CSP #2005 - Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial (VALOR)
VA Office of Research and Development
Summary
Patients with stage I non-small cell lung cancer have been historically treated with surgery whenever they are fit for an operation. However, an alternative treatment known as stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors believe both are good treatments and are therefore conducting this study to determine if one may be possibly better than the other.
Description
The standard of care for stage I non-small cell lung cancer has historically been surgical resection in patients who are medically fit to tolerate an operation. Recent data now suggests that stereotactic radiotherapy may be a suitable alternative. This includes the results from a pooled analysis of two incomplete phase III studies that reported a 15% overall survival advantage with stereotactic radiotherapy at 3 years. While these data are promising, the median follow-up period was short, the results underpowered, and the findings were in contradiction to multiple retrospective studies that de…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Inclusion Criteria for Screening * Age 18 or older * Any patient with a preliminary diagnosis of stage I Non-Small Cell Lung Cancer (NSCLC), whether pathologically proven by biopsy, or highly suspicious by radiographic imaging. \[Participants will ultimately need biopsy confirmation before enrolling\] * Primary tumor size less than or equal to 5 cm by CT (may include CT images from PET/CT) * Karnofsky performance status greater than or equal to 70 * Participant has willingness and ability to provided informed consent for participation Inclusion Criteria for Randomization…
Interventions
- RadiationStereotactic Radiotherapy
Stereotactic radiotherapy uses high doses of ionizing energy to treat cancer cells with image guidance. The treatment is delivered in an outpatient setting, and for purposes of this trial is delivered in 3-5 fractions.
- ProcedureAnatomic Pulmonary Resection
An anatomic pulmonary resection is an oncologic procedure that dissects out an anatomically defined segment of the lung to remove all of the lung tissue around a lung tumor. It requires an operation with general anesthesia, with a short hospital stay. The procedure entails removal of lymph nodes inside the chest that might not be easily accessible without an operation.
Locations (17)
- VA Long Beach Healthcare System, Long Beach, CALong Beach, California
- VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los Angeles, California
- Bay Pines VA Healthcare System, Pay Pines, FLBay Pines, Florida
- Miami VA Healthcare System, Miami, FLMiami, Florida
- Edward Hines Jr. VA Hospital, Hines, ILHines, Illinois
- Richard L. Roudebush VA Medical Center, Indianapolis, INIndianapolis, Indiana