Muscle-Invasive Bladder CarcinomaNCT04686149
a Genome-based Platform to Predict Patients That Can Achieve Bladder Preservation in Muscle Invasive Bladder Cancer Patients
An observational study of Muscle-Invasive Bladder Carcinoma, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is aimed to develop a genome-based platform to predict patients who can achieve bladder preservation after neoadjuvant treatment. The main treatments for invasive bladder cancer are radical cystectomy and intrapelvic lymph node dissection, but 50% of patients experience recurrence within 2 years after… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2021to Dec 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with muscle invasive bladder cancer are subject to this trial. For bladder preservation, the patients receive neoadjvuvant CCRT. In case that clinical CR status obtained after CCRT in patients initally T2N0M0, no additional treatment is performed. Patients without clinical CR status are treated with neoadjuvant chemotherapy. After chemotherapy, the response is evaluated. If residual tumor is found, the radical cystectomy is performed.
Who may be able to join
- Patients older than 19 years old
- Clinically or histologically diagnosed urothelial carcinoma bladder cancer
- Patients who satisfy all of the following conditions with bladder cancer stage T2-4a, N0-1 according to 8th edition of American Joint Committee on Cancer
- Muscle invasive bladder cancer confirmed by cystoscopy
- Stage T2-4a, N0-1 in CT or MRI
- Performance status 0 or 1 based on ECOG
Show all 9Show fewer
- Patients agreed to provide the tissue sample obtained from TURB
- Diseases can be evaluated according to RECIST Version 1.1
- Patients who voluntarily agreed to informed consent
Who cannot join
- Patients with distant metastasis
- Patients with uncontrolled viral infection (HIV, HBV, HCV)
- Patient who are pregnant, or have possibility of pregnancy and are on lactating
- Hypersensitivity or history of allergic to the drug being used
- Patients with cerebrovascular disease, complications, and infections that are not medically controlled
- Patients with history of other malignant diseases within the past 5 years (excluding cured non-melanoma skin cancer or in situ cervical cancer)
- Those who are taking drugs that can cause drug interactions with chemotherapy
- Patients who withdraw consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei Severance Hospital
Seoul
Woong Sub Koom, +8210-8818-1356, MDGOLD@yuhs.ac
About this study
Official title: Development of a Genome-based Platform to Predict Patients That Can Achieve Bladder Preservation After Preoperative Chemoradiotherapy in Muscle Invasive Bladder Cancer Patients
This study is aimed to develop a genome-based platform to predict patients who can achieve bladder preservation after neoadjuvant treatment. The main treatments for invasive bladder cancer are radical cystectomy and intrapelvic lymph node dissection, but 50% of patients experience recurrence within 2 years after surgery. The recurrence after surgery is associate with T3 stage, the presence of invading soft tissue around the bladder and N1, lymph node metastasis. Therefore, various methods are being tried to reduce recurrence and metastasis, among which preoperative chemotherapy has been reported to increase survival rate. Based on this, preoperative chemotherapy followed by radical cystectomy are also recommended. However, there are several limitations; The surgery may be delayed in case of non-responsive to chemotherapy, the difficulty of tolerance of chemotherapy as the patients are relatively old in bladder cancer. Therefore, the preoperative concurrent chemoradiotherapy can be considered as a treatment effectively lower the recurrence. In several retrospective study has reported that preoperative radiation induces the down-staging and leads to prolonged progression free survival. However, after radical cystectomy, there is discomfort for patients regarding the removal of the bladder. Treating the bladder while preserving the bladder is getting its attention. The representative treatment is performing neoadjuvant concurrent chemotherapy followed by transurethral resection of bladder tumor. The bladder preserving treatment is performed in patients who have unresectable, locally advanced bladder cancer or are not medically appropriate for surgery. The 5-year overall survival is reported to be around 50-60%. To date, no clinical trial has been conducted to compare whether concurrent chemoradiotherapy can achieve the comparable clinical outcome as radical cystectomy in operable conditions. Therefore, in order to perform the bladder preserving treatment, a platform selecting patients who can preserve the bladder from bladder preserving treatment in advance is needed. Responsiveness to radiotherapy is a combination of various factors, and radiation sensitivity of tumors is the most important. The recent study has been demonstrated that physician can predict radiation sensitivity using genomic data. In this study, we intend to develop a platform that can predict responsiveness to radiotherapy and select patients who can preserve bladder using genomic information.
Read the detailed description
The treatment in this study is one of the standard treatments suggested by the NCCN guidelines. Bladder is preserved when neoadjuvant concurrent chemoradiotherapy is performed after transurethral resection of bladder tumor and complete remission is achieved through the cystoscopy. If complete response is not achieved, additional chemotherapy is performed. In case that complete response is not achieved through the cystoscopy after additional chemotherapy, cystectomy is performed. If complete response is achieved, the bladder is preserved.
Before treatment, the following are obtained; Medical history and physical examination, Tissue acquisition through transurethral resection of bladder tumor, Blood Test (CBC), Chemistry Test (SMA), staging through pelvic CT or MRI, cystoscopy, PET-CT or chest CT.
