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


Phase 1
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

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Trial Information

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


OBJECTIVES:

Primary

- Determine the maximum tolerated dose of radiation in patients undergoing stereotactic
radiotherapy for renal tumors.

- Determine radiotherapy-associated toxicity in these patients.

Secondary

- Determine preoperative pathologic response to this regimen in these patients.

OUTLINE: This is a dose-escalation study of radiotherapy.

- Radiotherapy: Patients undergo stereotactic radiotherapy to 1 tumor. Cohorts of 4-8
patients receive escalating doses of radiotherapy twice daily for 2 days until the
maximum tolerated dose (MTD) or upper limit is reached. The MTD is defined as the dose
preceding that at which at least 2 of 4 or 3 of 8 patients experience dose-limiting
toxicity (DLT). DLT is assessed at 4 and 8 weeks after radiotherapy.

- Surgery: Two months after completion of radiotherapy, patients undergo preoperative
assessment of tumor response followed by partial nephrectomy.

After completion of study therapy, patients are followed periodically for at least 2 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Radiologically confirmed renal tumor

- At least 4 cm in greatest dimension

- No clinically, radiologically, or pathologically involved lymph nodes

- No distant metastases

PATIENT CHARACTERISTICS:

- Karnofsky performance status 70-100%

- Negative pregnancy test

- Fertile patients must use effective contraception

- Medically eligible for tumor resection

- No major medical condition or psychiatric illness that would preclude study
compliance

- No active connective tissue disease, such as lupus or dermatomyositis

- No active Crohn's disease or active ulcerative colitis

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy

- No prior abdominal or pelvic radiotherapy

- No prior cryosurgery

- No prior radiofrequency ablation

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose of radiation

Outcome Time Frame:

DLT is assessed at 4 and 8 weeks after radiotherapy

Safety Issue:

Yes

Principal Investigator

Lee E. Ponsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CASE5806

NCT ID:

NCT00445757

Start Date:

January 2007

Completion Date:

March 2010

Related Keywords:

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

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065