligoprogression in <=3 intracranial and extracranial sites of disease (excluding primary and regional nodal sites) - All sites must be visible, imaging defined targets, not previously treated with radical radiation or radiofrequency and suitable for treatment with LAT as determined by the radiation oncologist).
  • 4)Patients with oligoprogression in <=5 intracranial disease sites with no extracranial sites of progression. All sites must be visible, imaging defined targets, previous treatment of current sites with WBRT/SRS is acceptable with duration between treatment and OP is at-least 6 months.
  • 5)Patients with oligorecurrent disease at primary and/or regional nodal sites (previously covered in RT portal is allowed if can be treated radically again) with or without distant metastases in previously treated non-metastatic NSCLC.
  • 6)Patients with metastatic NSCLC with all sites responding to systemic therapy (TKI/Chemotherapy/ICI) except few (1-3) â?? Oligopersistent diseases
  • 7)Patient with completely resolved or stable pleural effusion is allowed but with no new onset malignant pleural or pericardial effusion
  • 8)All sites must be amenable either by local ablative radiation therapy (with SBRT/ Radical RT - conventional or hypofractionated RT) or RFA or Surgery
  • 9)At least one site should be treated with radiation therapy. Only RFA or Only Surgically treated patients will be excluded except patients with post-operative whole brain radiation therapy with or without boost or post-operative cavity stereotactic radiosurgery.
  • 10)Adequate baseline organ function to allow LAT to all the OP, OR or Oligopersistent targets.
  • 11)Karnofsky Performance status >= 60 and ECOG 0-2 (except patients with brain metastases where PS is declined solely due to brain s)
  • 12)Provision of written informed consent

排除标准

  • 1)Age < 18 years
  • 2) > 3 sites of oligoprogressive disease (except mentioned for intracranial sites only)
  • 3)OP, OR and oligopersistence disease not amenable to LAT
  • 4)Co-morbidities considered clinically precluding the safe use of LAT
  • 5)Any psychological, sociological or geographical issue potentially hampering compliance with the study
  • 6)Pregnancy

研究者

发起方
Anil Tibdewal

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