Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)
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| ClinicalTrials.gov Identifier: NCT01573702 |
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Recruitment Status :
Completed
First Posted : April 9, 2012
Results First Posted : January 12, 2021
Last Update Posted : January 12, 2021
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Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborator:
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Non Small Cell Lung Cancer |
| Interventions |
Procedure: Stereotactic Radiosurgery Drug: Erlotinib |
| Enrollment | 32 |
Participant Flow
| Recruitment Details | 32 participants were accrued from six institutions between 12/2012 and 6/2016 |
| Pre-assignment Details | Of the 32 participants who consented to the study, 5 were determined to be not eligible and 2 withdrew consent prior to starting study treatment |
| Arm/Group Title | Stereotactic Radiosurgery Followed by Erlotinib |
|---|---|
 Arm/Group Description |
Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib Stereotactic Radiosurgery: 21 Gy daily for 5 days Erlotinib: 150mg once daily |
| Period Title: Overall Study | |
| Started | 25 |
| Completed | 25 |
| Not Completed | 0 |
Baseline Characteristics
| Arm/Group Title | Stereotactic Radiosurgery Followed by Erlotinib | |
|---|---|---|
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Arm/Group Description |
Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib Stereotactic Radiosurgery: 21 Gy daily for 5 days Erlotinib: 150mg once daily |
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| Overall Number of Baseline Participants | 25 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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| Number Analyzed | 25 participants | |
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64
(44 to 82)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | |
| Female |
16 64.0%
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| Male |
9 36.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | |
| Hispanic or Latino |
0 0.0%
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| Not Hispanic or Latino |
25 100.0%
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| Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | |
| American Indian or Alaska Native |
0 0.0%
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| Asian |
0 0.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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| Black or African American |
0 0.0%
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| White |
25 100.0%
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| More than one race |
0 0.0%
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| Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 25 participants |
| 25 | ||
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Smoking status
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | |
| Never smoker |
16 64.0%
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| Former smoker |
7 28.0%
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| Unknown |
2 8.0%
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Performance status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | |
| 0, Fully active |
16 64.0%
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| 1, Restricted in strenuous activity but ambulatory |
9 36.0%
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[1]
Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale from 0-5 to describe a patient's level of functioning in terms of self care ability and activity level. Higher on the scale is worse functioning
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Mutation type
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | |
| Exon 19 |
14 56.0%
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| Exon 21 |
7 28.0%
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| Exon 19+ ALK rearrangement |
1 4.0%
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| Exon 18 and Exon 20 |
1 4.0%
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| None proven; met clinical criteria |
2 8.0%
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[1]
Measure Description: The mutation type is the location (Exon) of the mutation in the Epidermal Growth Factor Receptor (EGFR) gene. Subjects who did have proof of a mutation through testing (due to inadequate tissue, for example) were still eligible for the study if they met the clinical criteria of a clinical response overwhelmingly consistent with EGFR mutation (PR plus at least 6 months free of progressive disease as a consequence of EGFR-TKI therapy).
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Charlson Co-morbidity Index
[1] Median (Full Range) Unit of measure: Units on a scale |
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| Number Analyzed | 25 participants | |
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6
(0 to 10)
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[1]
Measure Description: The Charlson Comorbidity Index is a method of categorizing comorbidities of patients in which each category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient ranging from 0 (no comorbidities) to 24. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.
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Outcome Measures
Adverse Events
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.
More Information
Results Point of Contact
| Name/Title: | Robin V. Johnson |
| Organization: | UNC Lineberger Comprehensive Cancer Center |
| Phone: | 919-966-1125 |
| EMail: | Robin_V_Johnson@med.unc.edu |
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01573702 |
| Other Study ID Numbers: |
LCCC 1123 |
| First Submitted: | April 5, 2012 |
| First Posted: | April 9, 2012 |
| Results First Submitted: | September 16, 2020 |
| Results First Posted: | January 12, 2021 |
| Last Update Posted: | January 12, 2021 |