Cisplatin based concurrent chemoradiotherapy is conducted 4 times during the radiotherapy. AFter radiotherapy, the gemcitabine/cisplatin or gemcitabine/carboplatin treatment is performed. The target delineation is performed in 3mm simulation CT for radiotherapy. To consider the uncertainty of breath, the 4D CT is taken. GTV includes primary lesions and lymph node based on diagnostic CT, MRI, and PET-CT. CTV covers the entire bladder with microscopic margin of GTV. PTV1 is defined as extending 1.5cm from the entire bladder. PTV2 is defined as extending 1.5cm from GTV. Radiotherapy is performed using 3D conformal radiotherapy, intensity-modulated radiotherapy, volumetric modulated Arc therapy. Radiotherapy is administered daily, five times a week according to the NCCN guidelines. Each treatment is performed with bladder empty. radiotherapy is performed 20 fractions in total. For the first 15 fractions, 2.65Gy administered for PTV1 including the entire bladder. For rest 5 fractions, 3 Gy for PTV2 is administered. Totally, 55 Gy is administered.
If complete response is not achieved, the surgery and timing of surgery are determined by the urologist according to the location and severity of the primary cancer. The biopsy if performed using cystoscopy. If the findings are complete response, no additional treatment is performed, and if not, radical cystectomy is performed.
The treatment response is evaluated based on standard treatment process. During the treatment, the regular check up is conducted to evaluate the acute toxicity regarding treatment. After bladder preserving treatment, the pelvic CT, MRI and cystoscopy is used for evaluation.
The acquired specimens are ;used for RNA sequencing and organoid construction. The RNA sequencing is used to analyze the differentially expressed based on treatment response to neoadjuvant concurrent chemoradiotherapy.
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Keywords
- Bladder cancer, Bladder preservation, Genome-based platform, preoperative chemoradiotherapy
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Neo CCRT+Neo CTx +/- cystectomy | Patients receive neoadjuvant CCRT and neoadjuvant CTx. Radical cystectomy is performed depending on pathologic response. The patients showing clinical complete response after neoadjuvant CCRT and initially stage T2N0M0 are not treated with neoadjuvant chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder preservation rate
The rate of patients achieve bladder preservation without radical cystectomy
Measured: up to 2 years
Secondary outcomes (1)
Pathologic complete response rate
The rate of lesions detected as pathologically complete response after neoadjuvant treatment
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-Invasive Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Woong Sub Koom, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686149
- Sponsor's protocol ID
- 4-2020-1149
- Status last verified
- Dec 2020
- First submitted
- 24 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research related documents will be stored in a file with a separate password under the responsibility of the lead researcher and stored in a locked laboratory. These research-related records will be kept for 3 years from the time the research is completed, and after that, the research team will discard the documents. Tissue samples obtained from patients are subjected to genome analysis by extracting RNA and DNA. Patient registration information is encrypted and stored separately, and stored in freezer at -80°C until experimentation at Yonsei University Medical Research Institute under the supervision of the research director.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Genome-based Platform to Predict Patients That Can Achieve Bladder Preservation After Preoperative Chemoradiotherapy in Muscle Invasive Bladder Cancer Patients
- ClinicalTrials.gov ID
- NCT04686149
- Acronym / sponsor ID
- 4-2020-1149
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Keywords
- Bladder cancer, Bladder preservation, Genome-based platform, preoperative chemoradiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Dec 2020 (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.
This study is aimed to develop a genome-based platform to predict patients who can achieve bladder preservation after neoadjuvant treatment. The main treatments for invasive bladder cancer are radical cystectomy and intrapelvic lymph node dissection, but 50% of patients experience recurrence within 2 years after surgery. The recurrence after surgery is associate with T3 stage, the presence of invading soft tissue around the bladder and N1, lymph node metastasis. Therefore, various methods are being tried to reduce recurrence and metastasis, among which preoperative chemotherapy has been reported to increase survival rate. Based on this, preoperative chemotherapy followed by radical cystectomy are also recommended. However, there are several limitations; The surgery may be delayed in case of non-responsive to chemotherapy, the difficulty of tolerance of chemotherapy as the patients are relatively old in bladder cancer. Therefore, the preoperative concurrent chemoradiotherapy can be considered as a treatment effectively lower the recurrence. In several retrospective study has reported that preoperative radiation induces the down-staging and leads to prolonged progression free survival. However, after radical cystectomy, there is discomfort for patients regarding the removal of the bladder. Treating the bladder while preserving the bladder is getting its attention. The representative treatment is performing neoadjuvant concurrent chemotherapy followed by transurethral resection of bladder tumor. The bladder preserving treatment is performed in patients who have unresectable, locally advanced bladder cancer or are not medically appropriate for surgery. The 5-year overall survival is reported to be around 50-60%. To date, no clinical trial has been conducted to compare whether concurrent chemoradiotherapy can achieve the comparable clinical outcome as radical cystectomy in operable conditions. Therefore, in order to perform the bladder preserving treatment, a platform selecting patients who can preserve the bladder from bladder preserving treatment in advance is needed. Responsiveness to radiotherapy is a combination of various factors, and radiation sensitivity of tumors is the most important. The recent study has been demonstrated that physician can predict radiation sensitivity using genomic data. In this study, we intend to develop a platform that can predict responsiveness to radiotherapy and select patients who can preserve bladder using genomic information.
