(PRESTO) A Randomized Phase II Trial Evaluating Hotspots in Stereotactic Ablative Radiotherapy for Early-Stage Non-Small Cell Lung Cancer
Roswell Park Cancer Institute
Summary
This clinical trial compares stereotactic ablative radiotherapy (SBRT) with hot spots to standard of care SBRT for the treatment of patients with early-stage non-small cell lung cancer. SBRT with hot spots intentionally makes sure the tumor gets a higher radiation dose during treatment. This potentially may result in better control of the tumor, but also more side effects. SBRT with or without hot spots may be more effective in treating patients with early-stage non-small cell lung cancer, compared to standard of care SBRT.
Description
PRIMARY OBJECTIVE: I. Evaluate the impact of incorporating high isodoses termed "hot spots" in radiation therapy planning on local control. SECONDARY OBJECTIVES: I. Evaluate the impact of "hot spots" in radiation therapy planning on progression-free survival (PFS). II. Evaluate the impact of "hot spots" in radiation therapy planning on overall survival (OS). III. Evaluate the impact of tumor size on local control and if hotspot grouping impacts local control in a size-dependent manner. IV. To prospectively evaluate the PFS in early stage-non small cell lung cancer (ES-NSCLC) patients und…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years * Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Diagnosed with T1-3N0 biopsy-proven NSCLC of the lung. Multiple primary lung tumors are allowed; however, each lesion requires histologic confirmation * Metachronous lung tumors as defined as a new lung lesion in the setting of a historically treated lung cancer are allowed under certain conditions. The previous lung cancer must have been treated greater than 6 months prior to protocol therapy and this cancer must be considered controlled * Eligible for SABR * Participants of c…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureLymph Node Biopsy
Undergo lymph node sampling
- ProcedurePositron Emission Tomography
Undergo PET scan
- RadiationStereotactic Body Radiation Therapy
Receive SOC SBRT
- RadiationStereotactic Body Radiation Therapy
Receive hot spot SBRT
- OtherSurvey Administration
Location
- Roswell Park Cancer InstituteBuffalo, New York