Locally Invasive NSCLC Treated With NEo-Adjuvant Stereotactic Body RadioTherapy and REsection (LINNEARRE-I)
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|ClinicalTrials.gov Identifier: NCT02433574|
Recruitment Status : Recruiting
First Posted : May 5, 2015
Last Update Posted : July 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small-Cell Lung Cancer Carcinoma||Radiation: Neoadjuvant Stereotactic body radiation (SBRT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study: Locally Invasive NSCLC Treated With NEo-Adjuvant Stereotactic Body Radiotherapy and REsection|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Experimental: Neoadjuvant stereotactic body radiation
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.
Radiation: Neoadjuvant Stereotactic body radiation (SBRT)
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.
- Feasibility of SBRT followed by surgery (proportion of patients who can undergo 10 fractions of SBRT followed by Surgery) [ Time Frame: 18 months ]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).
- 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. [ Time Frame: 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). [ Time Frame: 30 months ]Complications recorded include incidence of bronchopleural fistula, esophageal fistula, wound healing complications (dehiscence, infection) and post-operative pulmonary complications).
- Secondary feasibility outcomes (including accrual rate, consent rate, rates of deviation from scheduled treatment plan, and reasons for delay) [ Time Frame: 18 months ]These include accrual rate, consent rate, rates of deviation from scheduled treatment plan of 6 weeks, and reasons for delay)
- Pathological response following neoadjuvant SBRT (proportion of R0, R1 and R2 resections) [ Time Frame: 18 months ]To determine the proportion of R0, R1 and R2 resections after neoadjuvant SBRT.
- Pathologic changes associated with neo-adjuvant SBRT with analysis of irradiated tissues [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433574
|Contact: Clinical Trials Department Juravinski Cancer Center||905-387-9495|
|Contact: Naghmeh Isfahanian, MDemail@example.com|
|Juravinski Cancer Centre||Recruiting|
|Hamilton, Ontario, Canada, L8V 5C2|
|Contact: Theos Tsakiridis, MD PhD 905-308-3574 ext 64704 tsakirid@HHSC.CA|
|Principal Investigator:||Theodoros Tsakiridis, M.D., Ph.D.||Juravinski Cancer Center|