Bladder CancerPhase 1NCT01104350
Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
A Phase 1 study testing external radiation therapy with gemcitabine in people with Bladder Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
The purpose of this study is to test the safety of different amounts (doses) of external radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- external radiation therapy with gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2010to 3 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MSKCC-reviewed pathologically proven diagnosis of primary bladder urothelial carcinoma without evidence of regional (nodal) or distant spread (cT1-T4a, Nx or N0).
- Karnofsky Performance Scale (KPS) ≥ 70%
- Age ≥18 years old
- Adequately functioning bladder, defined as continent and without the need for an indwelling catheter
- Absolute neutrophil count (ANC) ≥ 1500/mL; platelets ≥ 100,000/mm3 serum bilirubin < 1.5 x the upper limit of normal (ULN); aspartate aminotransferase (AST) and/alanine aminotransferase (ALT) ≤ 1.5 × ULN
- Adequate renal function: calculated creatinine clearance > 30 mL/min/1.73 m2 using the following formula modified Cockcroft and Gault Formula for estimated Creatinine Clearance
- Patients must be considered able to tolerate systemic chemotherapy and pelvic radiation therapy.
- Patients must have the ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Evidence of distant disease or histologically-proven nodal metastases. Patients with radiologic evidence of lymphadenopathy must have biopsy proof of N0 status.
- Previous pelvic radiation therapy
- Prior systemic chemotherapy non-cisplatin based neoadjuvant for urothelial carcinoma (prior intravesical chemotherapy or immunotherapy is permissible)
- Prior cisplatin based neoadjuvant systemic chemotherapy for more than >4 cycles
- Active inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)
- Women who are pregnant or lactating
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York
About this study
Official title: Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
The purpose of this study is to test the safety of different amounts (doses) of external radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with chemotherapy.
- Conditions
- Bladder Cancer
- Being tested
- external radiation therapy with gemcitabine
- Keywords
- Bladder, Radiotherapy, Gemcitabine, Chemotherapy, 10-031
- 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.
external radiation therapy with gemcitabineOther
All patients will undergo daily image-guided radiation therapy with concurrent twice weekly gemcitabine chemotherapy. Radiation therapy will begin 2-4 weeks after restaging cystoscopy/fiducial marker placement.
- Dose level #1: 23.4 Gy/1.8 Gy × 13 fractions (total dose 68.4 Gy)
- Dose level #2: 27.0 Gy/1.8 Gy × 15 fractions (total dose 72.0 Gy)
- Dose level #3: 30.6 Gy/1.8 Gy × 17 fractions (total dose 75.6 Gy)
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy and Concurrent Gemcitabine Chemotherapy | Experimental | This is a Phase I dose-escalation study examining the safety and tolerability of intensity modulated external radiation therapy using image-guidance in combination with gemcitabine chemotherapy as an alternative to radical cystectomy. Receives: Other: external radiation therapy with gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the dose limiting toxicity and establish the maximal tolerated dose
Measured: 2 years
Secondary outcomes (2)
To determine the complete response rate of the primary tumor
Measured: 4-6 weeks following consolidation therapy
To determine the long term toxicity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marisa Kollmeier, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104350
- Sponsor's protocol ID
- 10-031
- Status last verified
- Mar 2026
- First submitted
- 14 Apr 2010
- Last updated
- 5 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
- ClinicalTrials.gov ID
- NCT01104350
- Acronym / sponsor ID
- 10-031
- Conditions
- Bladder Cancer
- Keywords
- Bladder, Radiotherapy, Gemcitabine, Chemotherapy, 10-031
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 15 Apr 2010 (estimated)
- 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.
The purpose of this study is to test the safety of different amounts (doses) of external radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy and Concurrent Gemcitabine Chemotherapy | Experimental | Other: external radiation therapy with gemcitabineThis is a Phase I dose-escalation study examining the safety and tolerability of intensity modulated external radiation therapy using image-guidance in combination with gemcitabine chemotherapy as an alternative to radical cystectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- MSKCC-reviewed pathologically proven diagnosis of primary bladder urothelial carcinoma without evidence of regional (nodal) or distant spread (cT1-T4a, Nx or N0).
- Karnofsky Performance Scale (KPS) ≥ 70%
- Age ≥18 years old
- Adequately functioning bladder, defined as continent and without the need for an indwelling catheter
- Absolute neutrophil count (ANC) ≥ 1500/mL; platelets ≥ 100,000/mm3 serum bilirubin < 1.5 x the upper limit of normal (ULN); aspartate aminotransferase (AST) and/alanine aminotransferase (ALT) ≤ 1.5 × ULN
Key exclusion criteria (6 listed)
- Evidence of distant disease or histologically-proven nodal metastases. Patients with radiologic evidence of lymphadenopathy must have biopsy proof of N0 status.
- Previous pelvic radiation therapy
- Prior systemic chemotherapy non-cisplatin based neoadjuvant for urothelial carcinoma (prior intravesical chemotherapy or immunotherapy is permissible)
- Prior cisplatin based neoadjuvant systemic chemotherapy for more than >4 cycles
- Active inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)
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 |
|---|---|---|
| external radiation therapy with gemcitabineAll patients will undergo daily image-guided radiation therapy with concurrent twice weekly gemcitabine chemotherapy. Radiation therapy will begin 2-4 weeks after restaging cystoscopy/fiducial marker placement. * Dose level #1: 23.4 Gy/1.8 Gy × 13 fractions (total dose 68.4 Gy) * Dose level #2: 27.0 Gy/1.8 Gy × 15 fractions (total dose 72.0 Gy) * Dose level #3: 30.6 Gy/1.8 Gy × 17 fractions (total dose 75.6 Gy) | Other | Radiotherapy and Concurrent Gemcitabine Chemotherapy |
Primary outcome
To determine the dose limiting toxicity and establish the maximal tolerated dose
Time frame: 2 years
2 secondary outcomes
To determine the complete response rate of the primary tumor
Time frame: 4-6 weeks following consolidation therapy
To determine the long term toxicity
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Marisa Kollmeier, MD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing external radiation therapy with gemcitabine in people with Bladder Cancer, run by Memorial Sloan Kettering Cancer Center at 5 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 8 inclusion and 6 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 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the dose limiting toxicity and establish the maximal tolerated dose (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.