Radiation Therapy + Chemotherapy for Bladder Cancer

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Distant disease, Nodal metastases, Inflammatory bowel, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

19 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to test the safety of different amounts (doses) of external radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with chemotherapy.

Who Is on the Research Team?

Marisa A. Kollmeier

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with bladder cancer that hasn't spread beyond the region. They must have a good performance status, normal blood counts and liver function, adequate kidney function, and be able to sign consent. Pregnant women or those with prior pelvic radiation, certain chemotherapy treatments, or inflammatory bowel disease cannot participate.

Inclusion Criteria

My bladder cancer is confirmed and has not spread beyond the bladder.

Patients must have the ability to understand and the willingness to sign a written informed consent document

You need to have at least 100,000 platelets per cubic millimeter of blood.

Exclusion Criteria

My cancer has spread to distant areas or lymph nodes, confirmed by tests.

I've had chemotherapy for bladder cancer that didn't include cisplatin.

I have an active inflammatory bowel condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation and Chemotherapy

Participants receive intensity modulated external radiation therapy using image-guidance in combination with gemcitabine chemotherapy

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• External Radiation Therapy
• Gemcitabine

Trial Overview The study tests different doses of external radiation therapy alongside gemcitabine chemotherapy to see how safe they are when combined. The goal is to find out if these treatments can effectively shrink or destroy bladder cancer without causing too much harm.

How Is the Trial Designed?

Group I: Radiotherapy and Concurrent Gemcitabine Chemotherapy Experimental Treatment 1 Intervention

This is a Phase I dose-escalation study examining the safety and tolerability of intensity modulated external radiation therapy using image-guidance in combination with gemcitabine chemotherapy as an alternative to radical cystectomy.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+