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Multidisciplinary Bladder-preservation Therapy for Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
multidisciplinary bladder-preservation therapy
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring multidisciplinary; bladder cancer; bladder-preservation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multidisciplinary Therapy

Arm Description

Multidisciplinary bladder-preservation therapy: Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy

Outcomes

Primary Outcome Measures

Complete response rate
Response to MBPT depending on cystoscopy, TURBt, or urinary cytology
Disease specific survival (DSS) time
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.
Overall survival (OS) time
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.

Secondary Outcome Measures

Quality of life score 1
Assessed by EORTC Quality of life questionaire (QLQ)-30
Quality of life score 2
Assessed by EORTC QLQ-Bladder Cancer 30

Full Information

First Posted
November 15, 2018
Last Updated
November 26, 2018
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03756207
Brief Title
Multidisciplinary Bladder-preservation Therapy for Bladder Cancer
Official Title
Clinical Study on Efficacy and Safety of Multidisciplinary Bladder-preservation Therapy for Muscle-invasive Bladder Cancer in China
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
multidisciplinary; bladder cancer; bladder-preservation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
In this study, the investigators plan to prospectively recruit 80 muscle-invasive bladder cancer patients, who don't want to receive radical cystectomy or are not candidates for radical cystectomy, treated with multidisciplinary bladder-preservation therapy from Nov 2018 to Dec 2020 in Peking University Third Hospital.
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multidisciplinary Therapy
Arm Type
Experimental
Arm Description
Multidisciplinary bladder-preservation therapy: Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy
Intervention Type
Procedure
Intervention Name(s)
multidisciplinary bladder-preservation therapy
Intervention Description
Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy
Primary Outcome Measure Information:
Title
Complete response rate
Description
Response to MBPT depending on cystoscopy, TURBt, or urinary cytology
Time Frame
6-8 weeks after chemoradiation
Title
Disease specific survival (DSS) time
Description
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.
Time Frame
From date of treatment initiation until the date of death due to bladder cancer, assessed up to 60 months.
Title
Overall survival (OS) time
Description
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.
Time Frame
From date of treatment initiation until the date of death due to any cause, assessed up to 60 months.
Secondary Outcome Measure Information:
Title
Quality of life score 1
Description
Assessed by EORTC Quality of life questionaire (QLQ)-30
Time Frame
6-8 weeks after chemoradiation
Title
Quality of life score 2
Description
Assessed by EORTC QLQ-Bladder Cancer 30
Time Frame
6-8 weeks after chemoradiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bladder urothelial carcinoma Clinical stage: T2-T4, non-metastasis Eastern Cooperative Oncology Group score (ECOG)≤ 1, Karnofsky performance score≥ 70 Patients don't want to receive RC or are not candidates for RC Normal bladder function Exclusion Criteria: History of abdominal and pelvic radiotherapy History of other malignant tumor Pregnant or lactating patients Severe comorbidity: cardiac infarction, arrhythmia, heart failure, et al
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hai Bi, MD
Phone
+86-13488714943
Email
pku-bihai@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Huang, MD
Organizational Affiliation
Department of Urology, Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hai Bi, MD
Phone
+86-13488714943
Email
pku-bihai@163.com

12. IPD Sharing Statement

Learn more about this trial

Multidisciplinary Bladder-preservation Therapy for Bladder Cancer

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