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Despite improved staging and operative techniques, the rate of incomplete resection (R1) of NSCLC has remained significant over the last decades. Patients with R1 resection have significantly worse survival compared to those with complete resection (R0).
This is a phase I study that investigates the feasibility and safety of delivering Stereotactic Body Radiotherapy (SBRT) to patients with locally invasive NSCLC (cT3-4, N0-1) who are at risk for incomplete resection.
Twenty patients with NSCLC will be treated with SBRT followed by surgery and appropriate adjuvant therapy. Patients will be divided into groups, of 5 patients each, treated with escalating doses (35, 40, 45 and 50 Gy) in 10 daily fractions.
The primary outcome is the feasibility i.e. the ability to complete safely SBRT and surgery (within 6 weeks). Secondary outcomes include acute and late adverse events, R0/R1/R2 rates and secondary surrogates of feasibility.
If successful, this study will lead to further evaluation of pre-operative SBRT in NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant stereotactic body radiation | Experimental | Single arm study. Four cohorts of 5 patients will undergo neo-adjuvant SBRT for lung cancer. Eligible patients will have operable, borderline resectable lung cancer , they will be treated with SBRT, prior to undergoing surgical resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant Stereotactic body radiation (SBRT) | Radiation | Dose escalation of neo-adjuvant SBRT in operable patients with locally advanced non-small cell lung cancer. The first cohort will be treated with a dose of 35 Gy in 10 fractions, the second cohort will be treated with a dose of 40 Gy in 10 fractions, the third cohort will be treated with a dose of 45 Gy in 10 fractions, the fourth cohort will be treated with a dose of 50 Gy in 10 fractions. The SBRT doses will be escalated only once all patients in the previous cohort will have completed safely their treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of SBRT followed by surgery (proportion of patients who can undergo 10 fractions of SBRT followed by Surgery) | Feasibility of neo-adjuvant SBRT followed by surgery. This will be measured as the proportion of patients who can undergo 10 fractions of SBRT followed by Surgery as scheduled (within 6 weeks from registration). | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Early safety of SBRT-S through collection of serious adverse events (CTCAE version 4.0 grade 3 or higher) from beginning of SBRT to 4 weeks after completion of surgery. | 18 months | |
| Late safety profile of SBRT-S through collection of surgical complication rates assessed at 6 and 18 months post-registration (thus 30 months from opening of the study, assuming it takes 1 year to complete accrual). |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Department Juravinski Cancer Center | Contact | 905-387-9495 | ||
| Naghmeh Isfahanian, MD | Contact | 9053879495 | isfahanian@hhsc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Theodoros Tsakiridis, M.D., Ph.D. | Juravinski Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juravinski Cancer Centre | Recruiting | Hamilton | Ontario | L8V 5C2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28215851 | Derived | Nguyen NA, Isfahanian N, Pond G, Hanna W, Cutz JC, Wright J, Swaminath A, Shargall Y, Chow T, Wierzbicki M, Okawara G, Quan K, Finley C, Juergens R, Tsakiridis T. A Novel Neoadjuvant Therapy for Operable Locally Invasive Non-Small-Cell Lung Cancer. Phase I Study of Neoadjuvant Stereotactic Body Radiotherapy. LINNEARRE I (NCT02433574). Clin Lung Cancer. 2017 Jul;18(4):436-440.e1. doi: 10.1016/j.cllc.2017.01.007. Epub 2017 Jan 31. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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|
Complications recorded include incidence of bronchopleural fistula, esophageal fistula, wound healing complications (dehiscence, infection) and post-operative pulmonary complications). |
| 30 months |
| Secondary feasibility outcomes (including accrual rate, consent rate, rates of deviation from scheduled treatment plan, and reasons for delay) | These include accrual rate, consent rate, rates of deviation from scheduled treatment plan of 6 weeks, and reasons for delay) | 18 months |
| Pathological response following neoadjuvant SBRT (proportion of R0, R1 and R2 resections) | To determine the proportion of R0, R1 and R2 resections after neoadjuvant SBRT. | 18 months |
| Pathologic changes associated with neo-adjuvant SBRT with analysis of irradiated tissues | 18 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |