Ignite Creation Date:
2024-05-06 @ 12:18 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03727867
Status:
UNKNOWN
Last Update Posted:
2019-01-30
First Post:
2018-10-27
Brief Title:
Efficacy of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Combined With Early Stereotactic Body Radiation Therapy to the Primary Tumor in Advanced Non-small Cell Lung Cancer
Sponsor:
Haihua Yang
Organization:
Taizhou Hospital
Study Overview
Official Title:
A Randomized Ⅲ Phase Trial of Efficacy of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Combined With Early Stereotactic Body Radiation Therapy to the Primary Tumor in Advanced Non-small Cell Lung Cancer Patients Harboring Epidermal Growth Factor Receptor Mutation
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Non-small cell lung cancer NSCLC is a prevalent disease with high mortality and morbidity particularly of adenocarcinoma in Asians Fortunately with the development of epidermal growth factor receptor EGFR tyrosine kinase inhibitor TKI treatment of lung cancer usher in a new era resulting in a hit of precise therapy and molecule sequencing However it is inevitable for patients to gain acquired resistance of EGFR TKI Several studies have been demonstrated that there were approximately 30 heterogeneous cells in primary tumors And emerging studies illuminated that main pattern of treatment failure was the recurrence of primary site Moreover it was proved that despite of the drug-resistance cells in progressive site continual prescription of EGFR TKI in oligometastasis lung cancer could make a difference for patients in progression free survival PFS and overall survival OS owing to the residual responsive cells in another sites Therefore to explore an unique method to control heterogeneous cells in primary site so as to delay or prevent acquired resistance when taking EGFR TKI orally may be of great benefit and therapy
It is known to all that stereotactic body radiation therapy SBRT with the advantage of hypofractionation and rapid release succeed in several cancers such as early lung cancer prostatic liver cancer and so on for local control Numerous reports explained SBRT played an irreplaceable role in progressive NSCLC patients after oral targeted medicine regardless of EGFR or anaplastic lymphoma kinase ALK mutation And the radiosensitivity of EGFR TKI in vitro and vivo may account for these inspiring results Whats more it has reported that SBRT could induce inflammatory cell death activate dendritic cell as well as accelerate antigen presentation in the draining lymph node leading to antigen-specific adaptive immune response Nevertheless although the potential effects of SBRT on advanced NSCLC are obviously few studies explore the preventive benefits of early SBRT combined with oral EGFR TKI on advanced lung cancer by eliminating the heterogeneous cells in primary site In addition the investigators previous phase II study of SBRT combined with oral EGFR TKI had revealed its safety and potentially improvement of PFS for 6 months
In this trial the investigators put sight into assessing the efficacy of early application of SBRT to primary site in the advanced NSCLC patients and provide a hypothesis that early SBRT could strengthen the anti-tumor effect of EGFR TKI through eradicating the heterogenity of initial tumor cells
It is known to all that stereotactic body radiation therapy SBRT with the advantage of hypofractionation and rapid release succeed in several cancers such as early lung cancer prostatic liver cancer and so on for local control Numerous reports explained SBRT played an irreplaceable role in progressive NSCLC patients after oral targeted medicine regardless of EGFR or anaplastic lymphoma kinase ALK mutation And the radiosensitivity of EGFR TKI in vitro and vivo may account for these inspiring results Whats more it has reported that SBRT could induce inflammatory cell death activate dendritic cell as well as accelerate antigen presentation in the draining lymph node leading to antigen-specific adaptive immune response Nevertheless although the potential effects of SBRT on advanced NSCLC are obviously few studies explore the preventive benefits of early SBRT combined with oral EGFR TKI on advanced lung cancer by eliminating the heterogeneous cells in primary site In addition the investigators previous phase II study of SBRT combined with oral EGFR TKI had revealed its safety and potentially improvement of PFS for 6 months
In this trial the investigators put sight into assessing the efficacy of early application of SBRT to primary site in the advanced NSCLC patients and provide a hypothesis that early SBRT could strengthen the anti-tumor effect of EGFR TKI through eradicating the heterogenity of initial tumor cells
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None