A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer

Not Applicable

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Radiation: Stereotactic Body Radiation Therapy plus Surgery

• Registration Number: NCT02136355
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

Stereotactic ablative radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment.

The study combines SABR and surgery to treat non-small cell lung cancer. SABR will be done first, with surgery done approximately 10 weeks later. There will be some extra imaging done before and after the SABR.

The purpose of this study is to determine how effective SABR is in killing the cancer cells, and if SABR can help make surgery more effective.

Detailed Description

The advent of stereotactic ablative radiotherapy (SABR) has provided a novel, promising treatment for patients with early-stage non-small cell lung cancer. SABR uses modern radiotherapy planning and targeting technologies to precisely deliver larger, ablative doses of radiotherapy.

The use of SABR as neoadjuvant therapy prior to surgery may provide a novel therapeutic opportunity. In oncology, the use of neoadjuvant radiotherapy or chemoradiotherapy prior to surgery has become widespread for several types of cancer, and in many instances improves local control over and/or survival compared to surgery alone. Neoadjuvant radiotherapy provides several theoretical advantages, including potentially decreasing the rate of positive margins, decreasing the size of the required resection, or by sterilizing the tumor to avoid seeding of circulating tumor cells during surgery. Although radiologic outcomes after SABR illustrate local control rates of approximately 90% in many studies, the presence of residual post-treatment fibrosis may confound this assessment of recurrence.

The goal of this study is to evaluate a novel treatment approach: the combination of neoadjuvant SABR followed by surgical resection in patients with T1T2N0 non-small cell lung cancer, in order to measure the true pathologic rates of local control after SABR, to develop new imaging biomarkers or response, and to assess clinical outcomes, including toxicity, relapse patterns, and survival.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-13
• Study Start: 2014-09
• Primary Completion: 2022-11-25
• Study Completion: 2022-11-25
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age 18 or older
• Willing to provide informed consent
• Histologically confirmed non-small cell lung cancer
• Tumor stage T1 or T2a (less than or equal to 5 cm)
• No evidence of nodal disease (N0)
• No evidence of distant metastases (M0)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy > 6 months
• Adequate forced expiratory volume at one second (FEV1), defined as a predicted post-operative FEV1 of 30% or greater

Read More

Exclusion Criteria

• Serious medical comorbidities or other contraindications to radiotherapy or surgery
• Prior history of lung cancer within 5 years
• Prior thoracic radiation at any time
• Inability to attend full course of radiotherapy, surgery, or follow-up visits
• Contrast allergy
• Pregnant or lactating women

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Body Radiation Therapy plus Surgery	Stereotactic Body Radiation Therapy plus Surgery	Stereotactic body radiation therapy followed by surgical resection

Primary Outcome Measures

Name	Time	Method
Tumor response	2.5 years	Percentage of patients who exhibit a lack of viable tumor after surgical resection

Secondary Outcome Measures

Name	Time	Method
Predictive value of imaging biomarkers	2.5 years	Predictive value of novel imaging biomarkers compared to pathologic outcome (complete response or non-complete response to treatment)
Tumor recurrence	7 years	Time to local recurrence, regional recurrence, and distant recurrence of disease will be measured
Toxicity of the combined approach of SABR + surgery	7 years	Toxicity of the combined approach of SABR plus surgical resection will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Quality of life measures , including physical well-being, functional well-being, and lung-cancer subscale questions	7 years	The FACT-TOI is a summary score derived from the FACT-L and is composed of 21 items, including physical well-being, functional well-being, and lung-cancer subscale questions

Trial Locations

Locations (1)

London Regional Cancer Program of the Lawson Health Research Institute; 🇨🇦 London, Ontario, Canada