A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer
Conditions
Non Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Stereotactic Body Radiation Therapy plus Surgery
Type: Radiation
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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

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
Location
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada
Status: Recruiting
Start Date
September 2014
Completion Date
September 2021
Sponsors
Lawson Health Research Institute
Source
Lawson Health Research Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page