Radiosurgery in Treating Patients With Kidney Tumors
RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.
|Kidney Cancer||Radiation: stereotactic radiosurgery Procedure: Renal Biopsy Procedure: Serum Blood Markers||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates|
- Maximum tolerated dose of radiosurgery (Phase I) [ Time Frame: once every 4 weeks ]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.
- Overall survival [ Time Frame: at 36 months from start of therapy ]Number of patients still alive after study completion
- Disease-free survival [ Time Frame: at 36 months from start of therapy ]
- Time to local progression [ Time Frame: at 36 months from start of therapy ]
- Time to distant failure (Phase II) [ Time Frame: at 36 months from start of therapy ]
|Study Start Date:||February 2007|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
|Experimental: Stereotactic radiosurgery||
Radiation: stereotactic radiosurgery
Procedure: Renal Biopsy
Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy. The radiation treatment planning and evaluation details are appended.
Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.
At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.Procedure: Serum Blood Markers
ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
- To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors.
- To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates.
Serum Blood Marker Objective:
- To determine if serum markers collected before and after radiation may give a predictive indication of tumor response.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458484
|Contact: Rodney Ellis, MDemail@example.com|
|United States, Ohio|
|University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44106-5065|
|Orange Village, Ohio, United States, 44122|
|Westlake, Ohio, United States, 44145|
|Principal Investigator:||Rodney Ellis, MD||University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center|