Locally Invasive NSCLC Treated With NEo-Adjuvant Stereotactic Body RadioTherapy and REsection

NCT ID: NCT02433574

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-01-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Neoadjuvant Stereotactic body radiation (SBRT)

Intervention Type: 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.

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.

Intervention Type: RADIATION

Eligibility 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 <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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Juravinski Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Theo Tsakiridis, M.D., Ph.D., FRCPC

Radiation Oncologist, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theodoros Tsakiridis, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Juravinski Cancer Center

Locations

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Clinical Trials Department Juravinski Cancer Center

Role: CONTACT

905-387-9495

Naghmeh Isfahanian, MD

Role: CONTACT

isfahanian@hhsc.ca

9053879495

Facility Contacts

Theos Tsakiridis, MD PhD

Role: primary

tsakirid@HHSC.CA

905-308-3574 ext. 64704

References

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.

Reference Type: DERIVED

PMID: 28215851 (View on PubMed)

Other Identifiers

LINNEARRE-I

Identifier Type: -

Identifier Source: org_study_id