Daily vs. Non-Daily SBRT for NSCLC

Stopped early · Not applicable

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT03624907

Run by

University of Florida

People needed

20

Starts

2018-10-19

Expected to finish

2021-06-16

Last updated by the study team

2021-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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.

You may not qualify if…

• 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.

Where it is running

• Department of Radiation Oncology Davis Cancer Pavilion — Gainesville, Florida, United States
• University of Florida Health Proton Therapy Institute — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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