Resectable early-stage non-small cell lung cancer
Conditions
Interventions
Preoperative tumour treating fields therapy (3 weeks) and lung resection
Sponsors
Aokage Keiju
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Non-small cell lung cancer diagnosed by histology, biopsy, or cytology from the primary tumor site. 2) Meet given criteria of early resectable disease on chest contrast-enhanced CT and thin-slice chest CT, FDG-PET/CT, and brain contrast-enhanced CT or MRI. 3) Performance status is ECOG 0 or 1. 4) No history of radiation therapy to the chest (lung, hilum, mediastinum). 5) Meet given criteria for the resting 12-lead electrocardiogram. 6) Anatomically eligible for radical resection via lung resection. 7) Forced expiratory volume in 1 second (FEV1.0) equal to 800 mL or more within 56 days prior to enrollment, and SpO2 (room air) equal to 93% or more within 14 days prior to enrollment. 8) Meets given criteria of labs within 28 days prior to enrollment. 9) Age is 18 years or older on the date of enrollment. 10) Comply to the protocol of this study 11) Written informed consent for this clinical trial.
Exclusion criteria
Exclusion criteria: 1) Active multiple primary cancers. 2) History of pacemaker use or having schedule to undergo a new terapeutic intervention for ischemic heart disease or to implant pacemaker for arrhythmia at the time of enrollment. 3) Psychiatric disorders, substance dependence, etc. which impaire consent to this study. 4) Women who are pregnant, may be pregnant, are attempting to become pregnant, or are breastfeeding 5) Any other unsuitable reason deemed by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Protocol treatment completion rate | — |
Secondary
| Measure | Time frame |
|---|---|
| - Surgery implementation rate - Pathological complete resection rate - Pathological complete response rate - Major pathological response rate - Overall survival - Progression-free survival - Pattern of recurrence - Local recurrence rate - Postoperative respiratory function - Quality of life - Device wear time - Device wear rate - Adverse event rate - Device malfunction rate - Surgery duration - Blood loss | — |
Contacts
Public ContactHiroshi Miyamoto
FIVERINGS CO.,LTD.
Outcome results
None listed