Chemotherapy + Radiation for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Fox Chase Cancer Center

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The aim of this study is to evaluate a risk-adapted approach to the treatment of muscle invasive bladder cancer. Each baseline transuretheral resection of bladder tumor (TURBT) sample will be sequenced while proceeding with neoadjuvant accelerated methotrexate, vinblastine, doxorubicin, and cisplatin (AMVAC) chemotherapy. Based on the mutational profile and the post AMVAC TURBT findings, patients will be treated with active surveillance (experimental arm), or standard of care intravesicle therapy, chemoradiation or surgery. We hypothesize that this approach will lead to non-inferior metastasis-free survival at 2 years, while preserving the bladder and thus quality-of-life for a proportion of patients.

Research Team

Eligibility Criteria

This trial is for adults with muscle-invasive bladder cancer, without lymph node or distant metastases, and a good performance status. They must have urothelial carcinoma and normal heart function plus adequate organ and bone marrow function. Exclusions include prior pelvic radiation, recent experimental drugs, uncontrolled illnesses, pregnancy, other cancers within 5 years (except non-melanoma skin), previous chemo for urothelial carcinoma within a year or any chemo within a year.

Inclusion Criteria

There is evidence that the cancer has spread into the muscle layer of the organ.

My cancer is at a stage where it has grown but not spread to distant parts.

My cancer is mainly in the bladder and is of urothelial type.

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Exclusion Criteria

I have no other cancers except for non-melanoma skin cancer or have been cancer-free for 5 years.

I haven't had chemotherapy or radiation for bladder cancer or any cancer treatment in the last year.

I am allergic to certain chemotherapy drugs or similar medications.

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Treatment Details

Interventions

Doxorubicin (Anti-tumor antibiotic)
Methotrexate (Anti-metabolites)
Transurethral Resection of Bladder tumor (Procedure)
Vinblastine (Vinca alkaloids)

Trial OverviewThe RETAIN study tests whether personalized treatment based on genetic sequencing of tumor samples can maintain survival rates while preserving the bladder after neoadjuvant AMVAC chemotherapy. Patients may undergo active surveillance or standard treatments like intravesical therapy, chemoradiation or surgery depending on their response to initial treatment.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: SurveillanceExperimental Treatment5 Interventions

Trimodality of Maximal TURBT#1 Followed by AMVAC and TURBT#2 and then active surveillance

Group II: Radical CystectomyExperimental Treatment5 Interventions

Trimodality of Maximal TURBT#1 Followed by AMVAC and TURBT#2 and then cystectomy

Group III: Intravesicle therapyExperimental Treatment5 Interventions

Trimodality of Maximal TURBT#1 Followed by AMVAC and TURBT#2 and then intravesicle therapy followed by TURBT#3

Group IV: CRTExperimental Treatment8 Interventions

Trimodality of Maximal TURBT#1 Followed by AMVAC and TURBT#2 and then chemoradiation followed by TURBT#3

Doxorubicin is already approved in Canada, Japan for the following indications: