Radiosurgery in Treating Patients With Kidney Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Radiation: stereotactic radiosurgery Procedure: Renal Biopsy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Number of patients still alive after study completion
- Disease-free survival [ Time Frame: at 36 months from start of therapy ] [ Designated as safety issue: No ]
- Time to local progression [ Time Frame: at 36 months from start of therapy ] [ Designated as safety issue: No ]
- Time to distant failure (Phase II) [ Time Frame: at 36 months from start of therapy ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 32 |
| Study Start Date: | February 2007 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Stereotactic radiosurgery |
Radiation: stereotactic radiosurgery
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,a percutaneous renal biopsy will be obtained of the targeted tumor, under US or CT guidance.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Rodney Ellis, MD | 216-983-4769 | rodney.ellis@uhhospitals.org |
| United States, Ohio | |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44106-5065 | |
| UH-Chagrin Highlands | Recruiting |
| Orange Village, Ohio, United States, 44122 | |
| UH-Westlake | Recruiting |
| Westlake, Ohio, United States, 44145 | |
| Principal Investigator: | Rodney Ellis, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00458484 History of Changes |
| Other Study ID Numbers: | CASE12806, P30CA043703, CASE12806, NCI-2010-01064 |
| Study First Received: | April 9, 2007 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
stage I renal cell cancer stage II renal cell cancer stage III renal cell cancer stage IV renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013