A Phase II Study of Dose Dense Gemcitabine Plus Cisplatin in Patients with Muscle Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deletrious DNA Damage Response Gene Alterations

April 7, 2020

Clinical Trial Information

PROTOCOL: Alliance-A031701

SCHEMA A031701

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.


  1. Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or EUA. The diagnostic TURBT sample must have been obtained within 60 days prior to registration.
  2. Clinical stage T2-T4aN0/xM0 disease.
  3. Medically appropriate candidate for radical cystectomy as assessed by surgeon.
  4. No concomitant multifocal carcinoma in situ; a single focus is allowed.
  5. One focus of muscle-invasive bladder cancer and/or a tumor <5 cm in size.
  6. No clinical or radiographic evidence for locally advanced or metastatic disease.
  7. No prior anti-PD-1, anti PD-L1 therapies, or systemic chemotherapy (prior intravesical induction immunotherapy for non-muscle invasive disease is allowed, defined as BCG x6 treatments; BCG refractory disease, defined as disease recurrence within 3 months of BCG therapy, is not allowed).
  8. No prior radiation therapy to the bladder.
  9. No major surgery or radiation therapy <4 weeks of registration.
  10. Age ≥ 18 years.
  11. ECOG Performance Status 0-1.

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