Multidisciplinary Bladder-preservation Therapy for Bladder Cancer

November 26, 2018 updated by: Peking University Third Hospital

Clinical Study on Efficacy and Safety of Multidisciplinary Bladder-preservation Therapy for Muscle-invasive Bladder Cancer in China

A multidisciplinary approach has led to the development of bladder-preservation therapy using maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy for muscle-invasive bladder cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Multidisciplinary management improves complex treatment decision making in cancer care, but its impact for bladder cancer has not been documented. Although radical cystectomy (RC) has long been the standard of care for the management of muscle-invasive bladder cancer (MIBC), a multidisciplinary approach has led to the development of bladder-preservation therapy using maximal transurethral resection (TURBt) followed by radiotherapy with concomitant radio-sensitizing chemotherapy for MIBC. There are no randomized-controlled data comparing radical cystectomy with multidisciplinary bladder-preservation therapy (MBPT) available for comparison. However, observational data continues to support the use of MBPT as an acceptable alternative for patients with MIBC who wish to preserve their bladder or are not candidates for cystectomy because it may result in equivalent disease outcomes in select patients and offers the benefit of maintaining a functioning urinary system with subsequent improvements in quality of life. But there are also lots of issues need to be studied, such as the patient selection, approaches for completeness of TURBt, choices of radio-sensitizing chemotherapy, accuracy of radiotherapy and so on. In this study, the investigators plan to prospectively recruit 80 MIBC patients, who don't want to receive RC or are not candidates for RC, treated with MBPT from Nov 2018 to Dec 2020 in Peking University Third Hospital. The investigators will collect, compare and analyze their clinic-pathological data before and after MBPT, in order to confirm the safety and efficacy of MBPT for MIBC in China. At the same time, the investigators want to find out the patients who are not suitable for MBPT and the approach which can improve the efficacy of MBPT, as a result, the investigators intend to make a standard MBPT approach for Chinese MIBC patients.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Bladder urothelial carcinoma
  2. Clinical stage: T2-T4, non-metastasis
  3. Eastern Cooperative Oncology Group score (ECOG)≤ 1, Karnofsky performance score≥ 70
  4. Patients don't want to receive RC or are not candidates for RC
  5. Normal bladder function

Exclusion Criteria:

  1. History of abdominal and pelvic radiotherapy
  2. History of other malignant tumor
  3. Pregnant or lactating patients
  4. Severe comorbidity: cardiac infarction, arrhythmia, heart failure, et al

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multidisciplinary Therapy
Multidisciplinary bladder-preservation therapy: Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy
Procedure: multidisciplinary bladder-preservation therapy
Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate
Time Frame: 6-8 weeks after chemoradiation
Response to MBPT depending on cystoscopy, TURBt, or urinary cytology
6-8 weeks after chemoradiation
Disease specific survival (DSS) time
Time Frame: From date of treatment initiation until the date of death due to bladder cancer, assessed up to 60 months.
Events were defined as death attributable to bladder cancer. The time to DSS was the interval between treatment initiation and death due to bladder cancer, or the most recent follow-up if no event occurred.
From date of treatment initiation until the date of death due to bladder cancer, assessed up to 60 months.
Overall survival (OS) time
Time Frame: From date of treatment initiation until the date of death due to any cause, assessed up to 60 months.
Events were defined as death due to any cause. The time to OS was the interval between treatment initiation and death, or the most recent follow-up if no event occurred.
From date of treatment initiation until the date of death due to any cause, assessed up to 60 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score 1
Time Frame: 6-8 weeks after chemoradiation
Assessed by EORTC Quality of life questionaire (QLQ)-30
6-8 weeks after chemoradiation
Quality of life score 2
Time Frame: 6-8 weeks after chemoradiation
Assessed by EORTC QLQ-Bladder Cancer 30
6-8 weeks after chemoradiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Yi Huang, MD, Department of Urology, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

November 15, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2018183

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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