Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Kidney Cancer Research Bureau.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Kidney Cancer Research Bureau
Information provided by:
Kidney Cancer Research Bureau
ClinicalTrials.gov Identifier:
NCT00891475
First received: April 30, 2009
Last updated: September 18, 2010
Last verified: September 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Renal Cell |
Procedure: Radiofrequency ablation; Interferon-alpha Procedure: Radiofrequency ablation; Sunitinib maleate Drug: Sunitinib maleate |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients With Small Primary Tumor |
Resource links provided by NLM:
Further study details as provided by Kidney Cancer Research Bureau:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: 11 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- rate of complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- time from the end of ablation to start of medical treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- time to progression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Quality of life (QOL) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 114 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
38 patients
|
Procedure: Radiofrequency ablation; Interferon-alpha
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.
|
|
Experimental: Arm 2
38 patients
|
Procedure: Radiofrequency ablation; Sunitinib maleate
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.
|
|
Experimental: Arm 3
38 patients
|
Drug: Sunitinib maleate
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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;
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891475
Contacts
| Contact: Ilya Tsimafeyeu, MD | +79265646581 | office@kidneytumor.org |
Locations
| Russian Federation | |
| Ilya Tsimafeyeu | Recruiting |
| Moscow, Russian Federation, 109147 | |
| Contact: Ilya Tsimafeyeu | |
Sponsors and Collaborators
Kidney Cancer Research Bureau
Investigators
| Study Director: | Ilya V. Tsimafeyeu, MD | KCRB |
| Principal Investigator: | Bin Chung, MD | Beijing Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Ilya Tsimafeyeu, Kidney Cancer Research Bureau |
| ClinicalTrials.gov Identifier: | NCT00891475 History of Changes |
| Other Study ID Numbers: | KCRB-003 |
| Study First Received: | April 30, 2009 |
| Last Updated: | September 18, 2010 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Kidney Cancer Research Bureau:
|
metastatic renal cell carcinoma radiofrequency ablation |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Interferon-alpha Interferon Alfa-2a Interferons |
Sunitinib Maleic acid Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013