Daily vs. Non-Daily SBRT for NSCLC
The purpose of this study is to determine if stereotactic body radiotherapy (SBRT) on non-consecutive days will increase the chances of curing non-small cell lung cancer when compared to daily treatment.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 4, 2021 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- University of Florida
- Interventions being studied
- Radiation: Daily Stereotactic Body Radiotherapy; Radiation: Non-Daily Stereotactic Body Radiotherapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- ≥ 18 years of age (no upper age limit).
- A diagnosis of non-small cell lung cancer, T1-2 N0 M0 either with histologic confirmation or with documented interval growth of the index lesion on two interval computed tomography (CT) chest scans and an SUVmax of the lesion ≥ 3.0 on a pretreatment PET scan.
- Patient must be deemed medically inoperable or refuse surgery.
- Radiographic evaluation of the mediastinum and distant sites with a CT scan of the chest and PET scan.
- For T2b N0 patients, radiographic evaluation of the brain with magnetic resonance imaging (MRI) of the brain unless the patient has contraindications to an MRI scan (in which case a CT scan of the head is necessary).
- For central T1 N0 and all T2 N0 patients, pathologic sampling (either via endobronchial ultrasound-guided biopsy \[EBUS\] or mediastinoscopy) of mediastinal lymph nodes is required.
- ECOG Performance Status 0-2.
- For women of childbearing potential, negative pregnancy test within 2 weeks prior to SBRT treatment.
- Patients must be deemed able to comply with the treatment plan and follow-up schedule.
- Patients must provide specific informed consent prior to study entry.
- Women of childbearing potential and male participants who are sexually active must use adequate contraception during treatment and for 6 weeks following treatment.
- Prior history of radiation therapy to the thorax that would likely increase the risk of serious complications from the radiotherapy delivered on this protocol.
- Prior history of lung cancer.
- Currently taking disease-modifying rheumatoid drugs (DMRDs).
- Severe, active co-morbidity, defined as follows:
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. Note, however, that coagulation parameters are not required for entry into this protocol.
- Prior organ transplant.
- Systemic lupus.
- Psoriatic arthritis.
- Known to be HIV positive. HIV-positive patients are known to have worse clinical outcomes, especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Department of Radiation Oncology Davis Cancer PavilionGainesville, Florida
- University of Florida Health Proton Therapy InstituteJacksonville, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 4, 2021. Always confirm current availability with the study team.