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.
Condition or disease
Early Stage Non-Small Cell Lung Cancer
Intervention/treatment
Vancomycin
Precision hypofractionated radiation
| Study Type : |
INTERVENTIONAL |
| Estimated Enrollment : |
10 participants |
| Masking : |
NONE |
| Primary Purpose : |
TREATMENT |
| Official Title : |
Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer |
| Actual Study Start Date : |
2019-03-05 |
| Estimated Primary Completion Date : |
2027-12-31 |
| Estimated Study Completion Date : |
2028-12-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: |
18 Years
|
| Sexes Eligible for Study: |
ALL |
| Accepts Healthy Volunteers: |
|
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 consentRandomized 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 probioticsSafety 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 consentSafety 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