Muscle-Invasive Bladder CarcinomaEarly Phase 1NCT07821177
Bladder Preservation or Cystectomy for MIBC
A Early Phase 1 study testing Gemzar, Cisplatin and Adrucil in people with Muscle-Invasive Bladder Carcinoma and Bladder Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
In this research study, investigators will assess whether it is feasible to use information from the genes of a tumor combined with evaluation of the tumor response to systemic therapy to determine if bladder sparing chemoradiation can be used or if surgery to remove the bladder, or radical cystectomy, is needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma, Bladder Cancer, Urothelial Carcinoma
- What is being tested?
- Gemzar, Cisplatin and Adrucil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Sep 2026to Sep 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Patient must have signed written informed consent indicating understanding of the purpose of the study and willingness to participate prior to any protocol-related procedures, including screening evaluation.
- Participants must have histologically confirmed cT2-cT4aN0M0 urothelial (transitional cell) carcinoma of the bladder. Mixed histology is acceptable as long as there is a majority component of urothelial carcinoma.
- Availability of baseline archival tumor tissue obtained for molecular analysis and correlative studies
- Age ≥ 18 years
- Candidate for radical cystectomy
- Cisplatin eligible
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants infected with human immunodeficiency virus on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Participants with evidence of chronic hepatitis B virus infection with an undetectable HBV viral load on suppressive therapy, if indicated, are eligible for this trial
- Participants with a history of hepatitis C virus (HCV) must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Participants with a prior or concurrent history of malignancy whose natural history of treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational protocol are eligible for this trial
- Participants must have adequate organ and marrow function as defined below:
- Leukocytes ≥3,000/mcL
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count ≥1,500/mcL
- Platelets ≥100,000/mcL
- International Normalized ratio ≤1.5 x institutional upper limit of normal (ULN) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
- Unless the patient is receiving anticoagulation therapy provided INR or PTT is within the therapeutic range of the intended anticoagulant
- Total bilirubin ≤ institutional upper limit of normal (ULN)
- This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed in consultation with their physician
- AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN
- Measured creatinine clearance ≥ 50 mL/min or calculated creatinine clearance 50mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- Males: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)
- Females: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for pre-menopausal female patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
- Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of treatment.
- Patient is willing and able to comply with the protocol for the duration of the trial
Who cannot join
- Patients with urothelial carcinoma of the ureter, urethra, or renal pelvis
- Contraindication for bladder radiation
- Inoperable primary tumor
- Any previous systemic chemotherapy or radiotherapy for bladder cancer
- Inflammatory bowel disease
- Patients who are receiving or have received any other investigational agents within 6 months of study entry
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- Child-Pugh class C hepatic impairment
- Receipt of the last dose of intravesical chemotherapy or biologic therapy ≤ 42 days (6 weeks) prior to the first dose of study drug for patients who have received prior intravesical chemotherapy or biologic therapy (e.g. BCG)
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, unstable cardiac arrhythmia, symptomatic interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
- Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
- Pregnant women are excluded from this study because chemotherapy and radiation have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued if the mother is treated with chemotherapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Pilot Study of Bladder Preservation or Cystectomy for Muscle-invasive Bladder Cancer Guided by Multi-omics: the B-PRECISE Study
In this research study, investigators will assess whether it is feasible to use information from the genes of a tumor combined with evaluation of the tumor response to systemic therapy to determine if bladder sparing chemoradiation can be used or if surgery to remove the bladder, or radical cystectomy, is needed.
Read the detailed description
This is a single-center, early phase 1 pilot study in which investigators will assess whether it is feasible to use information from the genes of a tumor combined with evaluation of the tumor response to systemic therapy to determine if bladder sparing chemoradiation can be used or if surgery to remove the bladder, or radical cystectomy, is needed.
Perioperative systemic therapy with surgical removal of the bladder or chemoradiation are standard treatments for muscle-invasive bladder cancer. The investigational part of this study is using specific information from the tumor and response to therapy to guide a standard-of-care treatment decision.
The research study procedures include screening for eligibility, standard of care systemic therapy, cystoscopy with biopsy, Magnetic Resonance Imaging studies, either bladder sparing chemoradiation or surgical removal of the bladder, blood tests, urine tests, questionnaires, and follow up visits.
Participation in this research study is expected to last for 2 years.
It is expected about 20 people will take part in this research study.
AstraZeneca Pharmaceuticals LP is supporting this research study by providing funding for the trial
Predicine is supporting this research study by providing funding for the molecular testing and tests required for research purposes.
Tufts University is providing funding for tests for research purposes.
