Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors
18 Years
N/A
Both
Kidney Cancer
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 Center | Cleveland, Ohio 44106-5065 |
