Stage 0a Renal Pelvis and Ureter Cancer AJCC v8Phase 2NCT04398368
Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study
A Phase 2 study testing Gemcitabine Hydrochloride in people with Stage 0a Renal Pelvis and Ureter Cancer AJCC v8 and Stage 0a Renal Pelvis Cancer AJCC v8, run by Mayo Clinic at 4 sites in United States.
Trial summary
This phase II trial studies how well gemcitabine works in preventing urothelial cancer from coming back within the bladder (intravesical recurrence) in patients with upper urinary tract urothelial cancer undergoing radical nephroureterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage 0a Renal Pelvis and Ureter Cancer AJCC v8, Stage 0a Renal Pelvis Cancer AJCC v8, Stage 0a Ureter Cancer AJCC v8
- What is being tested?
- Gemcitabine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Jun 2020to 2 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of localized (clinical American Joint Committee on Cancer [AJCC] stage Ta-T4N0M0) low- and high-grade UC of the renal pelvis and/or ureter
- Plan to undergo RNU
- Creatinine < 2.2 mg/dL (194 mmol/L)
- Hemoglobin > 9 g/dL
- White blood cell count >= 3000/uL
- Platelet count > 75,000/uL and < 500,000/uL
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- Serum bilirubin levels below 2 times the institution's upper limits of normal
- Alkaline phosphatase levels below 2 times the institution's upper limits of normal
- Aspartate aminotransferase levels below 2 times the institution's upper limits of normal
- Alanine aminotransferase levels below 2 times the institution's upper limits of normal
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
- Suitable candidate for surgery at the discretion of the investigator
- Patient must be capable of giving appropriate approved informed consent or have an appropriate representative available to do
- Patient with a prior malignancy allowed if adequately treated > 3 years ago with no current evidence of disease
- Women of childbearing potential (WOCBP) must have a negative pregnancy urine test within 28 days of registration, and be using an adequate method of contraception to avoid pregnancy prior to and for at least 6 months after gemcitabine instillation to minimize the risk of pregnancy
- Male patient who has a partner that is a WOCBP must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) and should avoid conceiving children prior to and for 6 months following gemcitabine instillation
Who cannot join
- Pure non-urothelial histology; urothelial carcinoma with differentiation allowed
- Evidence of nodal or distant metastases; enlarged retroperitoneal lymph nodes > 2 cm or histologically positive lymph nodes
- History of UC of the bladder within 12 months preceding RNU, or receipt of intravesical therapy within 6 months
- History of or current prostatic urethral, urethral, or contralateral upper tract UC
- Planned radical cystectomy at time of RNU
- Symptomatic urinary tract infection of bacterial cystitis (once satisfactorily treated, patients can enter the study)
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- Patient with any current malignancy except for basal or squamous cell skin cancers, noninvasive cancer of the cervix, or any other cancer deemed to be of low-risk for progression or patient morbidity during the trial period (i.e. Gleason 6 prostate cancer, renal mass < 3 cm)
- Women who are pregnant or breastfeeding
- Prisoners or subjects who are involuntarily incarcerated
- Inability for adequate follow-up, including concerns for patient compliance or geographic proximity
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: GEMINI: An Open-Label, Single-Arm, Phase II Study of Intraoperative Gemcitabine Intravesical Instillation in Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma
This phase II trial studies how well gemcitabine works in preventing urothelial cancer from coming back within the bladder (intravesical recurrence) in patients with upper urinary tract urothelial cancer undergoing radical nephroureterectomy. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Instilling gemcitabine into the bladder during surgery, may reduce the chance of recurrence of upper urinary tract urothelial cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the efficacy of a single intraoperative intravesical instillation of gemcitabine hydrochloride (gemcitabine) at time of radical nephroureterectomy (RNU) for clinically localized upper tract urothelial carcinoma (UTUC) in preventing intravesical recurrence of urothelial cancer (UC) at one year.
SECONDARY OBJECTIVES:
- To assess time to recurrence for entire duration of follow-up. II. To assess the qualitative and quantitative toxicities.
EXPLORATORY OBJECTIVES:
- To stratify intravesical UC recurrence free survival by tumor grade, neoadjuvant chemotherapy, tumor stage, ureteral tumor location, and history of bladder cancer.
II. To assess incidence and time to development of muscle-invasive bladder cancer (MIBC).
OUTLINE:
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
After completion of study, patients are followed up at 2 weeks, and 3, 6, 12, 18, and 24 months.
- Conditions
- Stage 0a Renal Pelvis and Ureter Cancer AJCC v8, Stage 0a Renal Pelvis Cancer AJCC v8, Stage 0a Ureter Cancer AJCC v8, Stage 0is Renal Pelvis and Ureter Cancer AJCC v8, Stage 0is Renal Pelvis Cancer AJCC v8, Stage 0is Ureter Cancer AJCC v8
- Being tested
- Gemcitabine Hydrochloride
- Medical subject headings
- Ureteral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, FF 10832, FF-10832
Given intravesically
| Study group | Role | What they receive |
|---|---|---|
| Prevention (gemcitabine hydrochloride) | Experimental | Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU. Receives: Drug: Gemcitabine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urothelial Carcinoma Relapse-free Survival
Number of participants without recurrence of Urothelial Carcinoma. Relapse-free survival will be assessed by cystoscopy and urine cytology.