Detailed description
The treatment in this study is one of the standard treatments suggested by the NCCN guidelines. Bladder is preserved when neoadjuvant concurrent chemoradiotherapy is performed after transurethral resection of bladder tumor and complete remission is achieved through the cystoscopy. If complete response is not achieved, additional chemotherapy is performed. In case that complete response is not achieved through the cystoscopy after additional chemotherapy, cystectomy is performed. If complete response is achieved, the bladder is preserved.
Before treatment, the following are obtained; Medical history and physical examination, Tissue acquisition through transurethral resection of bladder tumor, Blood Test (CBC), Chemistry Test (SMA), staging through pelvic CT or MRI, cystoscopy, PET-CT or chest CT.
Cisplatin based concurrent chemoradiotherapy is conducted 4 times during the radiotherapy. AFter radiotherapy, the gemcitabine/cisplatin or gemcitabine/carboplatin treatment is performed. The target delineation is performed in 3mm simulation CT for radiotherapy. To consider the uncertainty of breath, the 4D CT is taken. GTV includes primary lesions and lymph node based on diagnostic CT, MRI, and PET-CT. CTV covers the entire bladder with microscopic margin of GTV. PTV1 is defined as extending 1.5cm from the entire bladder. PTV2 is defined as extending 1.5cm from GTV. Radiotherapy is performed using 3D conformal radiotherapy, intensity-modulated radiotherapy, volumetric modulated Arc therapy. Radiotherapy is administered daily, five times a week according to the NCCN guidelines. Each treatment is performed with bladder empty. radiotherapy is performed 20 fractions in total. For the first 15 fractions, 2.65Gy administered for PTV1 including the entire bladder. For rest 5 fractions, 3 Gy for PTV2 is administered. Totally, 55 Gy is administered.
If complete response is not achieved, the surgery and timing of surgery are determined by the urologist according to the location and severity of the primary cancer. The biopsy if performed using cystoscopy. If the findings are complete response, no additional treatment is performed, and if not, radical cystectomy is performed.
The treatment response is evaluated based on standard treatment process. During the treatment, the regular check up is conducted to evaluate the acute toxicity regarding treatment. After bladder preserving treatment, the pelvic CT, MRI and cystoscopy is used for evaluation.
The acquired specimens are ;used for RNA sequencing and organoid construction. The RNA sequencing is used to analyze the differentially expressed based on treatment response to neoadjuvant concurrent chemoradiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neo CCRT+Neo CTx +/- cystectomy | – | –Patients receive neoadjuvant CCRT and neoadjuvant CTx. Radical cystectomy is performed depending on pathologic response. The patients showing clinical complete response after neoadjuvant CCRT and initially stage T2N0M0 are not treated with neoadjuvant chemotherapy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with muscle invasive bladder cancer are subject to this trial. For bladder preservation, the patients receive neoadjvuvant CCRT. In case that clinical CR status obtained after CCRT in patients initally T2N0M0, no additional treatment is performed. Patients without clinical CR status are treated with neoadjuvant chemotherapy. After chemotherapy, the response is evaluated. If residual tumor is found, the radical cystectomy is performed.
Key inclusion criteria (9 listed)
- Patients older than 19 years old
- Clinically or histologically diagnosed urothelial carcinoma bladder cancer
- Patients who satisfy all of the following conditions with bladder cancer stage T2-4a, N0-1 according to 8th edition of American Joint Committee on Cancer
- Performance status 0 or 1 based on ECOG
- Patients agreed to provide the tissue sample obtained from TURB
Key exclusion criteria (8 listed)
- Patients with distant metastasis
- Patients with uncontrolled viral infection (HIV, HBV, HCV)
- Patient who are pregnant, or have possibility of pregnancy and are on lactating
- Hypersensitivity or history of allergic to the drug being used
- Patients with cerebrovascular disease, complications, and infections that are not medically controlled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bladder preservation rate
Time frame: up to 2 years
The rate of patients achieve bladder preservation without radical cystectomy
1 secondary outcome
Pathologic complete response rate
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Individual participant dataSharing planned: No. Research related documents will be stored in a file with a separate password under the responsibility of the lead researcher and stored in a locked laboratory. These research-related records will be kept for 3 years from the time the research is completed, and after that, the research team will discard the documents. Tissue samples obtained from patients are subjected to genome analysis by extracting RNA and DNA. Patient registration information is encrypted and stored separately, and stored in freezer at -80°C until experimentation at Yonsei University Medical Research Institute under the supervision of the research director.
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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.
Woong Sub Koom principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle-Invasive Bladder Carcinoma, run by Yonsei University at 1 site in South Korea.
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 9 inclusion and 8 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 Dec 2020. 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 South Korea. 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 Woong Sub Koom (+82-10-8818-1356, MDGOLD@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder preservation rate (time frame: up to 2 years). 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 Dec 2020; AzTrials last refreshed its copy on 4 Nov 2026.