Multidisciplinary Bladder-preservation Therapy for Bladder Cancer

• ClinicalTrials.gov Identifier: NCT03756207
• Recruitment Status: Unknown
• First Posted: November 28, 2018
• Last Update Posted: November 28, 2018
• Sponsor: Peking University Third Hospital
• Information provided by (Responsible Party): Peking University Third Hospital

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.

Condition or disease	Intervention/treatment	Phase
Bladder Cancer	Procedure: multidisciplinary bladder-preservation therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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)
• Primary Purpose: Treatment
• Official Title: Clinical Study on Efficacy and Safety of Multidisciplinary Bladder-preservation Therapy for Muscle-invasive Bladder Cancer in China
• Actual Study Start Date: November 1, 2018
• Estimated Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Complete response rate [ Time Frame: 6-8 weeks after chemoradiation ]
   Response to MBPT depending on cystoscopy, TURBt, or urinary cytology
2. 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.
3. 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.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Hai Bi, MD; +86-13488714943; pku-bihai@163.com

Locations

China, Beijing

Peking University Third Hospital; Recruiting

Beijing, Beijing, China, 100191

Contact: Hai Bi, MD +86-13488714943 pku-bihai@163.com

Sponsors and Collaborators

Peking University Third Hospital

Investigators

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

More Information

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT03756207
• Other Study ID Numbers: M2018183
• First Posted: November 28, 2018
• Last Update Posted: November 28, 2018
• Last Verified: November 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peking University Third Hospital:

multidisciplinary; bladder cancer; bladder-preservation

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases