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Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

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Trial Information

Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates


OBJECTIVES:

Primary

- To evaluate and compare the clinical safety of utilizing four different schemes of
radiosurgical ablative techniques for treating poor surgical candidates with renal
tumors.

Secondary

- To evaluate and compare the clinical and radiographic efficacy of four different
schemes of radiosurgical ablation of renal tumors in poor surgical candidates.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients undergo placement of 2-3 fiducial markers in or near the renal tumor. Patients then
undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or
unacceptable toxicity. Treatment may repeat at 6 months if tumor is still present.

After radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months
post radiosurgery for a total of 36 months.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.


Inclusion Criteria:



- Patient is considered a poor surgical candidate for removal of renal mass as
determined by anesthesiology pre-operative assessment or the surgical team, medical
team. (No major psychiatric illnesses.)

- Patient is able to give and sign study specific informed consent

- No prior pelvic or abdominal radiation

- Negative serum or urine pregnancy test within 72 hours prior to registration for
women of childbearing potential

- Patient has a radiologically and /or pathologically confirmed diagnosis of a renal
tumor

- Karnofsky status of >= 60%

- Signed study-specific informed consent prior to study entry

Exclusion Criteria:

- Any patient not meeting the eligibility criteria.

- Any patient with active connective tissue disease such as lupus, dermatomyositis.

- Any patient with active Crohn's disease or active ulcerative colitis.

- Major psychiatric illness, which would prevent completion of treatment or interfere
with follow-up.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of radiosurgery (Phase I)

Outcome Description:

Acute Radiation Toxicity ≥ grade 3 in the Gastrointestinal and renal/genitourinary categories of the common terminology criteria for adverse events 4.0 (CTCAE) will be considered dose limiting. The maximum tolerated dose will be one dose level below which the adverse event, as described above, occurred.

Outcome Time Frame:

once every 4 weeks

Safety Issue:

Yes

Principal Investigator

Rodney Ellis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CASE12806

NCT ID:

NCT00458484

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage I renal cell cancer
  • stage II renal cell cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
UH-Chagrin Highlands Orange Village, Ohio  44122
UH-Westlake Westlake, Ohio  44145