Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors

Study Overview
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Brief Summary
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RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with kidney tumors.

Detailed Description
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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.

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

Conditions
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Kidney Cancer

Intervention / Treatment
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* Procedure: conventional surgery
* Radiation: stereotactic radiosurgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: conventional surgery|Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.|
|Radiation: stereotactic radiosurgery|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of radiation |  | DLT is assessed at 4 and 8 weeks after radiotherapy | 
| Radiotherapy-associated toxicity |  | DLT is assessed at 4 and 8 weeks after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery | 
| Time to local progression |  | follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery | 
| Time to distant failure |  | follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery | 
| Survival |  | follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery | 
| Disease-specific survival |  | follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I renal cell cancer, stage II renal cell cancer