NCT00807339

Brief Summary

This is a dose escalation study using the CyberKnife radiotherapy device for small surgical or medically untreatable renal tumors. Patients with renal tumors 5cms or less in diameter will be accrued onto this study. The ability of CyberKnife to ablate these renal tumors and maintain renal function with dose escalation will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

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

March 1, 2006

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2014

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

7.8 years

First QC Date

December 10, 2008

Last Update Submit

March 20, 2017

Conditions

Renal Cancer

Keywords

CyberKnife

Outcome Measures

Primary Outcomes (1)

  • To determine the maximum tolerated dose of CyberKnife radiation

    2 years

Secondary Outcomes (1)

  • To evaluate local control, overall survival and late toxicity including preservation of renal function

    2 years

Study Arms (1)

1

EXPERIMENTAL

Phase I dose escalation

Radiation: Stereotactic radiationDevice: CyberKnife Robotic Radiosurgery System

Interventions

Stereotactic radiationRADIATION

Dose escalation three consecutive treatments

1
CyberKnife Robotic Radiosurgery SystemDEVICE
1

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tumor size 5 cm or less
  • Radiographic evidence of malignancy or Histologically verified primary renal malignancy.
  • If the kidney biopsy is inconclusive but the radiologist determines that the tumor based on the CT/MRI is highly suspicious for cancer, you may participate
  • Patients with highly suspicious lesions on CT or MRI
  • One -three gold fiducials placed in or around tumor
  • Contradiction or patient refusal to partial or complete nephrectomy
  • Age 18 or greater
  • KPS score 70 or greater

You may not qualify if:

  • Irreversible coagulopathies that preclude fiducial placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Radiation Oncology

Study Record Dates

First Submitted

December 10, 2008

First Posted

December 11, 2008

Study Start

March 1, 2006

Primary Completion

January 1, 2014

Study Completion

August 20, 2014

Last Updated

March 21, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)