Antimicrobial Therapy + SBRT for Lung Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Abramson Cancer Center at Penn Medicine
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests if adding the antibiotic vancomycin to a precise radiation therapy can enhance the immune response in cancer patients by increasing certain immune signals.
Will I have to stop taking my current medications?
You may need to stop taking certain medications, such as antibiotics, antifungals, antivirals, antiparasitics, corticosteroids, methotrexate, immunosuppressive drugs, chemotherapy, anti-diarrheal medications, and probiotics, at least 4 weeks before joining the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy (SBRT) for lung cancer?
Research shows that Stereotactic Body Radiation Therapy (SBRT) is effective for treating early-stage non-small cell lung cancer (NSCLC), especially for patients who cannot or choose not to have surgery. Studies indicate that SBRT can improve survival rates and control the cancer locally.
12345Is the combination of antimicrobial therapy and SBRT generally safe for humans?
Stereotactic Body Radiation Therapy (SBRT) is generally well-tolerated for lung cancer, but it can cause side effects like fatigue, esophagitis (inflammation of the esophagus), pneumonitis (lung inflammation), and rib fractures. These side effects vary in severity, and efforts are ongoing to better understand and reduce them.
16789How is the treatment of Stereotactic Body Radiation Therapy (SBRT) for lung cancer different from other treatments?
Stereotactic Body Radiation Therapy (SBRT) is unique because it delivers highly focused radiation doses to lung tumors with precision, minimizing damage to surrounding healthy tissue. This makes it particularly suitable for patients with early-stage non-small cell lung cancer (NSCLC) who cannot undergo surgery, offering high local control rates with acceptable side effects.
110111213Eligibility Criteria
This trial is for adults who can consent and are set to receive SBRT for confirmed NSCLC. It's not open to those with chronic constipation, recent use of steroids or immunosuppressants, antibiotics, antifungals, antivirals, or chemotherapy. People with uncontrolled GI disorders, certain infections or a history of major GI surgery aren't eligible.Inclusion Criteria
I am scheduled for targeted radiation therapy for my lung cancer.
I am 18 years old or older.
Exclusion Criteria
I currently have a fever over 100Β°F.
I am currently taking medication for diarrhea.
I have a documented history of HIV, hepatitis B, or hepatitis C.
I am currently taking probiotics.
I have chronic constipation, with bowel movements less frequent than every other day.
Participant Groups
The study tests if adding vancomycin (an antibiotic) to SBRT boosts the Th1 immune response in early-stage non-small cell lung cancer patients by measuring specific immune signals like IFN gamma after treatment.
1Treatment groups
Experimental Treatment
Group I: Arm 1 - ExperimentalExperimental Treatment2 Interventions
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.
Stereotactic Body Radiation Therapy (SBRT) is already approved in United States, European Union, Canada, Japan for the following indications:
πΊπΈ Approved in United States as Stereotactic Body Radiation Therapy for:
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
- Spinal tumors
πͺπΊ Approved in European Union as Stereotactic Body Radiation Therapy for:
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
- Spinal tumors
π¨π¦ Approved in Canada as Stereotactic Body Radiation Therapy for:
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
- Spinal tumors
π―π΅ Approved in Japan as Stereotactic Body Radiation Therapy for:
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
- Spinal tumors
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of PennsylvaniaPhiladelphia, PA
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, PA
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Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
References
Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer: A Retrospective, Single-Center Study of 55 Patients. [2018]Purpose/Objective(s): Stereotactic body radiation therapy (SBRT) is an effective treatment for patients with early-stage non-small cell lung cancer (NSCLC) who are not surgical candidates or who refuse surgical management. In this study, we report on our clinical outcomes and toxicity in the treatment of early-stage NSCLC with SBRT.
Lung Stereotactic Body Radiation Therapy. [2018]Lung stereotactic body radiation therapy (SBRT) is a novel and effective modality for treatment of early stage non-sail cell lung cancer (NSCLC), with expanding indications in locally advanced and metastatic disease. Herein, we will review current treatment recommendations for early stage NSCLC, detail treatment planning of SBRT, and discuss future directions.
The impact of histology in the outcomes of patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic body radiation therapy (SBRT) and adjuvant chemotherapy. [2021]Stereotactic body radiation therapy (SBRT) is the standard of care treatment for nonsurgical patients with early-stage non-small cell lung cancer (NSCLC). A recent report has indicated an improvement in overall survival (OS) with adjuvant chemotherapy in patients with tumors β₯ 4 cm treated with SBRT. We present a retrospective study evaluating the impact of histology in patients treated with SBRT and adjuvant chemotherapy.
