NCT02433574

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

3.2 years

First QC Date

February 4, 2015

Last Update Submit

July 16, 2018

Conditions

Non-Small-Cell Lung CancerCarcinoma

Keywords

radiosurgeryNeoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • 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).

    30 months

  • Secondary feasibility outcomes (including accrual rate, consent rate, rates of deviation from scheduled treatment plan, and reasons for delay)

    18 months

  • Pathological response following neoadjuvant SBRT (proportion of R0, R1 and R2 resections)

    18 months

  • Pathologic changes associated with neo-adjuvant SBRT with analysis of irradiated tissues

    18 months

Study Arms (1)

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.

Radiation: Neoadjuvant Stereotactic body radiation (SBRT)

Interventions

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.

Neoadjuvant stereotactic body radiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \<R0 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28215851DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Theodoros Tsakiridis, M.D., Ph.D.

    Juravinski Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Department Juravinski Cancer Center

CONTACT

905-387-9495

Naghmeh Isfahanian, MD

CONTACT

9053879495isfahanian@hhsc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist, Associate Professor

Study Record Dates

First Submitted

February 4, 2015

First Posted

May 5, 2015

Study Start

November 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations

CA(1)