Multidisciplinary Bladder-preservation Therapy for Bladder Cancer

NCT ID: NCT03756207

Last Updated: 2018-11-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2021-12-31

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multidisciplinary Therapy

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

Group Type: EXPERIMENTAL

multidisciplinary bladder-preservation therapy

Intervention Type: PROCEDURE

Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy

Interventions

multidisciplinary bladder-preservation therapy

Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hai Bi, MD

Role: CONTACT

pku-bihai@163.com

+86-13488714943

Facility Contacts

Hai Bi, MD

Role: primary

pku-bihai@163.com

+86-13488714943

Other Identifiers

M2018183

Identifier Type: -

Identifier Source: org_study_id