Kidney CancerPhase 2NCT00006255
Magnetic Resonance Imaging-guided Thermal Radiofrequencey Ablation of Primary Renal Cell Carcinoma, Hepatic Metastasis, and Other Sites of Solid Organ Tumor and Metastases
A Phase 2 study testing radiofrequency ablation and thermal ablation therapy in people with Kidney Cancer and Metastatic Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Radiofrequency ablation uses high-frequency electric current to heat and kill tumor cells. Magnetic resonance imaging-guided radiofrequency ablation may an effective treatment for primary kidney cancer, liver metastases, or other solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- radiofrequency ablation and thermal ablation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2000to Mar 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of primary renal cell carcinoma, hepatic metastases, or other solid tumor meeting the following criteria:
- Not amenable to curative or substantial palliative therapy OR
- Failed chemotherapy or biological response modifier therapy OR
- Unlikely to benefit from conventional chemotherapy
- No more than 5 measurable metastatic masses in the liver
- No greater than 5 cm in diameter
- Other tumor sites allowed if location and size amenable to ablation therapy
- Measurable disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 4 months
Hematopoietic:
- Granulocyte count at least 1,000/mm^3
- Hemoglobin at least 8.0 g/dL
- Platelet count at least 100,000/mm^3
- No untreated bleeding diathesis
Hepatic:
- PT no greater than 13.5 seconds
- PT/PTT normal if prior warfarin or heparin use
Renal:
- Not specified
Cardiovascular:
- No implanted pacemaker, incompatible aneurysm clip, or other device that would preclude magnetic resonance imaging
- No myocardial infarction within the past 6 weeks
- No unstable angina
Other:
- Not pregnant or nursing
- No serious active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 28 days since prior biological response modifier therapy
Chemotherapy:
- See Disease Characteristics
- At least 28 days since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to study lesion
Surgery:
- Not specified
Other:
- At least 7 days since prior nonsteroidal antiinflammatory drugs or aspirin
- At least 1 hour since prior heparin
- No concurrent warfarin
- No concurrent investigational drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5056
About this study
Official title: A Phase II Study of Magnetic Resonance Guided and Monitored Interstitial Thermal Radiofrequency Ablation of Primary Renal Cell Carcinoma, Hepatic Metastasis, and Other Sites of Solid Organ Tumor and Metastases
RATIONALE: Radiofrequency ablation uses high-frequency electric current to heat and kill tumor cells. Magnetic resonance imaging-guided radiofrequency ablation may an effective treatment for primary kidney cancer, liver metastases, or other solid tumors.
PURPOSE: Phase II trial to study the effectiveness of magnetic-resonance-guided radiofrequency ablation in treating patients who have primary kidney cancer, liver metastases, or other solid tumors.
Read the detailed description
OBJECTIVES:
- Determine whether magnetic resonance image monitoring during radiofrequency interstitial thermal ablation can accurately predict complete destruction of focal tumor along with an adequate margin of normal tissue, as demonstrated by absence of growth on subsequent imaging studies for a 1-year period, in patients with primary renal cell carcinoma, hepatic metastases, or other solid tumors.
OUTLINE: Patients are stratified according to disease (localized hepatic metastases vs primary renal neoplasms vs solid tumors in other sites).
Patients undergo thermal ablation by radiofrequency energy under magnetic resonance guidance. Thermal ablation continues until the entire tumor is treated. Treatment ceases when the entire lesion has undergone necrosis or the zone of necrosis or significant heat deposition approaches vital neurovascular structures.
Patients are followed at 2 weeks and at 3, 6, 9, and 12 months.
PROJECTED ACCRUAL: A total of 28-39 patients will be accrued for this study within 22-36 months.
- Being tested
- radiofrequency ablation, thermal ablation therapy
- Keywords
- stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, unspecified adult solid tumor, protocol specific, liver metastases
- Medical subject headings
- Kidney Neoplasms, Neoplasm Metastasis, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationProcedure or surgery
Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.
thermal ablation therapyProcedure or surgery
Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether magnetic resonance image monitoring during radiofrequency interstitial thermal ablation can accurately predict complete destruction of focal tumor along with an adequate margin of normal tissue.
Measured: Patients are followed at 2 weeks and at 3, 6, 9, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2000
- Primary completionMar 2005
- Study completionMar 2005
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 Case Comprehensive 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- John R. Haaga, MD, Study chair, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006255
- Sponsor's protocol ID
- CWRU2Y00
- Other IDs
- P30CA043703, CWRU-2Y00, NCI-G00-1850
- Status last verified
- Jun 2010
- First submitted
- 11 Sep 2000
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Magnetic Resonance Guided and Monitored Interstitial Thermal Radiofrequency Ablation of Primary Renal Cell Carcinoma, Hepatic Metastasis, and Other Sites of Solid Organ Tumor and Metastases
- ClinicalTrials.gov ID
- NCT00006255
- Acronym / sponsor ID
- CWRU2Y00
- Keywords
- stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, unspecified adult solid tumor, protocol specific, liver metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2000
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 27 Jan 2003 (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: Radiofrequency ablation uses high-frequency electric current to heat and kill tumor cells. Magnetic resonance imaging-guided radiofrequency ablation may an effective treatment for primary kidney cancer, liver metastases, or other solid tumors.
PURPOSE: Phase II trial to study the effectiveness of magnetic-resonance-guided radiofrequency ablation in treating patients who have primary kidney cancer, liver metastases, or other solid tumors.
Detailed description
OBJECTIVES:
- Determine whether magnetic resonance image monitoring during radiofrequency interstitial thermal ablation can accurately predict complete destruction of focal tumor along with an adequate margin of normal tissue, as demonstrated by absence of growth on subsequent imaging studies for a 1-year period, in patients with primary renal cell carcinoma, hepatic metastases, or other solid tumors.
OUTLINE: Patients are stratified according to disease (localized hepatic metastases vs primary renal neoplasms vs solid tumors in other sites).
Patients undergo thermal ablation by radiofrequency energy under magnetic resonance guidance. Thermal ablation continues until the entire tumor is treated. Treatment ceases when the entire lesion has undergone necrosis or the zone of necrosis or significant heat deposition approaches vital neurovascular structures.
Patients are followed at 2 weeks and at 3, 6, 9, and 12 months.
PROJECTED ACCRUAL: A total of 28-39 patients will be accrued for this study within 22-36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| radiofrequency ablationUndergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated. | Procedure or surgery | – |
| thermal ablation therapyUndergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated. | Procedure or surgery | – |
Primary outcome
Determine whether magnetic resonance image monitoring during radiofrequency interstitial thermal ablation can accurately predict complete destruction of focal tumor along with an adequate margin of normal tissue.
Time frame: Patients are followed at 2 weeks and at 3, 6, 9, and 12 months.
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 11 Jun 2010.
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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.
John R. Haaga, MD study chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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 radiofrequency ablation and thermal ablation therapy in people with Kidney Cancer and Metastatic Cancer, run by Case Comprehensive Cancer Center 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?
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 11 Jun 2010. 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.
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?
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?
Determine whether magnetic resonance image monitoring during radiofrequency interstitial thermal ablation can accurately predict complete destruction of focal tumor along with an adequate margin of normal tissue. (time frame: Patients are followed at 2 weeks and at 3, 6, 9, and 12 months.). 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 11 Jun 2010.