Muscle Invasive Bladder CancerNCT02716896
Radical Cystectomy Compared With Chemoradiation for Muscle Invasive Bladder Cancer
A study testing Radiation and chemoradiation and Radical cystectomy in people with Muscle Invasive Bladder Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Currently the standard treatment of muscle invasive bladder cancer is the complete removal of bladder and adjacent organs, such as prostate or ovaries. Radical cystectomy is fraught with complications and risk of death. The researchers hope to learn if chemoradiation (i.e. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Muscle Invasive Bladder Cancer
- What is being tested?
- Radiation and chemoradiation and Radical cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 26 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically (histologically) proven diagnosis of primary carcinoma of the bladder (transitional cell cancer) within 8 weeks of registration. Operable patients whose tumors are primary carcinomas of the bladder and exhibit histologic evidence of muscularis propria invasion and are AJCC clinical stages T2-T4a, Nx or N0, M0
- If radiologic evaluation of a lymph node is interpreted as "positive", this must be evaluated further either by lymphadenectomy or percutaneous needle biopsy. Patients with histologically or cytologically confirmed node metastases or any other metastases will not be eligible.
- Patients must have an adequately functioning bladder after thorough evaluation by an urologist and have undergone as thorough a transurethral resection of the bladder tumor as is judged safely possible.
- Patients must be considered able to tolerate systemic chemotherapy combined with pelvic radiation therapy, and a radical cystectomy by the joint agreement of the participating Urologist, Radiation Oncologist, and Medical Oncologist.
- History and physical examination including weight, performance status, and body surface area within 8 weeks prior to study registration
- Zubrod Performance Status 0-2
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- Age ≥ 18;
- CBC (Complete blood count)/differential obtained no more than 4 weeks prior to registration on study, with adequate bone marrow function defined as follows:
- WBC (white bloodcell count) ≥ 4000/ml
- Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3;
- Platelets ≥ 100,000 cells/mm3;
- Hemoglobin ≥ 10.0 mg/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable.);
- Serum creatinine of 1.5 mg% or less; serum bilirubin of 2.0 mg% or less; creatinine clearance of 60 ml/min or greater no more than 4 weeks prior to registration; Note: Calculated creatinine clearance is permissible. If the creatinine clearance is > 60 ml/min, then a serum creatinine of up to 1.8 mg% is allowable at the discretion of the principle investigator;
- Serum pregnancy test for female patients of childbearing potential, ≤ 72 hours prior to study entry; women of childbearing potential and male participants must practice adequate contraception.
- Patient must be able to provide study-specific informed consent prior to study entry
Who cannot join
- Unable and unwilling to provide informed consent
- Evidence of distant metastases or histologically or cytologically proven lymph node metastases
- Previous systemic chemotherapy (for any cancer) or pelvic radiation therapy
- A prior or concurrent malignancy of any other site or histology unless the patient has been disease-free for ≥ 5 years except for non-melanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix
- Patients judged not to be candidates for radical cystectomy; patients with pN (plasma nitrate)+ or T4b disease are considered to have unresectable disease
- Patients receiving any drugs that have potential nephrotoxicity or ototoxicity (such as an aminoglycoside)
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- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
- Transmural myocardial infarction within the last 6 months;
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note,however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Is pregnant; women of childbearing potential and male participants unwilling to practice adequate contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78829
About this study
Official title: Radical Cystectomy Compared With Chemoradiation for Muscle Invasive Bladder Cancer: A Pilot, Randomized-Controlled Non-Inferiority Trial
Currently the standard treatment of muscle invasive bladder cancer is the complete removal of bladder and adjacent organs, such as prostate or ovaries. Radical cystectomy is fraught with complications and risk of death. The researchers hope to learn if chemoradiation (i.e. using chemotherapy and radiation), also an acceptable treatment for muscle invasive bladder cancer, can be used a good alternative therapy option.
Read the detailed description
Currently the standard treatment of muscle invasive bladder cancer is the complete removal of bladder and adjacent organs, such as prostate or ovaries. Such procedure is highly invasive and undesirable for some patients.
The researchers hope to learn if chemoradiation, using chemotherapy and radiation, can be a good alternative therapy option. Chemoradiation therapy is also currently considered an acceptable clinical approach but is typically used for treatment in patients with muscle invasive bladder cancer who have other medical issues that might cause complications during or after undergoing surgery. Disease free survival at 5 years is better for those who had their bladder removed, but overall survival rates for chemoradiation therapy patients are comparable between the two approaches.
