Bladder CancerNCT03756207
Multidisciplinary Bladder-preservation Therapy for Bladder Cancer
A study testing multidisciplinary bladder-preservation therapy in people with Bladder Cancer, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- multidisciplinary bladder-preservation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of abdominal and pelvic radiotherapy
- History of other malignant tumor
- Pregnant or lactating patients
- Severe comorbidity: cardiac infarction, arrhythmia, heart failure, et al
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Hai Bi, MD, +86-13488714943, pku-bihai@163.com
About this study
Official title: Clinical Study on Efficacy and Safety of Multidisciplinary Bladder-preservation Therapy for Muscle-invasive Bladder Cancer in China
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.
Read the 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
- Being tested
- multidisciplinary bladder-preservation therapy
- Keywords
- multidisciplinary; bladder cancer; bladder-preservation
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary bladder-preservation therapyProcedure or surgery
Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary Therapy | Experimental | Multidisciplinary bladder-preservation therapy: Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy Receives: Procedure: multidisciplinary bladder-preservation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Response to MBPT depending on cystoscopy, TURBt, or urinary cytology
Measured: 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.
Measured: 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.
Measured: 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
Assessed by EORTC Quality of life questionaire (QLQ)-30
Measured: 6-8 weeks after chemoradiation
Quality of life score 2
Assessed by EORTC QLQ-Bladder Cancer 30
Measured: 6-8 weeks after chemoradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Nov 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Huang, MD, Principal investigator, Department of Urology, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756207
- Sponsor's protocol ID
- M2018183
- Status last verified
- Nov 2018
- First submitted
- 15 Nov 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Efficacy and Safety of Multidisciplinary Bladder-preservation Therapy for Muscle-invasive Bladder Cancer in China
- ClinicalTrials.gov ID
- NCT03756207
- Acronym / sponsor ID
- M2018183
- Conditions
- Bladder Cancer
- Keywords
- multidisciplinary; bladder cancer; bladder-preservation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary Therapy | Experimental | Procedure: multidisciplinary bladder-preservation therapyMultidisciplinary bladder-preservation therapy: Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- History of abdominal and pelvic radiotherapy
- History of other malignant tumor
- Pregnant or lactating patients
- Severe comorbidity: cardiac infarction, arrhythmia, heart failure, et al
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multidisciplinary bladder-preservation therapyMaximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy | Procedure or surgery | Multidisciplinary Therapy |
Primary outcome
Complete response rate
Time frame: 6-8 weeks after chemoradiation
Response to MBPT depending on cystoscopy, TURBt, or urinary cytology
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.
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.
2 secondary outcomes
Quality of life score 1
Time frame: 6-8 weeks after chemoradiation
Quality of life score 2
Time frame: 6-8 weeks after chemoradiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Huang, MD principal investigator
Department of Urology, Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multidisciplinary bladder-preservation therapy in people with Bladder Cancer, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hai Bi, MD (+86-13488714943, pku-bihai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: 6-8 weeks after chemoradiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.