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

Official Title

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

Summary:

Stereotactic ablative radiation therapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumours 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.

Trial Description

Primary Outcome:

  • Tumour response
Secondary Outcome:
  • Predictive value of imaging biomarkers
  • Tumour recurrence
  • Toxicity of the combined approach of SABR + surgery
  • Quality of life
The advent of stereotactic ablative radiation therapy (SABR) has provided a novel, promising treatment for patients with early-stage non-small cell lung cancer. SABR uses modern radiation therapy planning and targeting technologies to precisely deliver larger, ablative doses of radiation therapy. The use of SABR as neoadjuvant therapy prior to surgery may provide a novel therapeutic opportunity. In oncology, the use of neoadjuvant radiation therapy 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 radiation therapy provides several theoretical advantages, including potentially decreasing the rate of positive margins, decreasing the size of the required resection, or by sterilizing the tumour to avoid seeding of circulating tumour 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society