Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients

NCT ID: NCT00891475

Last Updated: 2014-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-01-31

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

38 patients

Group Type: EXPERIMENTAL

Radiofrequency ablation; Interferon-alpha

Intervention Type: PROCEDURE

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.

Arm 2

38 patients

Group Type: EXPERIMENTAL

Radiofrequency ablation; Sunitinib maleate

Intervention Type: PROCEDURE

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.

Arm 3

38 patients

Group Type: EXPERIMENTAL

Sunitinib maleate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kidney Cancer Research Bureau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilya V. Tsimafeyeu, MD

Role: STUDY_DIRECTOR

KCRB

Bin Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital

Locations

Ilya Tsimafeyeu

Moscow, , Russia

Countries

Russia

Other Identifiers

KCRB-003

Identifier Type: -

Identifier Source: org_study_id