TCCPhase 2NCT04671407
The Aim of This Study is to Compare the Efficacy of Perioperative Hypertonic Saline 3% Versus Normal Saline (0.9%) in Decreasing Recurrence Risk in Non-muscle Invasive Bladder Cancer
A Phase 2 study testing Hypertonic Saline in people with TCC, run by Kaplan Medical Center at 1 site in Israel.
Trial summary
Purpose: to demonstrate a 10% recurrence risk reduction for patients treated with Hypersal versus normal saline immediately following TURBT. Design: prospective randomized double-blind placebo controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- TCC
- What is being tested?
- Hypertonic Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Jan 2021to 1 Dec 2022
- Phase
- Phase 2
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥18 years, men and women who are scheduled for TURBT at our center 2. Newly diagnosed papillary bladder tumors < 3cm in largest diameter at cystoscopy 3. Normal upper tracts as determined by CTU/MRU either during the 1 year before TURBT of done within one month after TURBT 4. Serum creatinine level ≤ 2.5 mg / dl before inclusion 5. Serum sodium level <145 meq/ dl before inclusion
Who cannot join
- 1. Previous diagnosis of urothelial carcinoma 2. Solid tumors or larger than 3 cm in diameter 3. Any patient with concurrent upper tract TCC by either imaging or endoscopy 4. Patients with preoperative hypernatremia >145 meq/dl 5. Patients with preoperative renal failure serum creatinine level >2.5 mg / dl 6. Patients with indwelling double J stents or when such a stent is inserted during the TURBT
- Abortion Criteria:
- Resections that mandate CBI (continuous bladder irrigation)
- Incomplete resections / endoscopic appearance of MIBC
- Suspected bladder perforation
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Kaplan MC
Rehovot
Rina Labiner, MSc, 08-9440526, rinala@clalit.org.il
About this study
Official title: Randomized Controlled Double-blind Phase II Study to Compare the Efficacy of Perioperative Hypertonic Saline 3% Versus Normal Saline (0.9%) in Decreasing Recurrence Risk in Non-muscle Invasive Bladder Cancer
Purpose: to demonstrate a 10% recurrence risk reduction for patients treated with Hypersal versus normal saline immediately following TURBT.
Design: prospective randomized double-blind placebo controlled trial. Outline: eligible patients with non-muscle invasive bladder cancer who undergo TURBT at our center will be randomized to receive either 40ml of normal saline or 40 ml of hypersal intravesically. The primary endpoint is tumor recurrence rate. Secondary endpoint are time to recurrence and side effects.
Patients A total of 150 patients will be enrolled in this trial.
Read the detailed description
Non-muscle invasive bladder cancer is associated with a high recurrence rate. As a result, clinical guidelines mandate prophylactic treatment in all patients who experience tumor recurrence after the initial resection. This is in contrast to newly diagnosed patients in whom prophylactic intravesical treatment is usually not required. Intravesical prophylaxis consists of weekly intravesical administration of either bacillus Calemtte-Guerin of cytotoxic agents including mitomycin C. This is referred to as induction of therapy followed by various maintenance protocols for periods between 6 months and 3 years duration. These recommendations stand in addition to a single perioperative dose of chemotherapy which is the subject of our research. Consequently, the observed risk reduction for a given patient receiving both a solitary perioperative dose of chemotherapy and additional doses thereafter is the combination of both regimens. To avoid possible bias from induction and maintenance therapy, we decided to include in this phase II trial only newly diagnosed patients with small, superficial-looking tumors who would receive only immediate post resection chemotherapy and would not require subsequent chemotherapy treatment.
Intervention drugs Two NaCl in sterile distilled water solutions will be used. Normal saline comes at a 0.9% concertation as opposed to hypersal with a 3% concertation volume by volume. Both solutions are colorless fluids and both will come as 40ml doses in pre-loaded syringes. All instillation syringes will be coded and the key will be kept concealed by our study coordinator assuring complete double blinding.
Intervention All included patients will undergo a routine TURBT. The number, greatest diameter and site of intravesical tumors will be recorded. Upon documented complete resection blood samples for serum sodium will be drawn from all patients . Participants will then receive a 40 ml intravesical instillation of either Hypersal or normal saline and the catheter will be plugged for 60-90 minutes. After that the catheter will be opened and allowed to drain into a urine bag and blood samples for sodium will be taken again. Patient symptoms and postoperative complications will be recorded using the same instruments used in the previous Phase I trial.
Randomization Patients will be randomized on a 1:1 basis to receive either intravesical solution using a table of random numbers between 0-1.0. All patients with an allocated number <0.5 will receive normal saline whereas all with a number of 0.5-1.0 will receive hypersal. Treatment allocations will be determined by the study coordinator before the TURBT and analyses of endpoints will be based on intention to treat.
- Conditions
- TCC
- Being tested
- Hypertonic Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic SalineDrug
Hypertonic Saline 3% and 0.9%
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Active comparator | 40ml of hypersal saline (3% NaCl) will be administered to bladder the after the surgery Receives: Drug: Hypertonic Saline |
| PLACEBO | Placebo comparator | 40ml of normal saline (0.9% NaCl) will be administered to bladder the after the surgery Receives: Drug: Hypertonic Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFICACY
All patients will be followed for one year after recruitment. During this one year period patients will undergo surveillance cystoscopy at 3 months, 6 months and 1 year following enrollment. Time to recurrence will be defined as the number of days from TURBT to recurrence at follow up cystoscopy.