- Being tested
- Gemzar, Cisplatin, Adrucil, Mitomycin, Radical Cystectomy
- Keywords
- Muscle-Invasive Bladder Carcinoma, Bladder Cancer, MIBC, urothelial carcinoma, bladder preservation
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemzarDrug
Nucleoside metabolic inhibitor, 200 mg single-dose vial, via intravenous infusion per standard of care.
CisplatinDrug
Platinum-based drug, 50 mg single-dose vial containing, via intravenous infusion per standard of care.
AdrucilDrug
Antineoplastic antimetabolite, 500 mg single-dose vial, via intravenous infusion per standard of care.
MitomycinDrug
Antibiotic, single-dose vials containing either 5, 10, 20, or 40 mg of mitomycin, via intravenous infusion per standard of care.
Radical CystectomyProcedure or surgery
Also called RC
Surgical removal of the bladder
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Chemoradiation Therapy | Experimental | Participants who are 1) molecular positive after standard of care neoadjuvant therapy and have a clinical complete response, OR 2) molecular negative after standard of care neoadjuvant therapy and have a clinical complete response with ≤cT1 disease can opt for chemoradiation therapy and will complete:
* Chemoradiation therapy of either:
* Predetermined dose of Cisplatin 1x weekly
* Predetermined dose of Gemcitabine 2x weekly
* Predetermined dose of 5FU continuous infusion for days 1-5 and 16-20 in combination with predetermined dose of Mitomycin 1x on day 1
* Predetermined dose of Cisplatin and 5FU 1x daily on days 1-3, 8-10, 15-17 for the duration of radiation.
* Radiation regimen per investigator discretion for 4 or 7 weeks.
* CT chest and CT or MRI of abdomen and pelvis.
* Follow Up Period Visits: CT chest and CT or MRI of abdomen and pelvis and cystoscopy with possible biopsy or removal of residual cancer tissue.
* End of study visit. Receives: Drug: Gemzar; Drug: Cisplatin; Drug: Adrucil; Drug: Mitomycin |
| Arm B: Radical Cystectomy | Experimental | Participants who have cT2 disease after standard of care neoadjuvant therapy will undergo standard of care RC and will complete:
* Radical cystectomy
* CT chest and CT or MRI of abdomen and pelvis.
* Follow Up Period Visits: CT chest and CT or MRI of abdomen and pelvis and cystoscopy with possible biopsy or removal of residual cancer tissue.
* Participants are eligible to receive standard of care adjuvant therapy
* End of study visit. Receives: Procedure: Radical Cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Failure Rate (FFR)
FFR defined as the proportion of participants that achieve feasibility failure. Feasibility is defined as the ability to derive interpretable information from ≥70% of evaluable patients from tumor genomics and/or transcriptomic studies before NAC plus mpMRI or cystoscopic evaluation and urine cytology to guide the patient toward an informed decision for bladder preservation chemoradiation vs. RC. Evaluable patients are those who initiate planned NAC.
Measured: Approximately 16 weeks after initiation of neoadjuvant chemotherapy
Secondary outcomes (8)
Clinical Complete Response (cCR) Rate
The cCR Rate is the proportion of participants achieving cCR. Patients will be defined as having a cCR if there is no residual disease (of any stage) on cystoscopy/TURBT/urine cytology and no evidence of disease on mpMRI.
Measured: Approximately 16 weeks after initiation of neoadjuvant chemotherapy
Bladder Preserving Rate
Bladder Preserving Rate is defined as the proportion of patients who preserve their bladders employing this strategy
Measured: Approximately 24 weeks after initiation of neoadjuvant chemotherapy, at time of definitive therapy
Median Bladder-Intact Disease-Free Survival (BIDFS)
Bladder-intact disease-free survival based on Laplan-Meier method is defined as the time from registration to the earlier of cystectomy, progression, or death due to any cause. Participants alive with an intact bladder and without disease progression are censored at date of last disease evaluation.
Measured: Disease evaluated radiolagically after completion of cisplatin-based neoadjuvant chemotherapy and after definitive treatment with chemoradiation/radical cystectomy.In long-term follow-up,data collected every 3-6 months for 2 years or progressive disease.
Recurrence Rate at 1 Year
Recurrence rate defined proportion of participants were diagnosed disease recurrence. Disease recurrence is defined as time from completion of NAC to development of a new primary urothelial carcinoma, local recurrence, or development of metastatic disease. New primary urothelial carcinoma and local recurrence will be evaluated using cystoscopy and metastatic disease will be measured using RECIST v. 1.1.
