TerminatedNot applicableNCT03624907

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.

Checked against the public recordLast updated Oct 4, 2021 · Source: ClinicalTrials.gov

StatusTerminated
PhaseNot applicable
U.S. locations2
SponsorUniversity of Florida
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * ≥ 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. Exclusion Criteria: * 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.

04
Study sites

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.

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