Measured: 24 month E
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start20 Jan 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TCCStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled double-blind
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671407
- Sponsor's protocol ID
- Kaplan
- Status last verified
- Dec 2020
- First submitted
- 29 Nov 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Double-blind Phase II Study to Compare the Efficacy of Perioperative Hypertonic Saline 3% Versus Normal Saline (0.9%) in Decreasing Recurrence Risk in Non-muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT04671407
- Acronym / sponsor ID
- Kaplan
- Conditions
- TCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 17 Dec 2020 (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.
Purpose: to demonstrate a 10% recurrence risk reduction for patients treated with Hypersal versus normal saline immediately following TURBT.
Design: prospective randomized double-blind placebo controlled trial. Outline: eligible patients with non-muscle invasive bladder cancer who undergo TURBT at our center will be randomized to receive either 40ml of normal saline or 40 ml of hypersal intravesically. The primary endpoint is tumor recurrence rate. Secondary endpoint are time to recurrence and side effects.
Patients A total of 150 patients will be enrolled in this trial.
Detailed description
Non-muscle invasive bladder cancer is associated with a high recurrence rate. As a result, clinical guidelines mandate prophylactic treatment in all patients who experience tumor recurrence after the initial resection. This is in contrast to newly diagnosed patients in whom prophylactic intravesical treatment is usually not required. Intravesical prophylaxis consists of weekly intravesical administration of either bacillus Calemtte-Guerin of cytotoxic agents including mitomycin C. This is referred to as induction of therapy followed by various maintenance protocols for periods between 6 months and 3 years duration. These recommendations stand in addition to a single perioperative dose of chemotherapy which is the subject of our research. Consequently, the observed risk reduction for a given patient receiving both a solitary perioperative dose of chemotherapy and additional doses thereafter is the combination of both regimens. To avoid possible bias from induction and maintenance therapy, we decided to include in this phase II trial only newly diagnosed patients with small, superficial-looking tumors who would receive only immediate post resection chemotherapy and would not require subsequent chemotherapy treatment.
Intervention drugs Two NaCl in sterile distilled water solutions will be used. Normal saline comes at a 0.9% concertation as opposed to hypersal with a 3% concertation volume by volume. Both solutions are colorless fluids and both will come as 40ml doses in pre-loaded syringes. All instillation syringes will be coded and the key will be kept concealed by our study coordinator assuring complete double blinding.
Intervention All included patients will undergo a routine TURBT. The number, greatest diameter and site of intravesical tumors will be recorded. Upon documented complete resection blood samples for serum sodium will be drawn from all patients . Participants will then receive a 40 ml intravesical instillation of either Hypersal or normal saline and the catheter will be plugged for 60-90 minutes. After that the catheter will be opened and allowed to drain into a urine bag and blood samples for sodium will be taken again. Patient symptoms and postoperative complications will be recorded using the same instruments used in the previous Phase I trial.
Randomization Patients will be randomized on a 1:1 basis to receive either intravesical solution using a table of random numbers between 0-1.0. All patients with an allocated number <0.5 will receive normal saline whereas all with a number of 0.5-1.0 will receive hypersal. Treatment allocations will be determined by the study coordinator before the TURBT and analyses of endpoints will be based on intention to treat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled double-blind
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Active comparator | Drug: Hypertonic Saline40ml of hypersal saline (3% NaCl) will be administered to bladder the after the surgery |
| PLACEBO | Placebo comparator | Drug: Hypertonic Saline40ml of normal saline (0.9% NaCl) will be administered to bladder the after the surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age ≥18 years, men and women who are scheduled for TURBT at our center 2. Newly diagnosed papillary bladder tumors < 3cm in largest diameter at cystoscopy 3. Normal upper tracts as determined by CTU/MRU either during the 1 year before TURBT of done within one month after TURBT 4. Serum creatinine level ≤ 2.5 mg / dl before inclusion 5. Serum sodium level <145 meq/ dl before inclusion
Key exclusion criteria (5 listed)
- 1. Previous diagnosis of urothelial carcinoma 2. Solid tumors or larger than 3 cm in diameter 3. Any patient with concurrent upper tract TCC by either imaging or endoscopy 4. Patients with preoperative hypernatremia >145 meq/dl 5. Patients with preoperative renal failure serum creatinine level >2.5 mg / dl 6. Patients with indwelling double J stents or when such a stent is inserted during the TURBT
- Resections that mandate CBI (continuous bladder irrigation)
- Incomplete resections / endoscopic appearance of MIBC
- Suspected bladder perforation
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 |
|---|---|---|
| Hypertonic SalineHypertonic Saline 3% and 0.9% | Drug | CONTROL, PLACEBO |
Primary outcome
EFFICACY
Time frame: 24 month E
All patients will be followed for one year after recruitment. During this one year period patients will undergo surveillance cystoscopy at 3 months, 6 months and 1 year following enrollment. Time to recurrence will be defined as the number of days from TURBT to recurrence at follow up cystoscopy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: Undecided
Related trials for TCC
RecruitingPhase 3
1 Year Recurrence After Modified en Bloc Resection (ERBT) vs Transurethral Resection (TURBT) for Large Bladder Tumors
NMIBC, TCC
Active, not recruiting
Computed Tomography Urography (CTU) vs Intravenous Urography (IVU) on Patients at Risk of Urothelial Tumors
Bladder Cancer
RecruitingObservational study
uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
Urothelial Carcinoma, Urothelial Carcinoma Recurrent
Active, not recruitingPhase 2
Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium
Bladder Cancer
Enrolling by invitation
Combined Effect of TCC-I and BATD on Depressive Symptoms and Insomnia
Depression - Major Depressive Disorder, Insomnia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypertonic Saline in people with TCC, run by Kaplan Medical Center at 1 site in Israel.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFICACY (time frame: 24 month E). 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 18 Feb 2021.