Measured: Relevant to this endpoint is at 1 year
Recurrence Rate at 2 Year
Recurrence rate defined proportion of participants were diagnosed disease recurrence. Disease recurrence is defined as time from completion of NAC to development of a new primary urothelial carcinoma, local recurrence, or development of metastatic disease. New primary urothelial carcinoma and local recurrence will be evaluated using cystoscopy and metastatic disease will be measured using RECIST v. 1.1.
Measured: Relevant to this endpoint is at 2 year
1-Year Overall Survival (OS)
1-year OS is a probability estimated using the Kaplan-Meier method; OS is defined as the time from study entry to death, or censored at date last known alive.
Measured: In long-term follow-up, participants were assessed every 6 months, up to 2 years. Relevant to this endpoint is the estimate at 1 year.
2-year Overall Survival (OS)
2-year OS is a probability estimated using the Kaplan-Meier method; OS is defined as the time from study entry to death, or censored at date last known alive.
Measured: In long-term follow-up, participants were assessed every 6 months, up to 2 years. Relevant to this endpoint is the estimate at 2 years.
Longitudinal assessment of quality of life using the Bladder Cancer Index
Bladder Cancer Index (BCI) data will be analyzed descriptively to characterize longitudinal changes in symptom severity and symptom interference across the prespecified study time points.. Exploratory analyses may assess BCI trajectories by molecular status, treatment response, and/or definitive treatment (chemoradiation therapy [CRT] versus radical cystectomy [RC]).
Measured: Data are collected baseline, after neoadjuvant chemotherapy, after definitive treatment (CRT/RC), during follow-up and off sutdy visit, with up to 2 years of follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start2 Sep 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2029 (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 Dana-Farber Cancer InstituteThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlene Mantia, Dana-Farber Cancer Institute
- Investigators
- Charlene Mantia, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821177
- Sponsor's protocol ID
- 23-409
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Bladder Preservation or Cystectomy for Muscle-invasive Bladder Cancer Guided by Multi-omics: the B-PRECISE Study
- ClinicalTrials.gov ID
- NCT07821177
- Acronym / sponsor ID
- 23-409
- Keywords
- Muscle-Invasive Bladder Carcinoma, Bladder Cancer, MIBC, urothelial carcinoma, bladder preservation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 15 Sep 2026 (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.
In this research study, investigators will assess whether it is feasible to use information from the genes of a tumor combined with evaluation of the tumor response to systemic therapy to determine if bladder sparing chemoradiation can be used or if surgery to remove the bladder, or radical cystectomy, is needed.
Detailed description
This is a single-center, early phase 1 pilot study in which investigators will assess whether it is feasible to use information from the genes of a tumor combined with evaluation of the tumor response to systemic therapy to determine if bladder sparing chemoradiation can be used or if surgery to remove the bladder, or radical cystectomy, is needed.
Perioperative systemic therapy with surgical removal of the bladder or chemoradiation are standard treatments for muscle-invasive bladder cancer. The investigational part of this study is using specific information from the tumor and response to therapy to guide a standard-of-care treatment decision.
The research study procedures include screening for eligibility, standard of care systemic therapy, cystoscopy with biopsy, Magnetic Resonance Imaging studies, either bladder sparing chemoradiation or surgical removal of the bladder, blood tests, urine tests, questionnaires, and follow up visits.
Participation in this research study is expected to last for 2 years.
It is expected about 20 people will take part in this research study.
AstraZeneca Pharmaceuticals LP is supporting this research study by providing funding for the trial
Predicine is supporting this research study by providing funding for the molecular testing and tests required for research purposes.
Tufts University is providing funding for tests for research purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Chemoradiation Therapy | Experimental | Drug: Gemzar, Drug: Cisplatin, Drug: Adrucil, Drug: MitomycinParticipants who are 1) molecular positive after standard of care neoadjuvant therapy and have a clinical complete response, OR 2) molecular negative after standard of care neoadjuvant therapy and have a clinical complete response with ≤cT1 disease can opt for chemoradiation therapy and will complete: * Chemoradiation therapy of either: * Predetermined dose of Cisplatin 1x weekly * Predetermined dose of Gemcitabine 2x weekly * Predetermined dose of 5FU continuous infusion for days 1-5 and 16-20 in combination with predetermined dose of Mitomycin 1x on day 1 * Predetermined dose of Cisplatin and 5FU 1x daily on days 1-3, 8-10, 15-17 for the duration of radiation. * Radiation regimen per investigator discretion for 4 or 7 weeks. * CT chest and CT or MRI of abdomen and pelvis. * Follow Up Period Visits: CT chest and CT or MRI of abdomen and pelvis and cystoscopy with possible biopsy or removal of residual cancer tissue. * End of study visit. |
| Arm B: Radical Cystectomy | Experimental | Procedure: Radical CystectomyParticipants who have cT2 disease after standard of care neoadjuvant therapy will undergo standard of care RC and will complete: * Radical cystectomy * CT chest and CT or MRI of abdomen and pelvis. * Follow Up Period Visits: CT chest and CT or MRI of abdomen and pelvis and cystoscopy with possible biopsy or removal of residual cancer tissue. * Participants are eligible to receive standard of care adjuvant therapy * End of study visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Patient must have signed written informed consent indicating understanding of the purpose of the study and willingness to participate prior to any protocol-related procedures, including screening evaluation.
