Multidisciplinary Bladder-preservation Therapy for Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03756207
• Other study ID #: M2018183
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2018
• Source: Peking University Third Hospital
• Contact: Hai Bi, MD
• Phone: +86-13488714943
• Email: pku-bihai[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate	Response to MBPT depending on cystoscopy, TURBt, or urinary cytology	6-8 weeks after chemoradiation
Primary	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.	From date of treatment initiation until the date of death due to bladder cancer, assessed up to 60 months.
Primary	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.	From date of treatment initiation until the date of death due to any cause, assessed up to 60 months.
Secondary	Quality of life score 1	Assessed by EORTC Quality of life questionaire (QLQ)-30	6-8 weeks after chemoradiation
Secondary	Quality of life score 2	Assessed by EORTC QLQ-Bladder Cancer 30	6-8 weeks after chemoradiation