Radiation Therapy + Chemotherapy for Bladder Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of combining external radiation therapy with chemotherapy using Gemcitabine (Gemzar) for bladder cancer treatment. The goal is to determine the optimal radiation dose that can be safely used with chemotherapy to shrink or destroy cancer cells. Candidates include individuals with bladder cancer that has not metastasized and who can tolerate the treatment. This study aims to offer an alternative to surgery for bladder cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, allowing participants to contribute to groundbreaking research.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that external radiation therapy can be safely increased to higher doses when targeted at bladder tumors. This allows stronger radiation to combat cancer without causing additional harm. However, radiation may increase the risk of developing another bladder cancer later.

Gemcitabine, a chemotherapy drug, is generally safe and well-tolerated. Some studies have demonstrated its effectiveness when used inside the bladder to prevent cancer recurrence. The FDA has approved gemcitabine for certain bladder cancer treatments, indicating a strong safety record.

Both treatments have demonstrated safety, but this trial tests them together in a new way to evaluate their effectiveness and potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bladder cancer?

Researchers are excited about this treatment for bladder cancer because it combines intensity-modulated external radiation therapy with Gemcitabine chemotherapy, potentially offering a less invasive alternative to radical cystectomy. Unlike traditional treatments that often require bladder removal, this approach aims to preserve the bladder while targeting cancer cells with precision. By using image-guided radiation, it delivers higher doses directly to the tumor with minimal damage to surrounding tissues, enhancing safety and tolerability. This innovative combination may improve quality of life for patients by reducing the need for surgical interventions.

What evidence suggests that radiation therapy and chemotherapy could be effective for bladder cancer?

In this trial, participants will receive a combination of external radiation therapy and the chemotherapy drug gemcitabine. Research has shown that this combination may be promising for treating bladder cancer. One study found a 5-year overall survival rate of 59%, indicating that just over half of the patients were alive five years after treatment. Additionally, about 93.3% of patients did not require bladder removal surgery after five years. Another trial indicated that this treatment is generally well-tolerated, even in older patients. These findings suggest that using radiation and gemcitabine together could be an effective option for bladder cancer, offering a chance to preserve the bladder while managing the disease. ^{6 7 8 9 10}

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814016343043#!

Meta analysis Concurrent gemcitabine and radiotherapy ... The 5-year overall survival (OS), disease-specific survival (DSS), and cystectomy-free survival (CFS) rates were 59%, 80.9%, and 93.3%, respectively. The ...

2. ascopubs.org ascopubs.org/doi/10.1200/jco.2016.34.2_suppl.443

External beam radiotherapy and concurrent gemcitabine ... Conclusions: EBRT with concurrent gemcitabine is well-tolerated for MIBC, even in an elderly population. Hematologic (acute) and genitourinary ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11853320/

The Promise of Radiotherapy in High-Risk Non-Muscle ... This trial, which included muscle-invasive and high-grade NMIBC participants, demonstrated a 10-year overall survival of 30% (95% CI 0.23–0.39) ...

4. redjournal.org redjournal.org/article/S0360-3016(24)01923-0/fulltext

Hypofractionated Intensity Modulated Radiation Therapy ... 5-year OS, LRFS, DMFS, cystectomy-free survival and intact bladder survival rates were 59.2%, 77.6%, 77.4%, 87.4% and 56.5%, respectively. On ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)35099-9/fulltext

Combined chemoradiotherapy with gemcitabine in patients ... The 2-year locoregional failure rate was 32% (9/28); 10 of 28 patients (38%) were alive with an intact bladder and no evidence of recurrent disease, 9 patients ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405456924002621

Incidence and Outcomes of Secondary Bladder Cancer ... This study demonstrates that both external beam radiation therapy and brachytherapy increase the risk of secondary bladder cancer (SBC).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11240771/

Incidence, Characteristics and Survival Rates of Bladder ... In the cumulative incidence plots, ten-year bladder cancer-specific mortality rates of 10.6% in EBRT-exposed patients vs. 12.6% in EBRT- ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11897634/

Radiotherapy can significantly improve survival outcomes ... Radiotherapy can significantly improve survival outcomes in patients with muscle-invasive bladder cancer who are unsuitable for cystectomy or chemoradiotherapy ...

9. ar.iiarjournals.org ar.iiarjournals.org/content/36/10/5519

Clinical Results for Bladder Cancer Treated by ... Results: Median survival was 10 months (range=1-99); 1-year and 3-year survival was 51.4% and 34.3%, respectively. Radiation dose >50 Gy was associated with ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0360301624031377

Clinical Outcomes of a Phase I Dose Escalation Study Bladder tumor-focused radiation therapy delivered with an adaptive technique enables safe dose escalation above the conventional standard dose of 64 Gy in 32 ...