Multidisciplinary Bladder-preservation Therapy for Bladder Cancer

Peking University

Status: Unknown

Conditions: Bladder Cancer

Treatments: Procedure: multidisciplinary bladder-preservation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03756207

M2018183

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Multidisciplinary Therapy

Experimental group

Description:

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

Treatment:

Procedure: multidisciplinary bladder-preservation therapy