Dose-response for stereotactic body radiotherapy in early-stage non-small-cell lung cancer. [2022]To compare the efficacy of three lung stereotactic body radiotherapy (SBRT) regimens in a large institutional cohort.
Local control and survival after stereotactic body radiation therapy of early-stage lung cancer patients in Slovenia. [2023]Stereotactic body radiation therapy (SBRT) precisely and non-invasively delivers ablative radiation dose to tumors in early-stage lung cancer patients who are not candidates for surgery or refuse it. The aim of research was to evaluate local control, overall survival (OS), local progression free survival (LPFS), distant metastases free survival (DMFS), disease free survival (DFS) and toxicity in early-stage lung cancer patients treated with SBRT in a single tertiary cancer centre.
The evolving toxicity profile of SBRT for lung cancer. [2023]Stereotactic body radiation therapy (SBRT) is an effective and well tolerated treatment for early stage non-small cell lung cancer (NSCLC). The high doses used in thoracic SBRT can sometimes cause adverse effects ranging from mild fatigue and transient esophagitis to fatal events such as pneumonitis or hemorrhage. Efforts continue to expand in both the utility of this technique as well as our understanding of the mechanisms of the adverse effects it can cause. In this review, we discuss the current literature regarding the potential mechanisms, dosimetric constraints and toxicities associated with SBRT alone and in conjunction with definitive chemoradiotherapy and immunotherapy. As the use of SBRT expands to these spheres, we examine the available recommendations for mitigating potential associated treatment related toxicities.
Rib fracture after stereotactic radiotherapy for primary lung cancer: prevalence, degree of clinical symptoms, and risk factors. [2021]As stereotactic body radiotherapy (SBRT) is a highly dose-dense radiotherapy, adverse events of neighboring normal tissues are a major concern. This study thus aimed to clarify the frequency and degree of clinical symptoms in patients with rib fractures after SBRT for primary lung cancer and to reveal risk factors for rib fracture. Appropriate Ξ±/Ξ² ratios for discriminating between fracture and non-fracture groups were also investigated.
Organs at Risk Considerations for Thoracic Stereotactic Body Radiation Therapy: What Is Safe for Lung Parenchyma? [2022]Stereotactic body radiation therapy (SBRT) has become the standard of care for inoperable early-stage non-small cell lung cancer and is often used for recurrent lung cancer and pulmonary metastases. Radiation-induced lung toxicity (RILT), including radiation pneumonitis and pulmonary fibrosis, is a major concern for which it is important to understand dosimetric and clinical predictors.
Pathological vertebral fracture after stereotactic body radiation therapy for lung metastases. Case report and literature review. [2022]Stereotactic body radiation therapy (SBRT) is a radiation technique used in patients with oligometastatic lung disease. Lung and chest wall toxicities have been described in the patients but pathological vertebral fracture is an adverse effect no reported in patients treated with SBRT for lung metastases.
Stereotactic body radiotherapy (SBRT) for Stage I lung cancer. [2018]Stereotactic body radiation therapy (SBRT) is a newly developed technique currently in clinical use. SBRT originated from stereotactic radiosurgery (SRS) for intracranial tumors. Since the 1990s, SBRT has been widely used in clinical settings for the treatment of lung cancer. We review the history and current standard techniques. Previous clinical studies of lung cancer showed high local control rates with acceptable toxicities. Past and on-going clinical trials are also reviewed.
An optimal dose-fractionation for stereotactic body radiotherapy in peripherally, centrally and ultracentrally located early-stage non-small lung cancer. [2023]Stereotactic body radiotherapy (SBRT), also known as stereotactic ablative radiotherapy (SABR), is commonly used in inoperable patients with early-stage non-small lung cancer (NSCLC). This treatment has good outcomes and low toxicity in peripherally located tumors. However, in lesions which are located close to structures such as the bronchial tree or mediastinum the risk of severe toxicity increases. This review summarizes the evidence of dose-fractionation in SBRT of NSCLC patients in various locations.
Undetected lymph node metastases in presumed early stage NSCLC SABR patients. [2017]Stereotactic body radiation therapy (SBRT, also called stereotactic ablative body radiation SABR) is the treatment of choice for many patients with early-stage non-small cell lung cancer (NSCLC), including those who are unfit for surgery or refuse surgery.
Stereotactic body radiotherapy for early stage lung cancer. [2021]Stereotactic body radiation therapy (SBRT) is a newly developed technique currently in clinical use. SBRT originated from stereotactic radiosurgery for intracranial tumors. SBRT has been widely used clinically for lung cancer. The practice of SBRT demands different kinds of patient fixation, breathing control, target determination, treatment planning, and verifications. The history and current standard technique are reviewed. Clinical studies of lung cancer showed high local control rates with acceptable toxicities. Past and on-going clinical trials are reviewed.