Bladder CancerPhase 2NCT00981656
Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer
A Phase 2 study testing cisplatin, 5-fluorouracil and Mitomycin in people with Bladder Cancer, run by Radiation Therapy Oncology Group at 13 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- cisplatin, 5-fluorouracil and Mitomycin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 13 sitesUnited States
- Study dates
- Nov 2009to 15 Aug 2023
- Phase
- Phase 2
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven diagnosis of carcinoma of the bladder within 105 days prior to registration.
- Operable patients whose initial tumor is a primary high grade urothelial carcinoma of the bladder exhibiting histologic evidence of invasion into the lamina propria (disease clinical stage T1) or a high grade stage Ta urothelial carcinoma without hydronephrosis; patients who have involvement of the prostatic urethra with urothelial carcinoma and have no evidence of stromal invasion of the prostate remain eligible. If the patient's initial tumor was a high grade stage Ta urothelial carcinoma then his/her recurrent tumor must be a high grade stage T1 urothelial carcinoma to be eligible.
- Patients must have a high grade urothelial carcinoma stage Ta or T1 that has recurred within 540 days after completion of the initial treatment [TURBT and intravesical Bacillus Calmette Guerin (BCG) immunotherapy] or on initial presentation with a T1 high grade tumor, the participating urologist judged BCG therapy is contraindicated or unsuitable because the patient is found to be intolerant of BCG therapy or because this patient may be immuno-compromised in ways other than that mentioned in Exclusion Criteria 2.8 or because the patient refuses BCG therapy.
- With the presentations as described in Section 2, the participating urologist judges that the standard next therapy, based on present urologic guidelines for this patient, is radical cystectomy.
- If radiologic evaluation of a lymph node is interpreted as "positive", this must be evaluated further either by lymphadenectomy or by percutaneous needle biopsy. Patients with histologically or cytologically confirmed node metastases will not be eligible.
- Patients must have an adequately functioning bladder as judged by the participating urologist and radiation oncologist and have undergone a re-staging TURBT by the participating urologist that showed (or was present in the outside pathology specimen) a high grade stage Ta or T1 tumor with uninvolved muscularis propria in the specimen and, if on prostatic urethral biopsy mucosal carcinoma is present, there is no evidence on biopsy in the prostatic stroma of tumor invasion.
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- Patient must be considered able to tolerate systemic chemotherapy combined with pelvic radiation therapy, and a radical cystectomy (if necessary) by the joint agreement of the participating urologist, radiation oncologist, and medical oncologist.
- Appropriate stage for protocol entry, based upon the following minimum diagnostic workup within 60 days prior to registration:
- History/physical examination including weight, performance data, body surface area
- Zubrod Performance Status ≤ 1
- Age ≥ 18
- Complete blood count (CBC)/differential obtained no more than 30 days prior to registration on study, with adequate bone marrow function defined as follows:
- White blood cell count (WBC) ≥ 4,000/ml
- Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable.)
- If the patient is to be treated with cisplatin, the serum creatinine should be ≤ 1.5 mg%; serum bilirubin of ≤ 2.0 mg%
- Glomerular filtration rate (GFR) > 25 ml/min [For patients receiving cisplatin, GFR ≥ 60 ml/min]
- 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
- Evidence of tumor-related hydronephrosis
- Evidence of distant metastases or histologically or cytologically proven lymph node metastases
- Prior systemic chemotherapy for bladder cancer; prior chemotherapy for a different cancer is allowable
- 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 or a urothelial carcinoma of the upper urinary tract stage pTa, pTis or pT1 that has not been free of disease after treatment for more than a 2-year period
- Patients with pN+ or > T1 disease or who have not had a visibly complete TURBT
- Patients receiving any drugs that have potential nephrotoxicity or ototoxicity (such as an aminoglycoside)
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- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- 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 the current Centers for Disease Control and Prevention (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.
