The first phase of this study was an open label, randomized pilot study. Enrollment for this phase is now complete.
The second phase is a single arm phase 1 safety study. Patients planned to undergo precision hypofractionated radiation to all sites of oligoprogression will receive vancomycin for 1 week before RT and for 1 month after start of RT, and asked to provide stool and blood samples as outlined in the Safety Trial study table.
Patients planned to receive Stereotactic Body Radiotherapy (SBRT) to a biopsy-proven or clinically-suspected NSCLC
Age >18 years' old
Patient capable of giving informed consent
Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration
None
Single group
Vancomycin
Drug125 mg, 4x daily for 5 weeks
Precision hypofractionated radiation
RadiationPatients planned to undergo precision hypofractionated radiation to all sites of oligoprogression and will receive vancomycin for 1 week before RT and for 1 month after start of RT, and asked to provide stool and blood samples as outlined in the Safety Trial study table.
Randomized Pilot: Th1 immune response measured by cytokine expression (IFN gamma).
The primary endpoint is IFN-gamma cytokine expression at Day 30 (+/- 2) collection compared to the pre-radiation level. It will be analyzed using generalized linear mixed models.
Randomized Pilot: the safety of the addition of vancomycin to Stereotactic Body Radiotherapy
The primary safety endpoint is uncontrolled diarrhea, as defined by CTCAE v4.0 \> or = grade 3 (Increase of \>=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL). This will be evaluated during treatment and at 1 month, 3 months, 6 months and 12 months.
Safety Trial: the safety of the addition of vancomycin to precision hypofractionated radiation
Safety Trial: The primary safety endpoint is uncontrolled diarrhea, as defined by CTCAE v5.0 \> or = grade 3 Increase of \>=7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL). This will be evaluated weekly during vancomycin use and RT, at 1 month post-vancomycin, 3 months post-vancomycin, 6 months post-vancomycin and 12 months post-vancomycin.
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