Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer (Study SWOG/NRG 1806)

Purpose

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. Drugs used in chemotherapy, 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.

Eligibility

  • Ages: 18 and older
  • Sexes: All
  • Accepts healthy volunteers?: No
For additional eligibility criteria, please contact the study team.

Procedures

Active Comparator: Arm I (RT, chemotherapy)

Patients undergo RT (3D CRT or IMRT) Monday-Friday for up to 7 weeks. Patients also receive chemotherapy based on physician's choice of gemcitabine IV twice weekly for 6 weeks, 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.

Experimental: Arm II (RT, chemotherapy, atezolizumab)
Patients undergo RT (3DCRT or IMRT) Monday-Friday for up to 7 weeks and receive chemotherapy based on physician's choice as in Arm I. Patients also receive atezolizumab IV over 60 minutes on day 1 of chemotherapy. Treatment repeats every 21 days for a total of 6 months (9 doses total) in the absence of disease progression or unacceptable toxicity.

Contact the study team

Additional eligibility criteria and study procedure details can be explained by the study team. Please call or email:

Diane Richardson
Phone: 352.265.0702
Email: drichardson@ufl.edu

Age

18 to 65
65 and over

Gender

Male
Female

Keywords

Chemoradiotherapy, Bladder cancer, Radiation therapy

Principal Investigator

Paul Crispen, MD

Department

Oncology

Contact Information

drichardson@ufl.edu

352.265.0702


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