Invasive Bladder CancerNCT03514888
HIPEC After Radical Cystectomy for High Risk Bladder Cancer
A study testing HIPEC in people with Invasive Bladder Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This is a non-randomized, non-blinded, pilot study administering hyperthermic intraperitoneal chemotherapy with Mitomycin-C in 10 men and women with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with pelvic lymph node dissection who have risk factors for tumor recurrence. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Invasive Bladder Cancer
- What is being tested?
- HIPEC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2018to 23 May 2023
- Phase
- Interventional
- 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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary urothelial cell carcinoma of the bladder
- Patient's aged 45-85, both genders.
- ECOG performance status < 1
- Hematology: ANC > 1.5x109/L; Platelets > 100x109/L
- Women with child bearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
- Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.
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- Either any of the following preoperative factors for increased risk of recurrence:
- Lymphovascular invasion
- Variant histology in the background of primary urothelial (notably plasmacytoid)
- Clinical T3 or greater
- Clinical N+
- No prior neoadjuvant chemotherapy (NAC) or lack of response to NAC
- Or any of the following perioperative factors for increased risk of recurrence:
- Palpable concern for extravesical disease
- Tumor spillage/bladder entry
- Suspicious nodes or positive intraoperative frozen sections
Who cannot join
- Subjects who have previously undergone intraperitoneal chemotherapy.
- Subjects with tumor histology other than urothelial cell carcinoma.
- Patients on concurrent anti-cancer therapy other than that allowed in the study.
- Other prior malignancies, except for cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix or adequately treated malignancies for which there has been no evidence of activity for more than 3 years.
- Subjects with renal insufficiency defined as creatinine > 1.5x the upper limit of normal or a calculated creatinine clearance of < 50 cc/min.
- Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
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- Known HIV, Hepatitis B or Hepatitis C positive.
- Subjects with uncontrolled concurrent illness including, but not limited to, ongoing or severe infection requiring antibiotics, symptomatic congestive heart failure, unstable angina pectoris, acute gastrointestinal bleeding, psychiatric illness or other condition which in the opinion of the investigator, places the patient at an unacceptable risk for participation in the study.
- Any condition that would preclude the ability to deliver appropriate IP therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York, 10065
About this study
Official title: A Pilot Study for Hyperthermic Intraperitoneal Chemotherapy After Radical Cystectomy With Pelvic Lymph Node Dissection for High Risk Invasive Bladder Cancer
This is a non-randomized, non-blinded, pilot study administering hyperthermic intraperitoneal chemotherapy with Mitomycin-C in 10 men and women with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with pelvic lymph node dissection who have risk factors for tumor recurrence.
- Conditions
- Invasive Bladder Cancer
- Being tested
- HIPEC
- Keywords
- High-risk bladder cancer, Urothelial cancer, HIPEC, Mitomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPECProcedure or surgery
Also called Hyperthermic intraperitoneal chemotherapy
40mg of Mitomycin-C dissolved in 100ml normal saline will be added into the perfusate and instilled into the patient for a total of 60 minutes. After 60 minutes, the abdomen will be irrigated with 3 liters of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| HIPEC after Radical Cystectomy | Experimental | After completion of radical cystectomy, HIPEC will be administered using closed abdomen technique for a duration of 60 minutes. Receives: Procedure: HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment toxicity
Treatment toxicity will be analyzed using NCI Common Terminology Criteria for Adverse Events-Version 4.0. Descriptive statistics will be used to determine proportion of grade III/V treatment toxicity. Expected grade III/V toxicity in surgical patients without HIPEC would be 3 out of 10 patients. With the addition of HIPEC, there would be a significant difference (p=0.05) if 6 out of 10 patients experienced a grade III/V toxicity. Therefore, if less than 6 patients experience a grade III/V we would consider this a "negative" finding.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start19 Apr 2018
- Primary completion19 Jul 2021
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- HIPEC with Mitomycin-C
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas S Scherr, MD, Principal investigator, Weill Cornell Medicine - New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514888
- Sponsor's protocol ID
- 1708018468
- Status last verified
- Aug 2023
- First submitted
- 20 Apr 2018
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Hyperthermic Intraperitoneal Chemotherapy After Radical Cystectomy With Pelvic Lymph Node Dissection for High Risk Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT03514888
- Acronym / sponsor ID
- 1708018468
- Conditions
- Invasive Bladder Cancer
- Keywords
- High-risk bladder cancer, Urothelial cancer, HIPEC, Mitomycin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 2 May 2018 (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.
This is a non-randomized, non-blinded, pilot study administering hyperthermic intraperitoneal chemotherapy with Mitomycin-C in 10 men and women with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with pelvic lymph node dissection who have risk factors for tumor recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- HIPEC with Mitomycin-C
| Arm | Type | Receives |
|---|---|---|
| HIPEC after Radical Cystectomy | Experimental | Procedure: HIPECAfter completion of radical cystectomy, HIPEC will be administered using closed abdomen technique for a duration of 60 minutes. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Primary urothelial cell carcinoma of the bladder
- Patient's aged 45-85, both genders.
- ECOG performance status < 1
- Hematology: ANC > 1.5x109/L; Platelets > 100x109/L
- Women with child bearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
Key exclusion criteria (9 listed)
- Subjects who have previously undergone intraperitoneal chemotherapy.
- Subjects with tumor histology other than urothelial cell carcinoma.
- Patients on concurrent anti-cancer therapy other than that allowed in the study.
- Other prior malignancies, except for cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix or adequately treated malignancies for which there has been no evidence of activity for more than 3 years.
- Subjects with renal insufficiency defined as creatinine > 1.5x the upper limit of normal or a calculated creatinine clearance of < 50 cc/min.
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 |
|---|---|---|
| HIPECAlso: Hyperthermic intraperitoneal chemotherapy40mg of Mitomycin-C dissolved in 100ml normal saline will be added into the perfusate and instilled into the patient for a total of 60 minutes. After 60 minutes, the abdomen will be irrigated with 3 liters of normal saline. | Procedure or surgery | HIPEC after Radical Cystectomy |
Primary outcome
Treatment toxicity
Time frame: 90 days
Treatment toxicity will be analyzed using NCI Common Terminology Criteria for Adverse Events-Version 4.0. Descriptive statistics will be used to determine proportion of grade III/V treatment toxicity. Expected grade III/V toxicity in surgical patients without HIPEC would be 3 out of 10 patients. With the addition of HIPEC, there would be a significant difference (p=0.05) if 6 out of 10 patients experienced a grade III/V toxicity. Therefore, if less than 6 patients experience a grade III/V we would consider this a "negative" finding.
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 28 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Douglas S Scherr, MD principal investigator
Weill Cornell Medicine - New York Presbyterian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIPEC in people with Invasive Bladder Cancer, run by Weill Medical College of Cornell University at 1 site 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 9 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 28 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 1 site 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.
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?
Treatment toxicity (time frame: 90 days). 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 28 Aug 2023.