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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

Page last updated: August 23, 2015

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