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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine the dose limiting toxicity and establish the maximal tolerated dose

Secondary outcome measures

To determine the complete response rate of the primary tumor

To determine the long term toxicity

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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,603 Total Patients Enrolled

Marisa Kollmeier, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

45 Total Patients Enrolled

Media Library

External Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT01104350 — Phase 1

Bladder Cancer Research Study Groups: Radiotherapy and Concurrent Gemcitabine Chemotherapy

Bladder Cancer Clinical Trial 2023: External Radiation Therapy Highlights & Side Effects. Trial Name: NCT01104350 — Phase 1

External Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01104350 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the combination of external radiation therapy and gemcitabine sanctioned by the FDA?

"With limited evidence of efficacy and safety, external radiation therapy combined with gemcitabine scored a 1 on our team's risk assessment scale."

Answered by AI

How many health care facilities are currently conducting this clinical trial?

"At the moment, this investigation is being conducted in 5 locations across Basking Ridge, Rockville Centre and Harrison as well as two other cities. Therefore, to minimise travelling expenses it's a good idea to select a clinic near you."

Answered by AI

Does this research endeavor still have vacancies for volunteers?

"The information available on clinicaltrials.gov confirms that this medical research is no longer recruiting participants, despite being initially posted in April 2010 and last updated March 2022. However, there are presently 373 other trials seeking volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy

2010. "Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01104350.

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