- Prior allergic reaction to the study drugs (cisplatin, mitomycin, 5FU) involved in this
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090
Emory Crawford Long Hospital
Atlanta, Georgia, 30308
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
St. Agnes Hospital Cancer Center
Baltimore, Maryland, 21229
Barberton Citizens Hospital
Barberton, Ohio, 44203
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, 02721
University of Texas Medical Branch
Galveston, Texas, 77555-0361
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002
Beth Israel Medical Center - Petrie Division
New York, New York, 10003-3803
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
Norris Cotton Cancer Center - North
Saint Johnsbury, Vermont, 05819
Cancer Care Center, Incorporated
Salem, Ohio, 44460
Cancer Treatment Center
Wooster, Ohio, 44691
About this study
Official title: A Phase II Protocol for Patients With Stage T1 Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent With Radiosensitizing Chemotherapy Following a Thorough Transurethral Surgical Re-Staging
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, mitomycin C, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well radiation therapy given together with chemotherapy works in treating patients with stage I bladder cancer.
Read the detailed description
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and annually thereafter until termination of the study.
- Conditions
- Bladder Cancer
- Being tested
- cisplatin, 5-fluorouracil, Mitomycin, Three-Dimensional Conformal Radiation Therapy
- Keywords
- stage I bladder cancer, transitional cell carcinoma of the bladder
- 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.
cisplatinDrug
60-minute intravenous (IV) infusion of 15 mg/m^2 on days 1, 2, 3, 15, 16, 17, 29, 30, and 31 of radiation treatment.
5-fluorouracilDrug
Also called 5FU
Continuous IV infusion of 500 mg/m^2/24 hrs for 5 consecutive days during weeks 1 and 4 of radiation treatment.
MitomycinDrug
IV bolus dose of 12 mg/m^2 on day 1 of radiation treatment.
Three-Dimensional Conformal Radiation TherapyRadiation
Also called 3DCRT, 3D CRT
Total dose to the gross bladder volume of 61.2 Gy as 34 daily fractions 5 days/week, for approximately 7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 3DCRT + CT | Experimental | Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT). Receives: Drug: cisplatin; Drug: 5-fluorouracil; Drug: Mitomycin; Radiation: Three-Dimensional Conformal Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Free From Radical Cystectomy at 3 Years
The number of participants who did not undergo a radical cystectomy within three years divided by the number of analyzed participants, presented with the 97.5% lower bound.
Measured: Three years from registration
Secondary outcomes (11)
Percentage of Participants Free From Radical Cystectomy at 5 Years
The number of participants who did not undergo a radical cystectomy within five years divided by the number of analyzed participants.
Measured: Five years from registration
Percent of Participants With Distant Disease Progression at 3 Years
Distant disease progression is defined as the first appearance of disease in a non-regional lymph node, solid organ or bone. Time to distant disease progression is defined as time from registration to the date of first distant disease progression, last known follow-up (censored), or death without distant disease progression (competing risk). Distant disease progression rate is estimated using the cumulative incidence method.
Measured: From registration to three years
Percent of Participants With Distant Disease Progression at 5 Years
Distant disease progression is defined as the first appearance of disease in a non-regional lymph node, solid organ or bone. Time to distant disease progression is defined as time from registration to the date of first distant disease progression, last known follow-up (censored), or death without distant disease progression (competing risk). Distant disease progression rate is estimated using the cumulative incidence method.
Measured: From registration to five years
Percentage of Participants With Progression to Tumor Stage T2 or Greater at 3 Years
Primary tumor stage T2 = tumor invades muscle; T3 = tumor invades perivesical tissue; T4 = tumor invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall. Time to progression is defined as time from registration to the date of first progression, last known follow-up (censored), or death without tumor progression (competing risk). Tumor progression rates was to be estimated using the cumulative incidence method.
Measured: From registration to three years
Percentage of Participants With Progression to Tumor Stage T2 or Greater at 5 Years
Primary tumor stage T2 = tumor invades muscle; T3 = tumor invades perivesical tissue; T4 = tumor invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall. Time to progression is defined as time from registration to the date of first progression, last known follow-up (censored), or death without tumor progression (competing risk). Tumor progression rate was to be estimated using the cumulative incidence method.
