An Early Phase 1 interventional study of Gemzar and Cisplatin in Muscle-Invasive Bladder Carcinoma, Bladder Cancer and Urothelial Carcinoma, sponsored by Dana-Farber Cancer Institute. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Dana-Farber Cancer Institute · Early Phase 1, Interventional, and Treatment
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.
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.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must have adequate organ and marrow function as defined below:
Evidence of 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Gemzar · Drug: Cisplatin · Drug: Adrucil · Drug: Mitomycin
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.
Procedure: Radical Cystectomy
Nucleoside metabolic inhibitor, 200 mg single-dose vial, via intravenous infusion per standard of care.
Platinum-based drug, 50 mg single-dose vial containing, via intravenous infusion per standard of care.
Antineoplastic antimetabolite, 500 mg single-dose vial, via intravenous infusion per standard of care.
Antibiotic, single-dose vials containing either 5, 10, 20, or 40 mg of mitomycin, via intravenous infusion per standard of care.
Surgical removal of the bladder
Also known as: RC
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.
Time frame: Approximately 16 weeks after initiation of neoadjuvant chemotherapy
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.
Time frame: 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
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
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)
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.
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
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 \[RC\]).
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.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data can be shared no earlier than 1 year following the date of publication
Access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Gemcitabine · Cisplatin · Fluorouracil · Mitomycin
Dana-Farber Cancer Institute →