Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Randomized Pilot: the safety of the addition of vancomycin to Stereotactic Body Radiotherapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Arm 1 - 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.
干预措施: Vancomycin (Drug)
Arm 1 - 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.
干预措施: Precision hypofractionated radiation (Radiation)
结局指标
主要结局
Randomized Pilot: the safety of the addition of vancomycin to Stereotactic Body Radiotherapy
时间窗: 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).
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点