Use of High Dose Radiation Followed by Chemotherapy and Radiation to Treat Locally Advanced NSCLC
Phase 2
Active, not recruiting
NCT03141359
| Condition | Lung Cancer Stage II, Lung Cancer Stage III, Non Small Cell Lung Cancer |
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| Phase | Phase 2 |
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| Sponsor | Wake Forest University Health Sciences |
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| Status | Active, not recruiting |
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| Enrollment | 61 participants |
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| Interventions | SBRT, Carboplatin, Paclitaxel, cis Platinum, Etoposide |
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| Start date | May 12, 2017 |
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| Completion date | Jul 12, 2023 |
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| Results posted | Aug 29, 2024 |
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Summary
This is a single-arm, single-stage Phase II study designed to evaluate the 1-year PFS rate in subjects with locally-advanced NSCLC (stage II/III) and treated with Stereotactic Body Radiation Therapy (SBRT) followed by concurrent mediastinal chemoradiation with or without consolidation chemotherapy. A total of 60 subjects will be enrolled to this study over a 4 year accrual period.
Number of Participants Progression Free and Surviving at 12 Months
From date of treatment start to date of progression or death, or censored at 12 months, whichever occurred first. · Participants
| SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy | 37 Participants |
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| p-value | .388 |
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| Rate | 0.627 (95% CI 0.492–0.750) |
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Open in BENITIONS
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