Ignite Creation Date:
2024-05-06 @ 1:37 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04072107
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-18
First Post:
2019-08-24
Brief Title:
EPstein-barr Virus DNA Response to Systemic Therapy for Treatment Adaptation in High Risk NPC EP-STAR
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Epstein-Barr Virus DNA to Systemic Therapy for Treatment Adaptation in High Risk Nasopharyngeal Carcinoma EP-STAR Trial A Phase II Multi-center Biomarker-guided Umbrella Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
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:
EP-STAR
Brief Summary:
The investigators aim to investigate whether incorporating on-treatment EBV DNA surveillance for monitoring tumor responses to treatment and for guiding individuliased treatment adaptation can improve prognosis in nasopharyngeal carcinoma patient For patients with detectable EBV DNA after one cycle of IC which then drops to undetectable levels during the following IC cycles intermediate respondersintermediate relapse risk the investigators aim to investigate whether additional adjuvant metronomic capecitabine would benefit this subgroup For patients with detectable EBV DNA after three cycles of IC or with EBV DNA bounce during the induction phase insensitive to IChigh relapse risk the investigators aim to investigate whether concurrent administration of anti-PD-1 therapy during the following treatment phases including concurrent phase and adjuvant phase can benefit this subgroup
Detailed Description:
Nasopharyngeal carcinoma NPC is a unique head and neck cancer characterized by an extremely unbalanced global distribution The highest incidence is observed in endemic regions such as southern China and Southeast Asia with an age-standardized rate of 30 per 100000 in China to 04 per 100000 in Caucasian populations The fast progress of modern imaging and the application of intensity-modulated radiotherapy IMRT has improved the local control rate significantly Distant metastasis has become the major cause of treatment failure
The 2018 National Comprehensive Cancer Network NCCN guideline recommends concurrent chemoradiotherapy CCRT induction chemotherapy ICadjuvant chemotherapy AC as the standard treatment for stage II-IVa disease category 2A While it is worth noting that there is extensive heterogeneity among patients with NPC and even among patients with the same disease stage the risk of relapse varies More importantly patients can have differing sensitivity to RT and chemotherapy The abovementioned reasons result in over-treatment in some patients with relatively low relapse risk intensive treatments lead to unnecessary toxicities and greatly affect quality of life QoL On the other hand the current treatment strategy may be not optimal for patients with high relapse risk or who are not sensitive to traditional chemoradiotherapy Therefore there is an urgent need for identifying and applying promising biomarkers real-time monitoring of patient responses to treatment predicting relapse risk and guiding real-time treatment adaptation for individualized therapy
The investigators aim to investigate whether incorporating on-treatment EBV DNA surveillance for monitoring tumor responses to treatment and for guiding individuliased treatment adaptation can improve prognosis in nasopharyngeal carcinoma patient For patients with detectable EBV DNA after one cycle of IC which then drops to undetectable levels during the following IC cycles intermediate respondersintermediate relapse risk the investigators aim to investigate whether additional adjuvant metronomic capecitabine would benefit this subgroup For patients with detectable EBV DNA after three cycles of IC or with EBV DNA bounce during the induction phase insensitive to IChigh relapse risk the investigators aim to investigate whether concurrent administration of anti-PD-1 therapy during the following treatment phases including concurrent phase and adjuvant phase can benefit this subgroup
The 2018 National Comprehensive Cancer Network NCCN guideline recommends concurrent chemoradiotherapy CCRT induction chemotherapy ICadjuvant chemotherapy AC as the standard treatment for stage II-IVa disease category 2A While it is worth noting that there is extensive heterogeneity among patients with NPC and even among patients with the same disease stage the risk of relapse varies More importantly patients can have differing sensitivity to RT and chemotherapy The abovementioned reasons result in over-treatment in some patients with relatively low relapse risk intensive treatments lead to unnecessary toxicities and greatly affect quality of life QoL On the other hand the current treatment strategy may be not optimal for patients with high relapse risk or who are not sensitive to traditional chemoradiotherapy Therefore there is an urgent need for identifying and applying promising biomarkers real-time monitoring of patient responses to treatment predicting relapse risk and guiding real-time treatment adaptation for individualized therapy
The investigators aim to investigate whether incorporating on-treatment EBV DNA surveillance for monitoring tumor responses to treatment and for guiding individuliased treatment adaptation can improve prognosis in nasopharyngeal carcinoma patient For patients with detectable EBV DNA after one cycle of IC which then drops to undetectable levels during the following IC cycles intermediate respondersintermediate relapse risk the investigators aim to investigate whether additional adjuvant metronomic capecitabine would benefit this subgroup For patients with detectable EBV DNA after three cycles of IC or with EBV DNA bounce during the induction phase insensitive to IChigh relapse risk the investigators aim to investigate whether concurrent administration of anti-PD-1 therapy during the following treatment phases including concurrent phase and adjuvant phase can benefit this subgroup
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