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Radiation Therapy + Chemotherapy for Bladder Cancer

Phase 1

Waitlist Available

Led By Marisa Kollmeier, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

MSKCC-reviewed pathologically proven diagnosis of primary bladder urothelial carcinoma without evidence of regional (nodal) or distant spread (cT1-T4a, Nx or N0)

Patients must be considered able to tolerate systemic chemotherapy and pelvic radiation therapy

Must not have

Active inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)

Women who are pregnant or lactating

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if different doses of radiation therapy, combined with chemotherapy, is safe for cancer patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include skin irritation from radiation, fatigue, nausea from chemotherapy, low blood cell counts increasing infection risk and bleeding potential. Kidney function may also be affected by the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am deemed fit for chemotherapy and radiation therapy in the pelvic area.

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My kidneys are working well enough, based on a specific test.

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My bladder works well and I don't need a catheter.

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I am able to care for myself but may not be able to do active work.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active inflammatory bowel condition.

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I am not pregnant or breastfeeding.

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I have had more than 4 cycles of chemotherapy with cisplatin before surgery.

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I have had radiation therapy in the pelvic area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiotherapy and Concurrent Gemcitabine ChemotherapyExperimental Treatment1 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.

0 / 10Eligibility criteria met