Study on Risk-Adapted Treatment After Starting Chemotherapy for Bladder Cancer (RETAIN)

Sponsor: Fox Chase Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02710734

Provider View

This clinical trial is exploring a personalized treatment approach for muscle-invasive bladder cancer. By analyzing tumor samples and using chemotherapy, the study aims to determine the best treatment plan, which may include active monitoring, standard therapies, or surgery, to improve survival and maintain quality of life.

Patient Parameters

Program Overview

The purpose of this study is to test a personalized treatment strategy for bladder cancer that has spread to the muscle. Initially, a sample of the bladder tumor is taken and analyzed while patients receive a specific chemotherapy regimen called AMVAC. Based on the genetic profile of the tumor and the results after chemotherapy, patients will either be closely monitored, receive standard treatments like intravesical therapy, chemoradiation, or undergo surgery. The goal is to achieve similar survival rates at 2 years while preserving the bladder and improving quality of life for some patients.

Description

This phase II study is investigating how well a combination of surgery and chemotherapy, followed by radiation therapy, works in treating bladder cancer that has invaded the muscle. The chemotherapy drugs used—methotrexate, vinblastine, doxorubicin, and cisplatin—work by stopping cancer cells from growing, dividing, or spreading. Radiation therapy uses high-energy x-rays to kill cancer cells and shrink tumors. By combining chemotherapy with radiation before surgery, the treatment may reduce the size of the tumor and the amount of healthy tissue that needs to be removed.

Eligibility Criteria

Inclusion Criteria

  • Male or female patients aged 18 years or older.
  • Diagnosed with primary or mostly urothelial carcinoma of the bladder.
  • Evidence of cancer invading the muscle layer of the bladder.
  • Clinical stage T2-T4a according to AJCC27.
  • No signs of cancer spread to lymph nodes or other parts of the body.
  • ECOG performance status of 0, 1, or 2, indicating good overall health.
  • Heart function with an ejection fraction of 50% or higher.
  • Normal organ and bone marrow function, including:
    • White blood cell count of at least 3,000/mcL
    • Neutrophil count of at least 1,500/mcL
    • Platelet count of at least 100,000/mcL
    • Normal bilirubin and liver enzyme levels
    • Kidney function with creatinine clearance of at least 50 mL/min

Exclusion Criteria

  • Presence of small cell cancer features.
  • Previous radiation therapy to the pelvis or significant bone marrow radiation in the past year.
  • Previous chemotherapy for bladder cancer or other cancers within the past year.
  • Other cancers within the past 5 years, except for certain skin cancers.
  • Recent use of experimental treatments within 4 weeks.
  • Allergies to similar chemotherapy drugs used in the study.
  • Uncontrolled health issues like infections, heart problems, or psychiatric conditions.
  • Pregnant women due to risks to the unborn baby.
  • HIV-positive patients on antiretroviral therapy due to potential drug interactions and infection risks.
  • Untreated kidney swelling (hydronephrosis).
  • Women who are pregnant or could become pregnant.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.