NCT00891475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 13, 2014

Status Verified

February 1, 2014

Enrollment Period

1.7 years

First QC Date

April 30, 2009

Last Update Submit

February 11, 2014

Conditions

Carcinoma, Renal Cell

Keywords

metastatic renal cell carcinomaradiofrequency ablation

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    11 months

Secondary Outcomes (5)

  • Overall survival

    24 months

  • rate of complications

    1 year

  • time from the end of ablation to start of medical treatment

    3 months

  • Progression-free survival

    6 months

  • Quality of life (QOL)

    6 months

Study Arms (3)

Arm 1

EXPERIMENTAL

38 patients

Procedure: Radiofrequency ablation; Interferon-alpha

Arm 2

EXPERIMENTAL

38 patients

Procedure: Radiofrequency ablation; Sunitinib maleate

Arm 3

EXPERIMENTAL

38 patients

Drug: Sunitinib maleate

Interventions

Radiofrequency ablation; Interferon-alphaPROCEDURE

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 1
Radiofrequency ablation; Sunitinib maleatePROCEDURE

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 2
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.

Arm 3

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ilya Tsimafeyeu

Moscow, 109147, Russia

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Radiofrequency AblationInterferon-alphaSunitinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ilya V. Tsimafeyeu, MD

    KCRB

    STUDY DIRECTOR

  • Bin Chung, MD

    Beijing Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 1, 2009

Study Start

May 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2011

Last Updated

February 13, 2014

Record last verified: 2014-02

Locations

RU(1)