Carcinoma, Renal CellPhase 1/2NCT00891475
Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients
A Phase 1/2 study testing Radiofrequency ablation; Interferon-alpha, Radiofrequency ablation; Sunitinib maleate and Sunitinib maleate in people with Carcinoma, Renal Cell, run by Kidney Cancer Research Bureau at 1 site in Russia.
Trial summary
The purpose of this study is to evaluate efficacy and safety of Radiofrequency ablation in metastatic renal cell carcinoma patients with primary tumor less than 5 cm before medical treatment. Ablation may allow for reduced morbidity and may increase the likelihood of patients receiving systemic therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Radiofrequency ablation; Interferon-alpha, Radiofrequency ablation; Sunitinib maleate and Sunitinib maleate
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteRussia
- Study dates
- May 2008to Jan 2011
- Phase
- Phase 1/2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven renal cell carcinoma before RFA;
- Primary tumor no grater than 5 cm;
- CT-confirmed metastatic measurable sites;
- Good prognosis by adapted MSKCC criteria;
- No treatment for RCC;
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients With Small Primary Tumor
The purpose of this study is to evaluate efficacy and safety of Radiofrequency ablation in metastatic renal cell carcinoma patients with primary tumor less than 5 cm before medical treatment. Ablation may allow for reduced morbidity and may increase the likelihood of patients receiving systemic therapy.
Read the detailed description
Nephrectomy has become an integral part of the management of patients with metastatic kidney cancer. Performing nephrectomy in these patients is not without risk, however. The very real chance of significant metastatic disease progression during the postoperative period or complication before or during surgery that may prolong postoperative recovery could potentially delay or prevent the administration of systemic therapy in the postoperative period. Patient selection for surgery remains critical for success.
Radiofrequency ablation (RFA) is a medical procedure where tumor is ablated using microwave energy to treat a medical disorder. The benefits of RFA in selected metastatic renal cell carcinoma patients with small primary tumor (<5 cm) will be evaluated in this Phase I/II study.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Radiofrequency ablation; Interferon-alpha, Radiofrequency ablation; Sunitinib maleate, Sunitinib maleate
- Keywords
- metastatic renal cell carcinoma, radiofrequency ablation
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation; Interferon-alphaProcedure or surgery
Patients undergo ablation by radiofrequency energy under CT-guidance. RFA 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. 38 patients will receive following immunotherapy with Interferon-alpha 9 MIU subcutaneously three times per week, 3 weeks on, 3 weeks off till progression. 38 patients will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off till progression. Evaluation for response will be after second cycle.
Radiofrequency ablation; Sunitinib maleateProcedure or surgery
Patients undergo ablation by radiofrequency energy under CT-guidance. RFA 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. 38 patients will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off, till progression. Evaluation for response will be after second cycle.
Sunitinib maleateDrug
38 patients with unresected primary tumor will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off, till progression. Evaluation for response will be after second cycle.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 38 patients Receives: Procedure: Radiofrequency ablation; Interferon-alpha |
| Arm 2 | Experimental | 38 patients Receives: Procedure: Radiofrequency ablation; Sunitinib maleate |
| Arm 3 | Experimental | 38 patients Receives: Drug: Sunitinib maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 11 months
Secondary outcomes (5)
Overall survival
Measured: 24 months
rate of complications
Measured: 1 year
time from the end of ablation to start of medical treatment
Measured: 3 months
Progression-free survival
Measured: 6 months
Quality of life (QOL)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startMay 2008
- Primary completionJan 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kidney Cancer Research Bureau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilya V. Tsimafeyeu, MD, Study director, KCRBBin Chung, MD, Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891475
- Sponsor's protocol ID
- KCRB-003
- Status last verified
- Feb 2014
- First submitted
- 30 Apr 2009
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients With Small Primary Tumor
- ClinicalTrials.gov ID
- NCT00891475
- Acronym / sponsor ID
- KCRB-003
- Conditions
- Carcinoma, Renal Cell
- Keywords
- metastatic renal cell carcinoma, radiofrequency ablation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Kidney Cancer Research BureauUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 1 May 2009 (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.
The purpose of this study is to evaluate efficacy and safety of Radiofrequency ablation in metastatic renal cell carcinoma patients with primary tumor less than 5 cm before medical treatment. Ablation may allow for reduced morbidity and may increase the likelihood of patients receiving systemic therapy.
Detailed description
Nephrectomy has become an integral part of the management of patients with metastatic kidney cancer. Performing nephrectomy in these patients is not without risk, however. The very real chance of significant metastatic disease progression during the postoperative period or complication before or during surgery that may prolong postoperative recovery could potentially delay or prevent the administration of systemic therapy in the postoperative period. Patient selection for surgery remains critical for success.
Radiofrequency ablation (RFA) is a medical procedure where tumor is ablated using microwave energy to treat a medical disorder. The benefits of RFA in selected metastatic renal cell carcinoma patients with small primary tumor (<5 cm) will be evaluated in this Phase I/II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: Radiofrequency ablation; Interferon-alpha38 patients |
| Arm 2 | Experimental | Procedure: Radiofrequency ablation; Sunitinib maleate38 patients |
| Arm 3 | Experimental | Drug: Sunitinib maleate38 patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven renal cell carcinoma before RFA;
- Primary tumor no grater than 5 cm;
- CT-confirmed metastatic measurable sites;
- Good prognosis by adapted MSKCC criteria;
- No treatment for RCC;
Key exclusion criteria (0 listed)
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 ablation; Interferon-alphaPatients undergo ablation by radiofrequency energy under CT-guidance. RFA 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. 38 patients will receive following immunotherapy with Interferon-alpha 9 MIU subcutaneously three times per week, 3 weeks on, 3 weeks off till progression. 38 patients will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off till progression. Evaluation for response will be after second cycle. | Procedure or surgery | Arm 1 |
| Radiofrequency ablation; Sunitinib maleatePatients undergo ablation by radiofrequency energy under CT-guidance. RFA 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. 38 patients will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off, till progression. Evaluation for response will be after second cycle. | Procedure or surgery | Arm 2 |
| Sunitinib maleate38 patients with unresected primary tumor will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off, till progression. Evaluation for response will be after second cycle. | Drug | Arm 3 |
Primary outcome
Progression-free survival
Time frame: 11 months
5 secondary outcomes
Overall survival
Time frame: 24 months
rate of complications
Time frame: 1 year
time from the end of ablation to start of medical treatment
Time frame: 3 months
Progression-free survival
Time frame: 6 months
Quality of life (QOL)
Time frame: 6 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 13 Feb 2014.
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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.
Ilya V. Tsimafeyeu, MD study director
KCRB
Bin Chung, MD principal investigator
Beijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Radiofrequency ablation; Interferon-alpha, Radiofrequency ablation; Sunitinib maleate and Sunitinib maleate in people with Carcinoma, Renal Cell, run by Kidney Cancer Research Bureau at 1 site in Russia.
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 5 inclusion and 0 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 13 Feb 2014. 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 Russia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Progression-free survival (time frame: 11 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 13 Feb 2014.