Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer
- Conditions
- Early Stage Non-Small Cell Lung Cancer
- Interventions
- Radiation: Precision hypofractionated radiation
- Registration Number
- NCT03546829
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 - Experimental Vancomycin 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. Arm 1 - Experimental Precision hypofractionated radiation 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.
- Primary Outcome Measures
Name Time Method Randomized Pilot: the safety of the addition of vancomycin to Stereotactic Body Radiotherapy 2 years 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.
Randomized Pilot: Th1 immune response measured by cytokine expression (IFN gamma). 2 years 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.
Safety Trial: the safety of the addition of vancomycin to precision hypofractionated radiation 3 years 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States