Measured: Up to 1 year
Secondary outcomes (2)
Time to Recurrence
Number of days from Radical Nephroureterectomy to date of histologic proof of recurrence/relapse of Urothelial Carcinoma
Measured: Up to 1 year
Incidence of Adverse Events
Adverse events will be categorized by grade and further distinguished as serious adverse events. Furthermore, they will be designated by each site as not related, unlikely, possible, probably, and definitely related to treatment adverse events. they will also be summarized and organized by organ system, with the number and percent of patients experiencing the adverse event at least once and the number of patients exposed. Adverse events will be described and analyzed qualitatively. Adverse events will be grouped into categories and numerically described.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start5 Jun 2020
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Why it stopped: Focus research efforts on other projects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage 0a Renal Pelvis and Ureter Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen A. Boorjian, M.D., Mayo Clinic
- Investigators
- Stephen A Boorjian, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398368
- Sponsor's protocol ID
- 19-009444
- Other IDs
- NCI-2020-03336, 19-009444
- Status last verified
- Jul 2023
- First submitted
- 16 May 2020
- Last updated
- 8 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GEMINI: An Open-Label, Single-Arm, Phase II Study of Intraoperative Gemcitabine Intravesical Instillation in Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT04398368
- Acronym / sponsor ID
- 19-009444
- Conditions
- Stage 0a Renal Pelvis and Ureter Cancer AJCC v8, Stage 0a Renal Pelvis Cancer AJCC v8, Stage 0a Ureter Cancer AJCC v8, Stage 0is Renal Pelvis and Ureter Cancer AJCC v8, Stage 0is Renal Pelvis Cancer AJCC v8, Stage 0is Ureter Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Focus research efforts on other projects.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Posted 8 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well gemcitabine works in preventing urothelial cancer from coming back within the bladder (intravesical recurrence) in patients with upper urinary tract urothelial cancer undergoing radical nephroureterectomy. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Instilling gemcitabine into the bladder during surgery, may reduce the chance of recurrence of upper urinary tract urothelial cancer.
Detailed description
PRIMARY OBJECTIVE:
- To determine the efficacy of a single intraoperative intravesical instillation of gemcitabine hydrochloride (gemcitabine) at time of radical nephroureterectomy (RNU) for clinically localized upper tract urothelial carcinoma (UTUC) in preventing intravesical recurrence of urothelial cancer (UC) at one year.
SECONDARY OBJECTIVES:
- To assess time to recurrence for entire duration of follow-up. II. To assess the qualitative and quantitative toxicities.
EXPLORATORY OBJECTIVES:
- To stratify intravesical UC recurrence free survival by tumor grade, neoadjuvant chemotherapy, tumor stage, ureteral tumor location, and history of bladder cancer.
II. To assess incidence and time to development of muscle-invasive bladder cancer (MIBC).
OUTLINE:
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
After completion of study, patients are followed up at 2 weeks, and 3, 6, 12, 18, and 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (gemcitabine hydrochloride) | Experimental | Drug: Gemcitabine HydrochloridePatients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Clinical diagnosis of localized (clinical American Joint Committee on Cancer [AJCC] stage Ta-T4N0M0) low- and high-grade UC of the renal pelvis and/or ureter
- Plan to undergo RNU
- Creatinine < 2.2 mg/dL (194 mmol/L)
- Hemoglobin > 9 g/dL
- White blood cell count >= 3000/uL
Key exclusion criteria (10 listed)
- Pure non-urothelial histology; urothelial carcinoma with differentiation allowed
- Evidence of nodal or distant metastases; enlarged retroperitoneal lymph nodes > 2 cm or histologically positive lymph nodes
- History of UC of the bladder within 12 months preceding RNU, or receipt of intravesical therapy within 6 months
- History of or current prostatic urethral, urethral, or contralateral upper tract UC
- Planned radical cystectomy at time of RNU
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 |
|---|---|---|
| Gemcitabine HydrochlorideAlso: dFdCyd, Difluorodeoxycytidine Hydrochloride, FF 10832, FF-10832Given intravesically | Drug | Prevention (gemcitabine hydrochloride) |
Primary outcome
Urothelial Carcinoma Relapse-free Survival
Time frame: Up to 1 year
Number of participants without recurrence of Urothelial Carcinoma. Relapse-free survival will be assessed by cystoscopy and urine cytology.
2 secondary outcomes
Time to Recurrence
Time frame: Up to 1 year
Incidence of Adverse Events
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Stephen A Boorjian principal investigator
Mayo Clinic
4 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 Gemcitabine Hydrochloride in people with Stage 0a Renal Pelvis and Ureter Cancer AJCC v8 and Stage 0a Renal Pelvis Cancer AJCC v8, run by Mayo Clinic at 4 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 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 8 Aug 2023). 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?
Urothelial Carcinoma Relapse-free Survival (time frame: Up to 1 year). 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 8 Aug 2023.