Ignite Creation Date:
2024-05-06 @ 3:22 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02277457
Status:
WITHDRAWN
Last Update Posted:
2016-06-24
First Post:
2014-10-24
Brief Title:
Personalized Adaptive Radiation Therapy With Individualized Systemic Targeted Therapy PARTIST for Locally Advanced Non-small Cell Lung Cancer With Genomic Driver Mutations
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Personalized Adaptive Radiation Therapy With Individualized Systemic Targeted Therapy PARTIST for Locally Advanced Non-small Cell Lung Cancer With Genomic Driver Mutations
Status:
WITHDRAWN
Status Verified Date:
2016-06
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:
None
Brief Summary:
Hypotheses
Short-term - Targeted therapy with erlotinib or crizotinib plus PART Personalized Adaptive Radiation Therapy will be safe and will yield favorable outcomes in patients with stage III EGFR Epidermal Growth Factor Receptor or ALK Anaplastic Lymphoma Kinase NSCLC Non-Small Cell Lung Cancer
Long-term - In patients with stage III NSCLC harboring driver mutations treatment with relevant targeted agents plus PART will improve both local-regional and systemic tumor control resulting in improved survival relative to standard chemoradiotherapy
Short-term - Targeted therapy with erlotinib or crizotinib plus PART Personalized Adaptive Radiation Therapy will be safe and will yield favorable outcomes in patients with stage III EGFR Epidermal Growth Factor Receptor or ALK Anaplastic Lymphoma Kinase NSCLC Non-Small Cell Lung Cancer
Long-term - In patients with stage III NSCLC harboring driver mutations treatment with relevant targeted agents plus PART will improve both local-regional and systemic tumor control resulting in improved survival relative to standard chemoradiotherapy
Detailed Description:
The proposed trial is a pilot study that will accrue 30 patients with inoperable stage IIIAB NSCLC harboring either an EGFR mutation n20 or an ALK rearrangement n10 Patients with EGFR tumors will be treated with erlotinib 150 mg orally QD patients with ALK tumors will be treated with crizotinib 250 mg orally BID Treatment consists of six weeks of concurrent PART plus erlotinib or crizotinib followed by erlotinib or crizotinib for a total of 1 year All patients will be treated with response-driven PART with dose intensified to the active FDG-avid region based on a mid-treatment FDG-PETCT scan while maintaining dose limits for organs-at-risk The primary endpoints will be PFS and OS Primary analyses will be performed separately for ALK and EGFR patients The secondary endpoint of treatment-related toxicity will focus on pneumonitis and esophagitis with a strict stopping rule in place
Current standard therapy affords suboptimal outcomes for patients with locally advanced NSCLC due to both locoregional and distant recurrences Since targeted therapy is more effective than chemotherapy in patients with relevant driver mutations the best way to significantly improve outcomes in this subgroup of patients is to optimize systemic therapy with targeted agents while improving local control with PET-adapted high-dose RT
Current standard therapy affords suboptimal outcomes for patients with locally advanced NSCLC due to both locoregional and distant recurrences Since targeted therapy is more effective than chemotherapy in patients with relevant driver mutations the best way to significantly improve outcomes in this subgroup of patients is to optimize systemic therapy with targeted agents while improving local control with PET-adapted high-dose RT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HUM00094166 | OTHER | University of Michigan | None |