Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer

Conditions

• Bladder Urothelial Carcinoma
• Muscle Invasive Bladder Carcinoma
• Stage II Bladder Cancer AJCC v8
• Stage IIIA Bladder Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Given IV
• Biopsy of Bladder — PROCEDURE
  Undergo a bladder biopsy
• Cisplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT or MRI
• Cystoscopy — PROCEDURE
  Undergo a cystoscopy
• Fluorouracil — DRUG
  Given IV
• Gemcitabine — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo CT or MRI
• Mitomycin — DRUG
  Given IV
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Radiation Therapy — RADIATION
  Undergo 3DCRT or IMRT
• Survey Administration — OTHER
  Ancillary studies
• Transurethral Resection of Bladder Tumor — PROCEDURE
  Undergo a TURBT

Study Details

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.

Key Dates

Start date

Jun 3, 2019

Status verified

Feb 2026

Primary completion

Jun 1, 2027

Completion

Jun 1, 2027

Study Design

Enrollment

475 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (RT, chemotherapy)
  Patients undergo RT (3DCRT or IMRT) daily Monday-Friday for up to 7-8 weeks. Patients also receive chemotherapy based on physician's choice of gemcitabine IV twice weekly for 6 weeks concurrent with RT, or cisplatin IV weekly for 6 weeks concurrent with RT, or fluorouracil IV on same days as doses 1-5 and 16-20 of radiation therapy and mitomycin IV on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity. Patients also undergo a TURBT with bladder biopsy at randomization and week 18 as well as cystoscopy at randomization, at weeks 18, 30, 42, 54, then every 3 months through year 2, followed by every 6months through year 5 and CT or MRI at randomization, at weeks 18, 30, 42, 54, then every 6 months through year 2, followed by every 12 months through year 5.
• Experimental: Arm II (RT, chemotherapy, atezolizumab)
  Patients undergo RT (3DCRT or IMRT) daily Monday-Friday for up to 7-8 weeks and receive chemotherapy based on physician's choice as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo a TURBT with bladder biopsy at randomization and week 18 as well as cystoscopy at randomization, at weeks 18, 30, 42, 54, then every 3 months through year 2, followed by every 6months through year 5 and CT or MRI at randomization, at weeks 18, 30, 42, 54, then every 6 months through year 2, followed by every 12 months through year 5.

Primary Outcome Measure

Bladder intact event-free survival (BI-EFS) [ Time Frame: From the date of randomization to the first documentation of a BI-EFS event, assessed up to 5 years ]

Locations (366)

Find similar trials in Phoenix, AZ

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