Non Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer
Verified date | March 2023 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 25, 2022 |
Est. primary completion date | November 25, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | London Regional Cancer Program of the Lawson Health Research Institute | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor response | Percentage of patients who exhibit a lack of viable tumor after surgical resection | 2.5 years | |
Secondary | Predictive value of imaging biomarkers | Predictive value of novel imaging biomarkers compared to pathologic outcome (complete response or non-complete response to treatment) | 2.5 years | |
Secondary | Tumor recurrence | Time to local recurrence, regional recurrence, and distant recurrence of disease will be measured | 7 years | |
Secondary | Toxicity of the combined approach of SABR + surgery | 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. | 7 years | |
Secondary | Quality of life measures , including physical well-being, functional well-being, and lung-cancer subscale questions | 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 | 7 years |
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