Recruiting

SBRT & Resection

Sponsor:

Juravinski Cancer Center

Code:

NCT02433574

Conditions

Non-Small-Cell Lung Cancer

Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Neoadjuvant Stereotactic body radiation (SBRT)

Study Details

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.

Conditions

Non-Small-Cell Lung Cancer

Carcinoma

Study ID

NCT02433574

Start date

Nov, 2015

Status verified date

Jul, 2018

Completion date

Jan, 2019

Anticipated

Primary completion date

Jan, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 <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.

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)

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Feasibility of SBRT followed by surgery (proportion of patients who can undergo 10 fractions of SBRT followed by Surgery) [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Department Juravinski Cancer Center

905-387-9495

Naghmeh Isfahanian, MD

9053879495isfahanian@hhsc.ca

Locations

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Theos Tsakiridis, MD PhD

905-308-3574tsakirid@HHSC.CA

More Information

Sponsor

Juravinski Cancer Center

Last update posted

Jul 17, 2018

Last verified

Jul, 2018

Keywords

  • radiosurgery
  • Neoadjuvant Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Juravinski Cancer Center on 2018-07-17.