Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)
Phase II Study of Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib for Patients With Epidermal Growth Factor Receptor(EGFR) Mutation Who Have Previously Progressed on an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor (EGFR-TKI)
1 other identifier
interventional
32
1 country
8
Brief Summary
\- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2012
Longer than P75 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2012
CompletedFirst Posted
Study publicly available on registry
April 9, 2012
CompletedStudy Start
First participant enrolled
December 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2019
CompletedResults Posted
Study results publicly available
January 12, 2021
CompletedJanuary 12, 2021
December 1, 2020
6.3 years
April 5, 2012
September 16, 2020
December 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Progression Free Survival
Progression free survival (PFS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-tyrosine kinase inhibitor (TKI) therapy reported as percentage of participants who are alive and without progressive disease at 3 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.
3 months after Initiation of Stereostatic Radiotherapy
Secondary Outcomes (4)
Percentage of Participants With Local Control of Sites on Erlotinib Following Stereotactic Radiosurgery (SRS)
Initiation of Stereotactic Radiotherapy every 6 to 12 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Median Overall Survival
up to 5 years after end of treatment
Toxicity Rate From Stereotactic Radiosurgery (SRS)
From initiation to the end of SRS, up to 15 days
Toxicity Rate Attributed to Erlotinib
from end of SRS to end of erlotinib treatment (median duration of 5.7 months)
Study Arms (1)
Stereotactic Radiosurgery Followed by Erlotinib
OTHERStereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib
Interventions
21 Gy daily for 5 days
Eligibility Criteria
You may qualify if:
- Written informed consent
- years of age or older
- Histologically or cytologically confirmed stge IV EGFR-mutant NSCLC
- History of previous response to EGFR-TKI defined by a RECIST 1.1 criteria
- Progressive disease following EGFR-TKI therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ and marrow function
- Negative urine or serum pregnancy test for female patients
- Patients who can have children must agree to adequate contraception
You may not qualify if:
- Unresolved chronic toxicities greater than 2, measured by CTCAE v4
- Treatment with any FDA approved or experimental cancer treatment following progression on EGFR-TKI
- Any history of previous greater than grade 3 toxicity attributable to erlotinib
- Pregnant or lactating female
- Any previous radiation to sites of planned Stereostatic Radiosurgery
- History of another malignancy
- Concomitant anticancer therapy, immunotherapy, or radiation therapy (within 4 weeks)
- Evidence of severe or uncontrolled systemic diseases
- Known hypersensitivity reaction or idiosyncrasy to erlotinib
- Psychological, familial, sociological, or geographical conditions
- Any other condition in investigator's opinion jeopardize compliance with protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University of California at San Francisco
San Francisco, California, 94115, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
East Carolina University
Greenville, North Carolina, 27834, United States
STO Taussig Cancer Center; Cleveland Clinic
Cleveland, Ohio, 44195, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study closed early due to poor accrual (enrolling only 25 of 40 expected participants) and the development of second line therapy with osimertinib.
Results Point of Contact
- Title
- Robin V. Johnson
- Organization
- UNC Lineberger Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jared Weiss, MD
UNC at Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2012
First Posted
April 9, 2012
Study Start
December 11, 2012
Primary Completion
March 15, 2019
Study Completion
March 15, 2019
Last Updated
January 12, 2021
Results First Posted
January 12, 2021
Record last verified: 2020-12