Measured: From registration to five years
Percentage of Participants Who Have Died From Bladder Cancer at 5 Years (Disease-specific Survival)
Time to death from bladder cancer is defined as time from registration to death from bladder cancer, last known follow-up (censored), or death from other cause (competing risk). More specifically, death absent a distant metastasis, death from non-bladder cancer, and death absent local recurrence comprise the competing risk. Death from bladder cancer rate is estimated using the cumulative incidence method.
Measured: From registration to five years
Percentage of Participants Alive at 3 Years
Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.
Measured: From registration to three years
Percentage of Participants Alive at 5 Years
Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.
Measured: From registration to five years
Distribution of Participants by Highest Grade Adverse Event
Common Terminology Criteria for Adverse Events (CTCAE) version 4 grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Measured: Adverse events are evaluated 8-10 weeks after end of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for 3 years, then annually. Maximum follow-up at time of reporting was 8.6 years.
Percentage of Participants With Local Recurrence at 3 Years
Time to local recurrence is defined as time from registration to the date of first local recurrence, last known follow-up (censored), or death without local recurrence (competing risk). Local recurrence rate is estimated using the cumulative incidence method.
Measured: From registration to three years
American Urological Association Total Symptom Score at Baseline and at 3 Years
The American Urological Association Total symptom score measures the severity of enlarged prostate symptoms. Possible scores range from 0 to 35, with higher scores indicating worse symptoms.
Measured: Baseline and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2021
- Study completion15 Aug 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Responsible party
- Sponsor
- Investigators
- William U. Shipley, MD, FACR, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981656
- Sponsor's protocol ID
- RTOG 0926
- Other IDs
- CDR0000654727, NCI-2011-01974
- Status last verified
- Aug 2023
- First submitted
- 19 Sep 2009
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dahl DM, Rodgers JP, Shipley WU, Michaelson MD, Wu CL, Parker W, Jani AB, Cury FL, Hudes RS, Michalski JM, Hartford AC, Song D, Citrin DE, Karrison TG, Sandler HM, Feng FY, Efstathiou JA. Bladder-Preserving Trimodality Treatment for High-Grade T1 Bladder Cancer: Results From Phase II Protocol NRG Oncology/RTOG 0926. J Clin Oncol. 2024 Dec;42(34):4095-4102. doi: 10.1200/JCO.23.02510. Epub 2024 Sep 3.
PubMed 39226514
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Protocol for Patients With Stage T1 Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent With Radiosensitizing Chemotherapy Following a Thorough Transurethral Surgical Re-Staging
- ClinicalTrials.gov ID
- NCT00981656
- Acronym / sponsor ID
- RTOG 0926
- Conditions
- Bladder Cancer
- Keywords
- stage I bladder cancer, transitional cell carcinoma of the bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Study start
- Nov 2009 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 25 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, mitomycin C, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well radiation therapy given together with chemotherapy works in treating patients with stage I bladder cancer.
Detailed description
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and annually thereafter until termination of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3DCRT + CT | Experimental | Drug: cisplatin, Drug: 5-fluorouracil, Drug: Mitomycin, Radiation: Three-Dimensional Conformal Radiation TherapyConcurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT). |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Pathologically proven diagnosis of carcinoma of the bladder within 105 days prior to registration.
- Patients must have a high grade urothelial carcinoma stage Ta or T1 that has recurred within 540 days after completion of the initial treatment [TURBT and intravesical Bacillus Calmette Guerin (BCG) immunotherapy] or on initial presentation with a T1 high grade tumor, the participating urologist judged BCG therapy is contraindicated or unsuitable because the patient is found to be intolerant of BCG therapy or because this patient may be immuno-compromised in ways other than that mentioned in Exclusion Criteria 2.8 or because the patient refuses BCG therapy.
- With the presentations as described in Section 2, the participating urologist judges that the standard next therapy, based on present urologic guidelines for this patient, is radical cystectomy.
- If radiologic evaluation of a lymph node is interpreted as "positive", this must be evaluated further either by lymphadenectomy or by percutaneous needle biopsy. Patients with histologically or cytologically confirmed node metastases will not be eligible.
