What this study is
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.
What's being tested
- Biospecimen Collection
Intervention · PROCEDURE
Undergo blood sample collection
- Computed Tomography
Intervention · PROCEDURE
Undergo CT scan
- Lymph Node Biopsy
Intervention · PROCEDURE
Undergo lymph node sampling
- Positron Emission Tomography
Intervention · PROCEDURE
Undergo PET scan
- Stereotactic Body Radiation Therapy
Intervention · RADIATION
Receive SOC SBRT
- Stereotactic Body Radiation Therapy
Intervention · RADIATION
Receive hot spot SBRT
- Survey Administration
Intervention · OTHER
Ancillary studies
Study details
- Official title
- (PRESTO) A Randomized Phase II Trial Evaluating Hotspots in Stereotactic Ablative Radiotherapy for Early-Stage Non-Small Cell Lung Cancer
- Sponsor
- Roswell Park Cancer Institute
- Conditions
- Early Stage Lung Non-Small Cell Carcinoma · Stage I Lung Cancer AJCC v8 · Stage II Lung Cancer AJCC v8
- Enrolling
- 200 people
- Starts
- 2026-12-01
- Est. completion
- 2029-09-01
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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 child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
You can't join if
- Patients with a history of a prior lung cancer will be excluded only if the previous treatment is within 6 months of the protocol therapy
- Mixed small cell and non-small cell lung cancer
- History of allogeneic organ transplantation
- History of primary immunodeficiency
- Patients must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment
- Active autoimmune disease that has required systemic treatment in the last 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
- Known EGFR or ALK mutation
- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- Pregnant or nursing female participant
- Unwilling or unable to follow protocol requirements
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRoswell Park Cancer Institute
Buffalo, New York, United States
- ASK Roswell · Contact800-767-9355AskRoswell@Roswellpark.org
- Mark Farrugia · Principal investigator
Recruiting
Study team
Sponsor
Roswell Park Cancer Institute
Study ID I-4050824
Principal investigator
Mark Farrugia
Roswell Park Cancer Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.