Chemoradiotherapy + Atezolizumab for Bladder Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, certain medications like systemic chemotherapy, immunotherapy not specified in the protocol, and some vaccines are not allowed during the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
What data supports the effectiveness of the drug Atezolizumab when used with chemoradiotherapy for bladder cancer?
Research shows that combining platinum-based chemotherapy with radiation therapy can be effective for locally advanced bladder cancer, with a high rate of complete response and survival benefits. Neoadjuvant cisplatin-based chemotherapy has also been shown to improve survival in patients with metastatic bladder cancer, suggesting potential benefits when combined with other treatments like Atezolizumab.12345
Is the combination of chemoradiotherapy and atezolizumab safe for bladder cancer treatment?
The combination of chemoradiotherapy and atezolizumab for bladder cancer has been studied for safety. Atezolizumab is generally well-tolerated, even in patients with kidney issues, and is expected to work well with radiation therapy. Cisplatin, a component of chemoradiotherapy, can cause side effects like nausea and bone marrow suppression, but these are usually manageable.678910
What makes the treatment of chemoradiotherapy plus atezolizumab unique for bladder cancer?
This treatment combines chemoradiotherapy with atezolizumab, an immune therapy that helps the body's immune system attack cancer cells, offering a bladder-preserving option for patients who cannot undergo surgery. Atezolizumab is unique because it targets PD-L1, a protein that helps cancer cells evade the immune system, and is particularly beneficial for patients who are not eligible for traditional cisplatin chemotherapy.911121314
What is the purpose of this trial?
This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.
Research Team
Parminder Singh
Principal Investigator
SWOG Cancer Research Network
Eligibility Criteria
Adults with localized muscle invasive bladder cancer who've had a recent tumor removal and imaging, can participate. They must not have small cell carcinoma or certain other cancers in the last 24 months, no prior pelvic radiation or systemic chemotherapy for bladder cancer, and no severe liver disease or active infections. HIV-positive patients on stable treatment are eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo radiation therapy and receive chemotherapy with or without atezolizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Atezolizumab
- Cisplatin
- Fluorouracil
- Gemcitabine
- Mitomycin
- Radiation Therapy
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor