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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

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

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

Primary outcome measures

Metastasis-free survival (MFS) at 2 years.

Secondary outcome measures

Ability to complete of 3 cycles of neoadjuvant AMVAC and chemoradiation therapy with 5-FU and mitomycin C.

Other outcome measures

Endoscopic Tumor Quantification System score at each TURBT

Overall survival and PFS of the entire cohort

Proportion of patients requiring a cystectomy, either immediately after TURBT#2 or as salvage after surveillance or CRT

+4 more

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

Intensity modulated radiation therapy (IMRT)

2019

Completed Phase 2

~80

Doxorubicin

2012

Completed Phase 3

~7940

Mitomycin C

2019

Completed Phase 4

~820

Methotrexate

2013

Completed Phase 4

~3800

Cisplatin

2013

Completed Phase 3

~1940

Vinblastine

1998

Completed Phase 3

~5260

5-FU

2014

Completed Phase 3

~3420

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor

227 Previous Clinical Trials

37,431 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

Frequently Asked Questions

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

Are there remaining vacancies for participants of this research project?

"This trial is now closed to new participants, having been first posted on February 24th 2016 and last updated December 1st 2021. If you are looking for an alternate study, there are presently 315 studies actively enrolling patients with urinary bladder issues and 1202 trials concerning Transurethral Resection of Bladder tumours accepting candidates."

Answered by AI

What conditions is Transurethral Resection of Bladder tumor commonly prescribed to alleviate?

"Transurethral Resection of Bladder tumor is frequently employed to treat advanced testicular cancer and other maladies such as multiple sclerosis, advance directives, glaucoma."

Answered by AI

Could you provide details about prior research into Transurethral Resection of Bladder tumor?

"The current number of active clinical trials exploring Transurethral Resection of Bladder tumor is 1202 with 427 Phase 3 studies. Shanghai is the most common location for these experiments, but there are 69717 other sites across the globe running related research."

Answered by AI

Is this study pioneering a new approach to treatment?

"There are currently 1202 active Transurethral Resection of Bladder tumor trials taking place in 3613 cities across 81 nations. Alfacell's 1997 Phase 3 clinical trial, which featured 300 participants, was the first to explore this treatment and since then 2154 experiments have been conducted."

Answered by AI

What is the participant enrollment capacity of this clinical research?

"This research project is now closed as of December 1st 2021. Initially, it was posted on February 24th 2016 and the latest update occurred in late 2021. If you are looking for alternative studies, there are presently 315 trials admitting patients with urinary bladder issues and 1202 investigations actively recruiting participants to investigate Transurethral Resection of Bladder tumor treatments."

Answered by AI

What adverse health effects can be incurred from Transurethral Resection of Bladder tumor?

"Although the efficacy of Transurethral Resection of Bladder tumor has yet to be established, there is evidence suggesting it's safety profile. As a result, our team at Power have rated its safety as 2 on a scale from 1-3."

Answered by AI

Recent research and studies

Current Oncology ReportsJournal

Lack of Evidence Does Not Equal Lack of Benefit: Neoadjuvant Chemotherapy and Trimodality Therapy in Selected Patients with Muscle-invasive Bladder Cancer

Jiang, Di Maria, Peter Chung, Girish S. Kulkarni, Nick D. James, and Srikala S. Sridhar. 2021. “Lack of Evidence Does Not Equal Lack of Benefit: Neoadjuvant Chemotherapy and Trimodality Therapy in Selected Patients with Muscle-invasive Bladder Cancer”. Current Oncology Reports. Springer Science and Business Media LLC. doi:10.1007/s11912-021-01035-9.

clinicaltrials.govStudy

Risk Enabled Therapy After Initiating Neoadjuvant Chemotherapy for Bladder Cancer (RETAIN)

2016. "Risk Enabled Therapy After Initiating Neoadjuvant Chemotherapy for Bladder Cancer (RETAIN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02710734.

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