Kidney CancerNCT00743236
Warm Ischemia or Cold Ischemia During Surgery in Treating Patients With Stage I Kidney Cancer
A study testing cold ischemia procedure and warm ischemia procedure in people with Kidney Cancer and Long-term Effects Secondary to Cancer Therapy in Adults, run by Wake Forest University Health Sciences at 8 sites in United States.
Trial summary
RATIONALE: Warm ischemia is the clamping of blood vessels without cooling the kidney. Cold ischemia is the clamping of blood vessels with kidney cooling. It is not yet known whether warm ischemia is more effective than cold ischemia in patients undergoing surgery for stage I kidney cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Kidney Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Perioperative/Postoperative Complications
- What is being tested?
- cold ischemia procedure and warm ischemia procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2008to Jun 2009
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of solitary renal cortical tumor
- Tumor size ≤ 4 cm
- Candidate for open partial nephrectomy
- Expected ischemia time < 45 minutes
- Normal renal function, defined as glomerular filtration rate (GFR) > 60 mL/min
- No evidence of distant metastasis
- No evidence of local invasion of adjacent structures, including the adrenal gland
- No evidence of tumor extension into the renal venous system
- No evidence of ureteral obstruction on MAG-3 renal scan
- No family history of renal cancer
PATIENT CHARACTERISTICS:
- ECOG performance status 0
- Life expectancy > 5 years
- No prior malignancy, except for non-melanomatous skin cancer
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210-1240
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
NYU Cancer Institute at New York University Medical Center
New York, New York, 10016
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, 92868
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function
RATIONALE: Warm ischemia is the clamping of blood vessels without cooling the kidney. Cold ischemia is the clamping of blood vessels with kidney cooling. It is not yet known whether warm ischemia is more effective than cold ischemia in patients undergoing surgery for stage I kidney cancer.
PURPOSE: This randomized phase III trial is studying warm ischemia to see how well it works compared with cold ischemia during surgery in treating patients with stage I kidney cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the effect of warm ischemia during partial nephrectomy on long-term renal function in patients with solitary stage I renal cortical tumor and normal contralateral kidney.
Secondary
- Determine to what degree the contralateral kidney compensates for the damage inflicted on the operated kidney during surgery.
- Determine the 1-year disease-specific and overall survival of these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo warm ischemia followed by partial nephrectomy.
- Arm II: Patients undergo cold ischemia followed by partial nephrectomy. Blood and urine samples are collected periodically after nephrectomy to assess renal function.
Patients are followed at 1, 3, 6, 9 , and 12 months after nephrectomy.
- Conditions
- Kidney Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Perioperative/Postoperative Complications, Urinary Complications
- Being tested
- cold ischemia procedure, warm ischemia procedure
- Keywords
- perioperative/postoperative complications, urinary complications, long-term effects secondary to cancer therapy in adults, stage I renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Postoperative Complications, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold ischemia procedureProcedure or surgery
Cold ischemia followed by partial nephrectomy
warm ischemia procedureProcedure or surgery
Warm ischemia followed by partial nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo warm ischemia followed by partial nephrectomy. Receives: Procedure: warm ischemia procedure |
| Arm II | Experimental | Patients undergo cold ischemia followed by partial nephrectomy. Receives: Procedure: cold ischemia procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine clearance at 1 year
Measured: at 1 year after nephrectomy.
Estimated glomerular filtration rate (GFR)
Measured: at 1 year after nephrectomy.
Secondary outcomes (3)
Evidence of local or metastatic recurrence
Measured: at 1 year after nephrectomy.
Cancer-specific survival
Measured: at 1 year after nephrectomy.
Overall survival
Measured: at 1 year after nephrectomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joseph A. Pettus, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743236
- Sponsor's protocol ID
- CCCWFU-89108
- Other IDs
- CDR0000612519, NCI-2009-01120
- Status last verified
- Apr 2017
- First submitted
- 27 Aug 2008
- Last updated
- 6 Apr 2017
- 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 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function
- ClinicalTrials.gov ID
- NCT00743236
- Acronym / sponsor ID
- CCCWFU-89108
- Conditions
- Kidney Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Perioperative/Postoperative Complications, Urinary Complications
- Keywords
- perioperative/postoperative complications, urinary complications, long-term effects secondary to cancer therapy in adults, stage I renal cell cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Aug 2008 (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.
RATIONALE: Warm ischemia is the clamping of blood vessels without cooling the kidney. Cold ischemia is the clamping of blood vessels with kidney cooling. It is not yet known whether warm ischemia is more effective than cold ischemia in patients undergoing surgery for stage I kidney cancer.
PURPOSE: This randomized phase III trial is studying warm ischemia to see how well it works compared with cold ischemia during surgery in treating patients with stage I kidney cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the effect of warm ischemia during partial nephrectomy on long-term renal function in patients with solitary stage I renal cortical tumor and normal contralateral kidney.
Secondary
- Determine to what degree the contralateral kidney compensates for the damage inflicted on the operated kidney during surgery.
- Determine the 1-year disease-specific and overall survival of these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo warm ischemia followed by partial nephrectomy.
- Arm II: Patients undergo cold ischemia followed by partial nephrectomy. Blood and urine samples are collected periodically after nephrectomy to assess renal function.
Patients are followed at 1, 3, 6, 9 , and 12 months after nephrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: warm ischemia procedurePatients undergo warm ischemia followed by partial nephrectomy. |
| Arm II | Experimental | Procedure: cold ischemia procedurePatients undergo cold ischemia followed by partial nephrectomy. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cold ischemia procedureCold ischemia followed by partial nephrectomy | Procedure or surgery | Arm II |
| warm ischemia procedureWarm ischemia followed by partial nephrectomy | Procedure or surgery | Arm I |
Primary outcome
Creatinine clearance at 1 year
Time frame: at 1 year after nephrectomy.
Estimated glomerular filtration rate (GFR)
Time frame: at 1 year after nephrectomy.
3 secondary outcomes
Evidence of local or metastatic recurrence
Time frame: at 1 year after nephrectomy.
Cancer-specific survival
Time frame: at 1 year after nephrectomy.
Overall survival
Time frame: at 1 year after nephrectomy.
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 6 Apr 2017.
- 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.
Joseph A. Pettus, MD study chair
Wake Forest University Health Sciences
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold ischemia procedure and warm ischemia procedure in people with Kidney Cancer and Long-term Effects Secondary to Cancer Therapy in Adults, run by Wake Forest University Health Sciences at 8 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?
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 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
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?
Creatinine clearance at 1 year (time frame: at 1 year after nephrectomy.). The study lists 2 primary outcomes in all. 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 6 Apr 2017.