- Participants must have histologically confirmed cT2-cT4aN0M0 urothelial (transitional cell) carcinoma of the bladder. Mixed histology is acceptable as long as there is a majority component of urothelial carcinoma.
- Availability of baseline archival tumor tissue obtained for molecular analysis and correlative studies
- Age ≥ 18 years
- Candidate for radical cystectomy
Key exclusion criteria (11 listed)
- Patients with urothelial carcinoma of the ureter, urethra, or renal pelvis
- Contraindication for bladder radiation
- Inoperable primary tumor
- Any previous systemic chemotherapy or radiotherapy for bladder cancer
- Inflammatory bowel 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 |
|---|---|---|
| GemzarNucleoside metabolic inhibitor, 200 mg single-dose vial, via intravenous infusion per standard of care. | Drug | Arm A: Chemoradiation Therapy |
| CisplatinPlatinum-based drug, 50 mg single-dose vial containing, via intravenous infusion per standard of care. | Drug | Arm A: Chemoradiation Therapy |
| AdrucilAntineoplastic antimetabolite, 500 mg single-dose vial, via intravenous infusion per standard of care. | Drug | Arm A: Chemoradiation Therapy |
| MitomycinAntibiotic, single-dose vials containing either 5, 10, 20, or 40 mg of mitomycin, via intravenous infusion per standard of care. | Drug | Arm A: Chemoradiation Therapy |
| Radical CystectomyAlso: RCSurgical removal of the bladder | Procedure or surgery | Arm B: Radical Cystectomy |
Primary outcome
Feasibility Failure Rate (FFR)
Time frame: Approximately 16 weeks after initiation of neoadjuvant chemotherapy
FFR defined as the proportion of participants that achieve feasibility failure. Feasibility is defined as the ability to derive interpretable information from ≥70% of evaluable patients from tumor genomics and/or transcriptomic studies before NAC plus mpMRI or cystoscopic evaluation and urine cytology to guide the patient toward an informed decision for bladder preservation chemoradiation vs. RC. Evaluable patients are those who initiate planned NAC.
8 secondary outcomes
Clinical Complete Response (cCR) Rate
Time frame: Approximately 16 weeks after initiation of neoadjuvant chemotherapy
Bladder Preserving Rate
Time frame: Approximately 24 weeks after initiation of neoadjuvant chemotherapy, at time of definitive therapy
Median Bladder-Intact Disease-Free Survival (BIDFS)
Time frame: Disease evaluated radiolagically after completion of cisplatin-based neoadjuvant chemotherapy and after definitive treatment with chemoradiation/radical cystectomy.In long-term follow-up,data collected every 3-6 months for 2 years or progressive disease.
Recurrence Rate at 1 Year
Time frame: Relevant to this endpoint is at 1 year
Recurrence Rate at 2 Year
Time frame: Relevant to this endpoint is at 2 year
1-Year Overall Survival (OS)
Time frame: In long-term follow-up, participants were assessed every 6 months, up to 2 years. Relevant to this endpoint is the estimate at 1 year.
2-year Overall Survival (OS)
Time frame: In long-term follow-up, participants were assessed every 6 months, up to 2 years. Relevant to this endpoint is the estimate at 2 years.
Longitudinal assessment of quality of life using the Bladder Cancer Index
Time frame: Data are collected baseline, after neoadjuvant chemotherapy, after definitive treatment (CRT/RC), during follow-up and off sutdy visit, with up to 2 years of follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Charlene Mantia, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gemzar, Cisplatin and Adrucil in people with Muscle-Invasive Bladder Carcinoma and Bladder Cancer, run by Dana-Farber Cancer Institute at 2 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 29 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility Failure Rate (FFR) (time frame: Approximately 16 weeks after initiation of neoadjuvant chemotherapy). 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 15 Sep 2026.