Locally Invasive NSCLC Treated With NEo-Adjuvant Stereotactic Body RadioTherapy and REsection
Information source: Juravinski Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Small-Cell Lung Cancer; Carcinoma
Intervention: Neoadjuvant Stereotactic body radiation (SBRT) (Radiation)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Juravinski Cancer Center Overall contact: Clinical Trials Department Juravinski Cancer Center, Phone: 905-387-9495
Summary
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.
Clinical Details
Official title: Phase I Study: Locally Invasive NSCLC Treated With NEo-Adjuvant Stereotactic Body Radiotherapy and REsection
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Feasibility of SBRT followed by surgery (proportion of patients who can undergo 10 fractions of SBRT followed by Surgery)
Secondary outcome: 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.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). Secondary feasibility outcomes (including accrual rate, consent rate, rates of deviation from scheduled treatment plan, and reasons for delay) Pathological response following neoadjuvant SBRT (proportion of R0, R1 and R2 resections) Pathologic changes associated with neo-adjuvant SBRT with analysis of irradiated tissues
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients will be included if they are aged 18 years or older,
- with biopsy proven NSCLC,
- clinically staged T3-T4 marginally resectable i. e. deemed at risk to achieve
resection (such as invasion of critical mediastinal or hilar structures, nodal
extra-capsular extension, chest wall, vertebral bodies, compromised bronchial stump
margin, based on CT images of the chest).
- Patients also need to be pathologically staged N0-1 disease,
- with an SBRT CTV≤200cm3, based on planning CT images.
- ECOG status is required to be <2 within 4 weeks prior to registration and
- patients must be deemed medically operable by the surgical team.
Exclusion Criteria:
- Patients will be excluded if they are deemed medically inoperable by the surgical
team
- and have a weight loss of ≥10% within 3 months prior to pathological diagnosis.
- Patients will also have no absolute contraindication to RT such as connective tissue
disease, pacemaker-dependent patient with the pacemaker receiving higher than
tolerance dose, had no had previous RT to the current region of the study, that would
result in overlap of RT fields,
- patients must have no plans to receive other local therapy while on study, except at
disease progression,
- patients have not had other malignancy within 2 years prior to the study (other than
non-melanomatous skin cancers)
Locations and Contacts
Clinical Trials Department Juravinski Cancer Center, Phone: 905-387-9495 Additional Information
Starting date: May 2015
Last updated: April 29, 2015
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