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Tests treatment safety and results for Early Stage Non-Small Cell Lung Cancer
Official title Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT03546829
What this study is testing
What is Vancomycin?
Vancomycin is an investigational medicine, given as an once-daily, being studied as a potential treatment for early stage non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The first phase of this study was an open label, randomized pilot study. Enrollment for this phase is now complete.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- assigned by chance 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 assigned by chance Pilot Exclusion
- Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration
See the full eligibility criteria
- assigned by chance 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 assigned by chance 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.