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

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.


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 which included immunotherapy * the number of sites of progression are \< 5 sites. * age \>18 years' old * patient capable of giving informed consent safety trial exclusion * evidence of 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 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 * 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 * use of probiotics during the 4 weeks prior to radiotherapy or during radiotherapy