- Conditions
- Muscle Invasive Bladder Cancer
- Being tested
- Radiation and chemoradiation, Radical cystectomy
- Keywords
- cystectomy, radiation, chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation and chemoradiationRadiation
Also called Chemoradiation
Radiation and chemotherapy will be administered concurrently to those who are randomized to this group.
Radical cystectomyProcedure or surgery
Also called Surgery
Radical cystectomy will be performed on those who are randomized to this group.
| Study group | Role | What they receive |
|---|---|---|
| Surgery (radical cystectomy) | Active comparator | In brief, radical cystectomy is the removal of the entire bladder, nearby lymph nodes (lymphadenectomy), part of the urethra, and nearby organs that may contain cancer cells. In men the prostate, the seminal vesicles, and part of the vas deferens are also removed. In women the cervix, the uterus, the ovaries, the fallopian tubes, and part of the vagina are also removed. Participants in this group may also undergo neoadjuvant chemotherapy prior to the surgery. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, Glomerular Filtration rate (GFR), participant's preference, and availability of chemotherapeutic regimen. Receives: Procedure: Radical cystectomy |
| Radiation and Chemoradiation | Active comparator | Those randomized to this group will undergo systematic chemotherapy and radiation. In brief, participants will receive 33-36 daily fractions of radiation therapy 5 days a week. Concurrently, radiosensitizing chemotherapy involves either cisplatin plus 5-fluorouracil (5-FU) or mitomycin C (MMC) plus 5-FU. Other concurrent chemotherapy regimens utilized include paclitaxel and gemcitabine. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, availability of chemotherapeutic regimen. Receives: Radiation: Radiation and chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Participants Adhere to the Assigned Treatment
Number of randomized participants that progressed to one year on treatment
Measured: One year
Total Number of Participants Withdraw From the Study
Number of randomized participants who were withdrawn from the study by the investigator, or who voluntarily withdrew
Measured: One year
Total Number of Participants Completed the Study
Number of randomized subjects who completed the study to one year
Measured: One year
Secondary outcomes (4)
Change From Baseline and Year 1 in Health Related Quality of Life Measures
Questionnaires such as FACT-Bl (functional assessment of cancer therapyfor patients with bladder cancer), Katz ADL (Katz Index of Independence in Activities of Daily Living), and EORTC (European Organization for Research and Treatment of Cancer), all surveys used to assess quality of life, will be used to measure the changes.
Measured: One year
Total Number of Participants Who Are Able to Keep Their Bladder Within the Time Frame of the Study
Number of participants that were randomized who did not have bladder cystectomy during the one year study period
Measured: One year
Total Number of Participants Who Remained Progression-free Within the Time Frame of the Study
Number of participants who completed the study whose disease state did not worsen during participation
Measured: One year
Change From Baseline Level to Year 1 on Genomic Markers After Chemoradiation
Genomic markers will be isolated from the research biological samples, and then measured by tissue RNA microarray.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startMay 2016
- Primary completion26 Mar 2018
- Study completion26 Mar 2018
Why it stopped: Study ended due to lack of eligible subjects and funding not renewing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716896
- Sponsor's protocol ID
- HSC2015-620H
- Other IDs
- UL1TR001120
- Status last verified
- Nov 2019
- First submitted
- 15 Oct 2015
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radical Cystectomy Compared With Chemoradiation for Muscle Invasive Bladder Cancer: A Pilot, Randomized-Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT02716896
- Acronym / sponsor ID
- HSC2015-620H
- Conditions
- Muscle Invasive Bladder Cancer
- Keywords
- cystectomy, radiation, chemotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study ended due to lack of eligible subjects and funding not renewing
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Posted 12 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently the standard treatment of muscle invasive bladder cancer is the complete removal of bladder and adjacent organs, such as prostate or ovaries. Radical cystectomy is fraught with complications and risk of death. The researchers hope to learn if chemoradiation (i.e. using chemotherapy and radiation), also an acceptable treatment for muscle invasive bladder cancer, can be used a good alternative therapy option.
Detailed description
Currently the standard treatment of muscle invasive bladder cancer is the complete removal of bladder and adjacent organs, such as prostate or ovaries. Such procedure is highly invasive and undesirable for some patients.
