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Anti-tumor antibiotic

Chemotherapy + Radiation for Bladder Cancer

Phase 2
Waitlist Available
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
AJCC27 clinical stage T2-T4a
Primary urothelial or predominantly urothelial carcinoma of the bladder
Must not have
Prior systemic chemotherapy; patients who have received any previous systemic chemotherapy or radiation therapy for urothelial carcinoma or cytotoxic chemotherapy for another malignancy within 1 year of study entry are ineligible
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Methotrexate, Vinblastine, Adriamycin or Cisplatin or other agents used in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to treat bladder cancer that could be less invasive and have a better quality of life for patients.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Possible side effects include those common to chemotherapy such as nausea, fatigue, hair loss; Methotrexate might cause mouth sores; Cisplatin can lead to kidney damage and hearing issues; Radiation therapy may result in skin irritation and bowel problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is at a stage where it has grown but not spread to distant parts.
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My cancer is mainly in the bladder and is of urothelial type.
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My scans show no signs of cancer in my lymph nodes or elsewhere in my body.
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I can take care of myself and perform daily activities.
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My blood tests show normal organ and bone marrow function.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had chemotherapy or radiation for bladder cancer or any cancer treatment in the last year.
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I am allergic to certain chemotherapy drugs or similar medications.
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I have swelling of a kidney due to urine buildup that hasn't been treated.
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My cancer has small cell components.
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I have not had radiation therapy to my pelvis or to a large part of my bone marrow in the last year.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I am not pregnant, as the treatment could harm an unborn baby.
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I am HIV-positive and not on antiretroviral therapy.
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I am not pregnant and am taking birth control if I can have children.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Endoscopic Tumor Quantification System score at each TURBT
Quality of life with neoadjuvant AMVAC and subsequent risk-adapted treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3120
Methotrexate
2019
Completed Phase 4
~4400
Mitomycin C
2019
Completed Phase 4
~840
Vinblastine
1998
Completed Phase 3
~5410
5-FU
2014
Completed Phase 3
~3100
Doxorubicin
2012
Completed Phase 3
~8030
Intensity modulated radiation therapy (IMRT)
2019
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
234 Previous Clinical Trials
39,295 Total Patients Enrolled

Media Library

Doxorubicin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT02710734 — Phase 2
Bladder Cancer Research Study Groups: Intravesicle therapy, Surveillance, Radical Cystectomy, CRT
Bladder Cancer Clinical Trial 2023: Doxorubicin Highlights & Side Effects. Trial Name: NCT02710734 — Phase 2
Doxorubicin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02710734 — Phase 2
~15 spots leftby Feb 2027
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