Multidisciplinary Bladder-preservation Therapy for Bladder Cancer

NCT03756207 | Unknown DMC

• 1 other identifier: M2018183
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

multidisciplinary; bladder cancer; bladder-preservation

Outcome Measures

Primary Outcomes (3)

• Complete response rate

  Response to MBPT depending on cystoscopy, TURBt, or urinary cytology

  6-8 weeks after chemoradiation

• 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.

• 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 Outcomes (2)

• Quality of life score 1

  6-8 weeks after chemoradiation

• Quality of life score 2

  6-8 weeks after chemoradiation

Study Arms (1)

Multidisciplinary Therapy

EXPERIMENTAL

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

Procedure: multidisciplinary bladder-preservation therapy

Interventions

multidisciplinary bladder-preservation therapy PROCEDURE

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

Multidisciplinary Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of abdominal and pelvic radiotherapy
• History of other malignant tumor
• Pregnant or lactating patients
• Severe comorbidity: cardiac infarction, arrhythmia, heart failure, et al

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Yi Huang, MD

  Department of Urology, Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hai Bi, MD

CONTACT

+86-13488714943; pku-bihai@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 28, 2018
• Study Start: November 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: November 28, 2018

Record last verified: 2018-11

Locations

CN (1)