- Patients must have an adequately functioning bladder as judged by the participating urologist and radiation oncologist and have undergone a re-staging TURBT by the participating urologist that showed (or was present in the outside pathology specimen) a high grade stage Ta or T1 tumor with uninvolved muscularis propria in the specimen and, if on prostatic urethral biopsy mucosal carcinoma is present, there is no evidence on biopsy in the prostatic stroma of tumor invasion.
Key exclusion criteria (16 listed)
- Evidence of tumor-related hydronephrosis
- Evidence of distant metastases or histologically or cytologically proven lymph node metastases
- Prior systemic chemotherapy for bladder cancer; prior chemotherapy for a different cancer is allowable
- 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 or a urothelial carcinoma of the upper urinary tract stage pTa, pTis or pT1 that has not been free of disease after treatment for more than a 2-year period
- Patients with pN+ or > T1 disease or who have not had a visibly complete TURBT
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 |
|---|---|---|
| cisplatin60-minute intravenous (IV) infusion of 15 mg/m^2 on days 1, 2, 3, 15, 16, 17, 29, 30, and 31 of radiation treatment. | Drug | 3DCRT + CT |
| 5-fluorouracilAlso: 5FUContinuous IV infusion of 500 mg/m^2/24 hrs for 5 consecutive days during weeks 1 and 4 of radiation treatment. | Drug | 3DCRT + CT |
| MitomycinIV bolus dose of 12 mg/m^2 on day 1 of radiation treatment. | Drug | 3DCRT + CT |
| Three-Dimensional Conformal Radiation TherapyAlso: 3DCRT, 3D CRTTotal dose to the gross bladder volume of 61.2 Gy as 34 daily fractions 5 days/week, for approximately 7 weeks. | Radiation | 3DCRT + CT |
Primary outcome
Percentage of Participants Free From Radical Cystectomy at 3 Years
Time frame: Three years from registration
The number of participants who did not undergo a radical cystectomy within three years divided by the number of analyzed participants, presented with the 97.5% lower bound.
11 secondary outcomes
Percentage of Participants Free From Radical Cystectomy at 5 Years
Time frame: Five years from registration
Percent of Participants With Distant Disease Progression at 3 Years
Time frame: From registration to three years
Percent of Participants With Distant Disease Progression at 5 Years
Time frame: From registration to five years
Percentage of Participants With Progression to Tumor Stage T2 or Greater at 3 Years
Time frame: From registration to three years
Percentage of Participants With Progression to Tumor Stage T2 or Greater at 5 Years
Time frame: From registration to five years
Percentage of Participants Who Have Died From Bladder Cancer at 5 Years (Disease-specific Survival)
Time frame: From registration to five years
Percentage of Participants Alive at 3 Years
Time frame: From registration to three years
Percentage of Participants Alive at 5 Years
Time frame: From registration to five years
Distribution of Participants by Highest Grade Adverse Event
Time frame: Adverse events are evaluated 8-10 weeks after end of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for 3 years, then annually. Maximum follow-up at time of reporting was 8.6 years.
Percentage of Participants With Local Recurrence at 3 Years
Time frame: From registration to three years
American Urological Association Total Symptom Score at Baseline and at 3 Years
Time frame: Baseline and 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39226514Dahl DM, Rodgers JP, Shipley WU, Michaelson MD, Wu CL, Parker W, Jani AB, Cury FL, Hudes RS, Michalski JM, Hartford AC, Song D, Citrin DE, Karrison TG, Sandler HM, Feng FY, Efstathiou JA. Bladder-Preserving Trimodality Treatment for High-Grade T1 Bladder Cancer: Results From Phase II Protocol NRG Oncology/RTOG 0926. J Clin Oncol. 2024 Dec;42(34):4095-4102. doi: 10.1200/JCO.23.02510. Epub 2024 Sep 3.
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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.
William U. Shipley, MD, FACR principal investigator
Massachusetts General Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin, 5-fluorouracil and Mitomycin in people with Bladder Cancer, run by Radiation Therapy Oncology Group at 13 sites 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 20 inclusion and 16 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2022). 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?
Percentage of Participants Free From Radical Cystectomy at 3 Years (time frame: Three years from registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00981656, which also lists 1 linked publication.
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 19 Sep 2024.