The researchers hope to learn if chemoradiation, using chemotherapy and radiation, can be a good alternative therapy option. Chemoradiation therapy is also currently considered an acceptable clinical approach but is typically used for treatment in patients with muscle invasive bladder cancer who have other medical issues that might cause complications during or after undergoing surgery. Disease free survival at 5 years is better for those who had their bladder removed, but overall survival rates for chemoradiation therapy patients are comparable between the two approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery (radical cystectomy) | Active comparator | Procedure: Radical cystectomyIn brief, radical cystectomy is the removal of the entire bladder, nearby lymph nodes (lymphadenectomy), part of the urethra, and nearby organs that may contain cancer cells. In men the prostate, the seminal vesicles, and part of the vas deferens are also removed. In women the cervix, the uterus, the ovaries, the fallopian tubes, and part of the vagina are also removed. Participants in this group may also undergo neoadjuvant chemotherapy prior to the surgery. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, Glomerular Filtration rate (GFR), participant's preference, and availability of chemotherapeutic regimen. |
| Radiation and Chemoradiation | Active comparator | Radiation: Radiation and chemoradiationThose randomized to this group will undergo systematic chemotherapy and radiation. In brief, participants will receive 33-36 daily fractions of radiation therapy 5 days a week. Concurrently, radiosensitizing chemotherapy involves either cisplatin plus 5-fluorouracil (5-FU) or mitomycin C (MMC) plus 5-FU. Other concurrent chemotherapy regimens utilized include paclitaxel and gemcitabine. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, availability of chemotherapeutic regimen. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Pathologically (histologically) proven diagnosis of primary carcinoma of the bladder (transitional cell cancer) within 8 weeks of registration. Operable patients whose tumors are primary carcinomas of the bladder and exhibit histologic evidence of muscularis propria invasion and are AJCC clinical stages T2-T4a, Nx or N0, M0
- If radiologic evaluation of a lymph node is interpreted as "positive", this must be evaluated further either by lymphadenectomy or percutaneous needle biopsy. Patients with histologically or cytologically confirmed node metastases or any other metastases will not be eligible.
- Patients must have an adequately functioning bladder after thorough evaluation by an urologist and have undergone as thorough a transurethral resection of the bladder tumor as is judged safely possible.
- Patients must be considered able to tolerate systemic chemotherapy combined with pelvic radiation therapy, and a radical cystectomy by the joint agreement of the participating Urologist, Radiation Oncologist, and Medical Oncologist.
- History and physical examination including weight, performance status, and body surface area within 8 weeks prior to study registration
Key exclusion criteria (15 listed)
- Unable and unwilling to provide informed consent
- Evidence of distant metastases or histologically or cytologically proven lymph node metastases
- Previous systemic chemotherapy (for any cancer) or pelvic radiation therapy
- A prior or concurrent malignancy of any other site or histology unless the patient has been disease-free for ≥ 5 years except for non-melanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix
- Patients judged not to be candidates for radical cystectomy; patients with pN (plasma nitrate)+ or T4b disease are considered to have unresectable disease
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 |
|---|---|---|
| Radiation and chemoradiationAlso: ChemoradiationRadiation and chemotherapy will be administered concurrently to those who are randomized to this group. | Radiation | Radiation and Chemoradiation |
| Radical cystectomyAlso: SurgeryRadical cystectomy will be performed on those who are randomized to this group. | Procedure or surgery | Surgery (radical cystectomy) |
Primary outcome
Total Number of Participants Adhere to the Assigned Treatment
Time frame: One year
Number of randomized participants that progressed to one year on treatment
Total Number of Participants Withdraw From the Study
Time frame: One year
Number of randomized participants who were withdrawn from the study by the investigator, or who voluntarily withdrew
Total Number of Participants Completed the Study
Time frame: One year
Number of randomized subjects who completed the study to one year
4 secondary outcomes
Change From Baseline and Year 1 in Health Related Quality of Life Measures
Time frame: One year
Total Number of Participants Who Are Able to Keep Their Bladder Within the Time Frame of the Study
Time frame: One year
Total Number of Participants Who Remained Progression-free Within the Time Frame of the Study
Time frame: One year
Change From Baseline Level to Year 1 on Genomic Markers After Chemoradiation
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Screening logs from a pilot randomized controlled trial of radical vs chemoradiation therapy for muscle-invasive bladder cancerLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation and chemoradiation and Radical cystectomy in people with Muscle Invasive Bladder Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 15 inclusion and 15 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: stopped early, as of the sponsor's last update on 25 Nov 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Participants Adhere to the Assigned Treatment (time frame: One year). 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 25 Nov 2019.