Safety Trial of Antimicrobial Therapy and Precision Radia... | NCT03546829

ID	Type	Description	Link
827551	Other Identifier	University of Pennsylvania IRB

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1 - Experimental	Experimental	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.	Drug: Vancomycin Radiation: Precision hypofractionated radiation

Name	Type	Description	Arm Group Labels	Other Names
Vancomycin	Drug	125 mg, 4x daily for 5 weeks	Arm 1 - Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	2 years
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.	2 years
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.	3 years

Eligibility Module

Eligibility Criteria

Randomized Pilot Inclusion

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

Randomized Pilot Exclusion

Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration
Active infection with oral temperature >100°F
Use of corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration
Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S4).
Documented history of HIV, HBV or HCV
Active uncontrolled gastrointestinal disorders such as inflammatory bowel disease, moderate/severe irritable bowel syndrome, persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium Difficile infection (within 2 years of lung cancer diagnosis) or Helicobacter Pylori infection (untreated)
Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time
Patients on anti-diarrheal medications
Patients on probiotics

Safety Trial Inclusion

Patients planned to receive precision hypofractionated radiation (SBRT or an ablative dose of radiation is used if SBRT is not appropriate or if insurance does not approve - i.e. > 30 Gy in 10 fraction equivalent) to all sites of oligoprogressive NSCLC who progressed after 1st line systemic therapy for metastatic disease which included immunotherapy or a tyrosine kinase inhibitors (TKI) for NSCLC
The number of sites of progression are < 5 sites.
Age >18 years' old
Patient capable of giving informed consent

Safety Trial Exclusion

Evidence of untreated CNS or leptomeningeal disease
Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration
Active infection with oral temperature >100°F
Use of oral corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration
Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S3).
Documented history of HIV, HBV or HCV
Patients on daily anti-diarrheal medications
Use of probiotics during the 4 weeks prior to radiotherapy or during radiotherapy

Name	Role	Phone	Extension	Email
Ching Lai	Contact	267-250-9244		ching.lai@pennmedicine.upenn.edu
RadOnc Clinical Research Unit	Contact			radonccru@pennmedicine.upenn.edu

Name	Affiliation	Role
Steven Feigenberg, MD	University of Pennsylvania	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania	Recruiting	Philadelphia	Pennsylvania	19104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40639850	Derived	Feigenberg SJ, Costabile F, Tanes C, Bittinger K, O'Connor R, Agarwal D, Skoufos G, Salaris S, Hatzigeorgiou A, Kostopoulos N, Lloyd S, Friedes C, Chen L, Yegya-Raman N, Cengel K, Levin W, Valentic B, Quarton T, Shestov AA, Berman A, Bradley J, Maity A, Koumenis C, Ben-Josef E, Facciabene A. Enhancing outcomes in medically inoperable early-stage NSCLC with gut-targeted antibiotics and stereotactic body radiotherapy: results from a randomized pilot study. J Immunother Cancer. 2025 Jul 10;13(7):e011356. doi: 10.1136/jitc-2024-011356.

ID	Term
D006020	Glycopeptides
D006001	Glycoconjugates
D002241	Carbohydrates
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins